What is "Translational Research"?

To improve human health, scientific discoveries must be translated into practical applications. These discoveries typically begin at “the bench” with basic research, in which scientists study disease at  the molecular and cellular levels, then progress to the clinical level, or the patient’s “bedside.”

This “bench-to-bedside” approach in translational research is actually a two-way street. Basic scientists provide clinical researchers with new patient care tools to assess through clinical trials, and clinical researchers make novel observations about the nature and progression of disease that often stimulate basic scientists’ investigations.

The combined efforts of scientists, researchers, and physicians make translational research a true interdisciplinary approach to improving lives through innovation that leads to discoveries and ultimately cures.

Clinical Trials & Research Studies

The TRI is currently conducting the following research studies.  Please join our mailing list to receive e-mail updates as new research studies become available.

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ACME (Type 1 Diabetes)

Study Status:   Active-Open Enrollment

Study Name:    ACME

Study Focus:    Patients with Type 1 Diabetes

Study Contact:  To learn more, please call Call1-877-854-8475 or fill out Contact Us form

Study Purpose:  To develop a comprehensive model of energy balance and metabolic flexibility for Type 1 diabetes

To be enrolled in this study, you must meet certain requirements.  You are eligible to participate if you meet the following criteria:

  • Age 19-30
  • Type 1 Diabetics, Healthy Lean, Overweight, or Obese subjects
  • A1c 6.5-13%
  • BMI 18-39

Study Duration:

  • Phase 1 up to 39 days
  • Phase 2 up to 68 days

Study Commitment: 

  • Phase 1
    • 1 Screening Visit
    • Total of 3 overnight Stays
    • Total of 1 outpatient Visit
    • Total of 2 phone Calls
  • Phase 2
    • Total of 3 overnight Stays
    • Total of 2 outpatient Visits
    • Total of 7 phone Calls

Study Procedures:

  • Physical Exam, vital signs, height, and weight, measurement of waist circumference
  • Stool Collection
  • Multiple blood draws and urine collection
  • Pregnancy Test
  • FibroScan
  • Dexa Scan
  • MRI
  • Calorimetry
  • Dietary Counseling  

Compensation offered up to $1495.00

This study is being conducted under the direction of Dr. Richard Pratley, at 301 East Princeton Street, Orlando, Florida 32804

C-40000 (A1c and Glucose)

Study Status: Active - Open to Enrollment

Study Name: C-40000

Study Focus: A1c and Glucose

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact us form.

Study Purpose: The purpose of this study is to learn more about the use of the RevitaTM System for the treatment of Type 2 diabetes.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the following criteria:

  • 28-65 years of age
  • BMI 28-40 kg/m2
  • Type II Diabetes (at least three years)
  • Prescribed with 2 OADs, one of them Metformin

Study Duration: up to 60 weeks

Study Commitment:

  • 3 Screening visits
  • Up to 11 Outpatient visits (including procedure visit)
  • Up to 10 Phone calls

Study Procedures:

  • Physical exam, vital signs, height, and weight, EKG, fasting labs
  • IV insertion
  • Multiple blood draws
  • Phone calls
  • Urine Screen
  • Pregnancy Test
  • MRI
  • Endoscopy (Duodenal Mucosal Resurfacing [DMR] or Sham procedure)
  • Biopsy during endoscopy at week 24 (only DMR patients)
  • Questionnaires
  • Diary completion

Compensation offered up to $ 2,325 to cover visit related expenses

This study is being conducted under the direction of Dr. Steven Smith at 301 East Princeton Street, Orlando, Florida 32804.

GO-ID (Rhythm)

Study Status: Active-Open to Enrollment

Study Name: Rhythm

Study Focus: Genetics of Obesity

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact us form.

Study Purpose: The purpose of this study is to identify people who have a rare genetic cause of obesity. We are currently conducting this genetic screening study to possibly identify people that may have rare genetic causes of obesity. Depending on your results, you may be eligible for further assessment of clinical features including: weight, medical history, current hunger and feeding behaviors.

To be enrolled in this study, you must meet certain requirements. You are eligible to participate in one of the following groups if you meet the associated criteria:

  • Adults
  • 18 -30 years of age
  • BMI ≥40 kg/m2

Study Commitment:

  • 1 Screening visit

Study Procedures:

  • Blood collection for DNA analysis

Compensation offered? No

This study is being conducted under the direction of Dr. Steven Smith, MD at 301 East Princeton Street, Orlando, Florida 32804.

MATPET (Exercise, Muscle, and Glucose)

Study Status: Active-Open to Enrollment

Study Name: MATPET     

Study Focus:   Exercise, Muscle, and Glucose

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact us form.

Study Purpose:  To obtain a better understanding of the relationships between exercise, skeletal muscle characteristics, and your ability to metabolize glucose. 

To be enrolled in this study, you must meet certain requirements. You are eligible to participate if you meet the following criteria:

  • African American or Caucasian females 18-35 years of age
  • BMI 18.5-27.9 kg/m2

 

Study Duration:  up to 6 weeks

Study Commitment:

  • 1 Screening visit
  • 2 Outpatient visits
  • 1 Overnight visit

Study Procedures:

  • Physical exam, vital signs, height, and weight, EKG, fasting labs
  • Waist and Hip measurement
  • IV insertion
  • Multiple blood draws
  • Urine Drug Screen
  • Pregnancy Test
  • DEXA
  • MRI
  • PET
  • Biopsy

Compensation offered up to $ 1,000

This study is being conducted under the direction of Dr. James P. Delany at 301 East Princeton Street, Orlando, Florida 32804.

Microbiome (Nutrition)

Study Status: ACTIVE CURRENTLY ENROLLING

Study Name: Microbiome        

Study Focus:  Nutrition

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact Us form.

Study Purpose:  To collect data to examine how diet impacts the composition and function of the bacteria in your large intestine. This community of bacteria is called the gut microbiome. Recent evidence suggests that these bacteria are important for determining how many of the calories you eat are absorbed. For this and several other reasons studies have shown an association between the bacteria in your large intestine and diseases like obesity and diabetes. Results from this study will improve our understanding of how diet may be able to lead to a healthy gut microbiome.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the associated criteria:

  • Ages 18-45 years old
  • Good general health
  • Weight stable
  • BMI ≤ 30 kg/m2

Study Procedures:

  • Fasting blood draw
  • Urine and stool samples
  • Body composition measurements
  • MRI/MRS (Magnetic Resonance Imaging)
  • DEXA (Dual Energy X-ray Absorptiometry)
  • Whole Room Calorimetry

Study Duration: up to 12 weeks

Study Commitment:

  • 1 screening visit
  • 5 outpatient clinic visits
  • (2) 30-day diet periods
  • (2) overnight stays- 2 nights each
  • (2) overnight stays- 11 nights each

Compensation offered? Yes

This study is being conducted under the direction of Dr. Steven Smith, MD at 301East Princeton Street, Orlando, Florida 32804.

MILE (Fiber and Liver Health)

Study Status: Active-Open to Enrollment

Study Name:  MILE

Study Focus:  Fiber and Liver Health

Study Contact: To learn more, please call 1-877-854-8475 or fill out the Contact us form.

Study Purpose:  To investigate if fiber supplementation (inulin) will lead to a decrease in liver fat.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the following criteria:

  • BMI 25-39.9 kg/m2
  • 18-55 years of age
  • Not diabetic

Study Duration:  approximately 9 weeks

Study Commitment:

  • 1 Screening visit
  • 9 Outpatient visits

Study Procedures:

  • Physical exam, vital signs, height, weight, fasting labs (blood)
  • Urine Drug Screen
  • Pregnancy Test
  • Blood draw
  • DEXA
  • MRI’s

Compensation offered up to $ 620.00

This study is being conducted under the direction of Karen Corbin, PhD at 301 East Princeton Street, Orlando, Florida 32804.

REST (Muscle Mass and Bed Rest)

Study Status: Active-Open to Enrollment

Study Name: REST                         

Study Focus:  Muscle Mass and Bed Rest

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact Us form.

Study Purpose:  To better understand the role of Type 2 Diabetes on skeletal muscle atrophy and recovery following bed rest.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the following criteria:

  • 65 - 80 years of age
  • We are seeking older adults who have been diagnosed with Type 2 Diabetes OR who are health

Study Duration:  up to 14 weeks

Study Commitment:

  • 2 Screening Visits
  • 5 Pre-Bedrest Visits
  • 10 Consecutive Days of Bedrest
  • 8 Weeks of Outpatient Recovery

Study Procedures:

  • Physical exam, vital signs, height/weight/BMI
  • Electrocardiogram (ECG)
  • Lab specimen collection (blood and urine)
  • DEXA and MRI
  • Exercise testing (SPPB, Handgrip Strength, VO2Max)
  • Tissue sampling (muscle)

Compensation offered up to $ 3,550.00

This study is being conducted under the direction of Paul Coen, PhD at 301 East Princeton Street, Orlando, Florida 32804.

SELECT (Cardiovascular Outcomes)

Study Status: Active-Open to Enrollment

Study Name:  SELECT           

Study Focus:  Cardiovascular Outcomes

Study Contact: To learn more, please call 1-877-854-8475 or fill out the Contact us form.

Study PurposeThis study will look at the effect of subcutaneous semaglutide on cardiovascular events in patients who are overweight or obese, and have had a prior heart attack, stroke or diagnosis of peripheral artery disease.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the following criteria:

  • BMI >27 kg/m2
  • >45 years of age, male or female
  • Prior history of cardiovascular disease (prior heart attack, prior stroke, diagnosis of peripheral arterial disease)
  • NO diagnosis of diabetes

Study Duration:  3-5 years

Study Commitment:

  • 1 Screening visit
  • 24 Outpatient visits
  • 1 follow up phone call

Study Procedures:

  • Physical exam, vital signs, height, weight, waist circumference, and blood collection
  • Urine pregnancy (only for females who able to become pregnant)
  • Breast exam (only for females)
  • Questionnaire completion
  • Discussions about healthy lifestyle choices and reducing the risk of cardiovascular events

Compensation offered up to $ 2,675.00

This study is being conducted under the direction of Richard Pratley, MD at 2415 N. Orange Avenue, Suite 501,  Orlando, Florida 32804.

 

TRIA (Investigational Medication)

Study Status: Active-Open to Enrollment 

Study Name:  TRIA    
        
Study Focus:  Investigational Medication                               

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact us form.

Study Purpose:  To evaluate the effects and tolerability of an investigational medication (HM15211) compared to placebo in overweight adults.
    
To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the following criteria:

  • 18 to 65 years of age
  • BMI > 30 kg/m2

Study Duration:  up to 23 weeks 

Study Commitment: 

  • 1 Screening Visit
  • 1 10-day Inpatient Visit
  • 1 5-day Inpatient Visit 
  • 12 Outpatient Visits
  • 1 Follow Up Visit

Study Procedures:

  • Weekly study medication administration (administered as an injection under the skin)
  • Physical exam, vital signs, height/weight/BMI, waist measurement
  • Electrocardiogram (ECG) 
  • Lab specimen collection (blood and urine)
  • MRI (3 total)
  • Fibroscan (Ultrasound)

Compensation offered up to $ 5,200.00 

This study is being conducted under the direction of Dr. Pratley, MD at 301 East Princeton Street, Orlando, Florida 32804.
 

TrialNet (Type 1 Diabetes)

Study Status: Active-Open to Enrollment

Study Name: TrialNet  

Study Focus:  Type 1 Diabetes

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact Us form.

Study Purpose:  To screen relatives of people with type 1 diabetes. They have about 15 times greater risk for developing the disease than people with no family history.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the associated criteria:

  • 1-45 years old and have a brother, sister, child, or parent with type 1 diabetes

OR

  • 1-20 years old and have a cousin, aunt, uncle, niece, nephew, half-brother, half-sister, or grandparent with type 1 diabetes.
    (Your relative has type 1 diabetes if he or she was diagnosed before age 40 and needed insulin injections within a year.)

Study Commitment:

  • A screening visit for blood draw to test for three diabetes autoantibodies
  • Follow-up visits depend on screening visit results
    • If you are negative for those three diabetes autoantibodies you are at low risk for developing diabetes.
    • If you are a positive for a single autoantibody
      • You will come in for a baseline monitoring visit to determine eligibility for annual or semi-annual (every 6 moths) monitoring visits.
    • If you are positive for two or more autoantibodies
      • You will come in for semi-annual (every 6 months) monitoring visits.

Study Procedures:

  • Blood draws for autoantibodies and Hemoglobin A1c
  • Oral Glucose Tolerance Test (OGTT)

Compensation offered? Yes

This study is being conducted under the direction of Dr. Richard Pratley at 301  East Princeton Street, Orlando, Florida 32804.

Past Studies

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1NTERACT (Type 1 Diabetes)

Study Status: CLOSED

Study Name:  1NTERACT                         

Study Focus:  Type 1 Diabetes

Study Contact: To learn more, please call Call407-303-2504 or fill out the Contact Us form.

Study Purpose:  This study is part of a collaborative effort to investigate weight management in young adults with Type 1 Diabetes, and to examine any barriers they may experience with regards to weight management or weight loss.  Also, we are looking to understand the patient perception of managing weight and HbA1c, as it’s suspected that patients feel that weight loss and glucose control are difficult to achieve together.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the following criteria: 

  • Diagnosis of type 1 diabetes for greater than 1 year at screening
  • Males and Females, age 18-25 years, inclusive
  • Hemoglobin A1c of less than 13.0% within the past 6 months
  • Able to provide informed consent

Study Duration: up to 4 weeks (maximum) depending on focus group scheduling

Study Procedures:

  • Read/Understand and signing the Informed Consent
  • Medical History (including HbA1c results, over the last 6 months) reviewed
  • Weight Management and Type 1 Diabetic demographic questionnaire
  • Focus Group sessions

Study Commitment:

  • Attend 1 Screening Visit
  • Attend 1 Focus group session, lasting 2.5 hours, but no longer than 3 hours.
    • There will be separate sessions for males and females. The sessions will be conducted and/or overseen by a registered mental health counselor who specializes in diabetes,  No more than 5 study participants will take part in each group session in order to provide ample time for all participants to engage in the session.  The sessions will be held at the Translational Research Institute at 301 East Princeton Street, Orlando, Florida 32804. 

Compensation offered for completion of both visits: $100.00 gift card.

This study is being conducted under the direction of Richard Pratley, MD at 301 East Princeton Street, Orlando, Florida 32804

A9001498 (Obesity)

Study Status: CLOSED

Study Name:  A9001498      

Study Focus:  Obesity

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact us form.

Study Purpose:  The purpose of this research study is to assess the effect of Liraglutide or placebo administration on food intake in obese subjects.  Liraglutide is a medication that is FDA approved for the treatment of obesity.  

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the following criteria:

  • Healthy, non-diabetic men and women
  • Age 18-75 years, inclusive
  • BMI of 30.0 to 40.0 kg/m2

Study Duration: up to 14 weeks (maximum)

Study Procedures:

  • Physical exam, height, weight, vital signs, EKG, medical history and current medication
  • Blood and urine collections
  • Dual Energy X-ray Absorptiometry (DEXA) to measure body composition
  • Study Drug administration

Study Commitment:

  • 1 Screening visit
  • Total of 6 visits, including 3 outpatient visits and 3 inpatients visits, each inpatient stay consists of 4 days and 3 nights.  Participants will continue to have daily dosing done at the clinic or at their home between visits 3 and 4 and visits 4 and 5. All visits are completed at The Translational Research Institute for Metabolism and Diabetes (TRI-MD).
  • Between the visits mentioned above, daily dosing (either at your home or by traveling into TRI-MD) will occur for a total of approximately 36 days   
  • In addition, there will be follow up contact via phone call, within 28 to 34 days after last dose of the study product.

Compensation offered: up to $4800.00.

This study is being conducted under the direction of Steven Smith, MD at 301 East Princeton Street, Orlando, Florida 32804.

ADORE (Obesity)

Study Status: Closed to Enrollment

Study Name: ADORE

Study Focus: Healthy Obese Subjects

Study Contact: To learn more, please call Call1-877-854-8475 or fill out Contact us form

Study Purpose: To assess the effects of repeated doses of an investigational drug or placebo on energy expenditure and safety in overweight, healthy subjects. 

To be enrolled in this study, you must meet certain requirements.  You are eligible to participate if you meet the following criteria:

  • BMI 28-35
  • 18-45 years of age

Study Duration:  5 to 8 weeks

Study Commitment:

  • 1 Screening Visit
  • Total of 24 Overnight Stays
  • Total of 2 Outpatient Visits
  • Study drug or placebo injection every day for 19 consecutive days
  • 2 series of 3 consecutive 23-hour chamber observation

Study Procedures:

  • Physical exam, vital signs, height and weight, and EKG
  • IV insertion(s)
  • Multiple blood draws
  • Urine Drug Screen
  • Pregnancy Test
  • Dietary Counseling
  • DEXA

Compensation offered up to $5,250

This study is being conducted under the direction of Dr. Steven Smith, at 301 East Princeton Street, Orlando, FL 32804

BATSP (Metabolism and Heart Health)

Study Status: Closed

Study Name: BATSP

Study Focus: Metabolism and Heart Health

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact Us form.

Study Purpose: The purpose of this study is to understand how metabolic and heart health change with aging.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the following criteria:

  • BMI 19-35 kg/m2
  • Age 20-40 and 60-80 years

Study Duration: up to 5 weeks

Study Commitment:

  • 1 Screening visits
  • 2 Outpatient visits

Study Procedures:

  • Medical History review, Physical exams, EKG’s (electrocardiogram) for heart function
  • Bloodwork & pregnancy testing, urinalysis
  • MRI’s & X-rays for body composition, body fat & muscle measurements
  • Nutrition/Exercise monitoring
  • Questionnaires about health status

Compensation offered up to $400

This study is being conducted under the direction of Paul Coen, PhD at 301 East Princeton Street, Orlando, Florida 32804.

Beta Cell T2D (Type 2 Diabetes)

Study Status: CLOSED

Study Name: Beta Cell T2D

Study Focus: Type 2 Diabetes

Study Purpose: The purpose of this study is to better understand how cells that make insulin, known as beta cells, change in response to certain type 2 diabetes medications. Results from this study will help develop therapies to improve beta cell function.    

Study Commitment: The study consists of a total of 4 visits to the TRI-MD facility. The visits include:

  • 1 Screening visit
  • 3 Study visits

Study Duration: up to 10 weeks

Study Qualification: To be enrolled in this study, you must meet certain requirements. You are eligible to participate in one of the following groups if you meet the associated criteria:

  • Type 2 Diabetic Men and Women, aged 30-65
  • BMI 27-40 kg/m2
  • Have been treated with Metformin for at least 8 weeks

Study Procedures:

  • Physical exam
  • Blood and urine collection
  • ECG
  • Oral Glucose Tolerance Test (OGTT)
  • Mixed Meal Tolerance Test (MMTT)
  • Arginine Stimulation Test (AST)
  • Study Medication

Compensation offered? Yes

This study is being conducted under the direction of Dr. Richard Pratley, MD at 301 East Princeton Street, Orlando, Florida 32804.

Study Contact: To learn more, please call Call1-877-854-8475  or fill out the Contact us form.

BIDI (Overweight and Obese with Type II Diabetes)

Study Status: Closed

Study Name:   BIDI  

Study Focus:   Overweight and Obese Individuals with Type II Diabetes

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact us form.

Study Purpose:  To evaluate the effectiveness and safety of an investigational drug, Bimagrumab (study drug) compared to placebo to decrease total body fat mass, increase muscle mass and improve glycemic control in overweight and obese individuals with type 2 diabetes.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the following criteria:

  • BMI 28 - 40
  • 18 - 75 years of age HbA1C between 6.5% - 10%
  • Currently taking only Metformin, only a DPP4 inhibitor, a combination of Metformin and a DPP4 inhibitor, or no anti-diabetes medication at all for  approximately 3 months

Study Duration: Approximately 56 weeks

Study Commitment:

  • 2 Screening visits
  • Total of 16 Outpatient Visits (Study drug or placebo dosing for 12 visits and 3 non-dosing visits) 
  • Total of 12 Phone Calls

Study Procedures:

  • Physical exam, vital signs, height, and weight, EKG
  • DXA and MRI (optional)
  • IV insertion
  • Blood and Urine Collections
  • Dietary Counseling
  • Physical Performance Testing
  • Physical Activity Monitoring
  • Mixed Meal Tolerance Test
  • Compensation offered up to $ 4,400

This study is being conducted under the direction of Dr. Bret Goodpaster, at 301 East Princeton Street, Orlando, Florida 32804.

BirdRock Bio (Patients with Pre-Diabetes)

Study Status:  CLOSED

Study Name:  BIRDROCK BIO  

Study Focus:  Patients with Pre-Diabetes

Type II Diabetes W/ Fatty Liver

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact us form.

Study Purpose:  To evaluate the safety and tolerability of an Investigational drug or placebo administered after 4 weeks of multiple IV dosing in patients with prediabetes or Type II diabetes  with Fatty Liver disease (NAFLD). 

To be enrolled in this study, you must meet certain requirements. You are eligible to participate if you meet the following criteria:

  • Pre-Diabetics or Type II Diabetics, men and women, with Fatty Liver (NAFLD)
  •  Ages 18 – 65

Study Duration:  up to 12 weeks

Study Commitment:

  • 2 Screening visit
  • Total of 7 Overnight Stays
  • Total of 8 Outpatient Visits
  • Study drug or placebo infusions for 30 minutes once per week for 4 weeks

Study Procedures:

  • Physical exam, vital signs, height, and weight, EKG
  • IV insertion
  • Multiple blood draws
  • FibroScan
  • OGTT
  • DNL Procedure
  • MRI
  • Urine Drug Screen
  • Pregnancy Test
  • Dietary Counseling

Compensation offered up to $ 4725.00

This study is being conducted under the direction of Dr. Steven Smith, at 301 East Princeton Street Orlando, Florida 32804

BNP-3 (Metabolism and Obesity)

Study Status: CLOSED

Study Name:   BNP 3

Study Focus:   Metabolism and Obesity

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact us form.

Study Purpose:  To evaluate the safety and tolerability of Nesiritide (study drug) or placebo administered by continuous IV infusion for 48 hours in healthy obese subjects.  

To be enrolled in this study, you must meet certain requirements.  You may eligible to participate if you meet the following criteria:

  • Healthy obese nondiabetic, men and women
  • Ages 40 – 65 years
  • BMI greater than or equal to 30 kg/m2

Study Duration: up to 9 weeks consisting of 5 total visits

Study Commitment:

  • Visit 1 – Screening Visit
  • Visit 2 – 4-day, 3-night inpatient stay  
  • Visit 3 – Follow-up biopsy check
  • Visit 4 – 4-day, 3-night inpatient stay
  • Visit 5 – Follow-up biopsy check

Study Procedures:

  • Medical and medication history
  • Physical Exam, vital signs, height, weight, EKG
  • Dual Energy X-ray Absorptiometry (DEXA) to measure body composition
  • IV insertion for study drug or placebo infusion and blood draws
  • Resting Metabolic Rate (RMR) Measurement
  • Muscle Tissue and Adipose (Fat) Biopsies

Compensation offered? Yes $1,250.00

This study is being conducted under the direction of Dr. Pratley, at 301 East Princeton Street, Orlando, Florida 32804. 

 

EIFFEL2.0 (Metabolism)

Study Status: CLOSED

Study Name: EIFFEL 2.0

Study Focus: Metabolism

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact us form.

Study Purpose:  To collect data to help researchers better understand the different ways that women or men store fat (apple shape versus pear shape). Data suggest that fat in the lower body (pear shape) prevents the development of diabetes or the increase of cardiovascular risk associated with overweight or obesity. Understanding the origin of the fat distribution may help to understand several common chronic diseases such as diabetes and cardiovascular disease (CVD).

To be enrolled in this study, you must meet certain requirements. You are eligible to participate in one of the following groups if you meet the associated criteria:

  • Healthy, non-diabetic men and women
  • Ages 18-45 years old
  • BMI: 23-35 kg/m2
  • Weight stable (no change in weight in the last three months greater than or equal to 6 lbs)

Study Duration:  up to 4 weeks

Study Commitment: The study consists of a total of 4 visits to the TRI-MD facility. The visits include:

  • 1 Screening visit
  • 3 Study visits

Study Procedures:

  • Physical exam
  • blood and fat tissue collection
  • MRS Scan
  • Dual Energy X-ray Absorptiometry (DEXA) to measure body composition
  • Resting Metabolic Rate
  • Intravenous glucose tolerance test

Compensation offered? Yes

This study is being conducted under the direction of Dr. Steven Smith, MD at 301East Princeton Street, Orlando, Florida 32804.

ENHANCE (Alzheimer's Disease)

Study Status: Closed to Enrollment

Study Name: ENHANCE

Study Focus: Alzheimer’s disease

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact us form.

Study Purpose: The purpose of this study is to acquire a greater understanding of Alzheimer disease (AD). The exact pathology of AD is currently unknown. Previous research has suggested that certain abnormalities that can be found in analysis of blood are associated with the increased risk of AD.  We hope this research will promote the detection of new biomarkers that may lead to prevention, earlier diagnosis, and more effective treatments.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the following criteria:

  • New diagnoses of  Mild- Moderate Alzheimer’s disease
  • Must be at least 60 years old
  • Participant cannot be diagnosed with any chronic conditions including: diabetes (sugar problems) and heart condition 

Study Duration:  up to 4 weeks

Study Commitment: The study consists of a total of 3 visits to the TRI-MD facility. The visits include:

  • 1 Screening visit
  • 1 Study visit (MRI , DEXA & blood collection)
  • 1 Follow-up visit (discussion of clinical findings with participant)

Study Procedures:        

  • Cognitive and depression assessment
  • Blood collection
  • Brain Imaging MRI         
  • Dual Energy X-ray Absorptiometry (DEXA) to measure body composition

Compensation offered? Yes

This study is being conducted under the direction of Dr. Steven Smith, MD at 301 East Princeton Street, Orlando, Florida 32804. 

GIO B (Obesity)

Study Status: CLOSED

Study Name: GIO-B

Study Focus:   Obesity

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact us form.

Study Purpose:  Is to assess the effects of a continuous infusion (over 72 hours) of glucagon (FDA approved, however the dosage of the glucagon has not been FDA approved) to measure energy in Healthy Obese Subjects.  The current study is to measure energy while you are resting, sleeping and exercising in our Metabolic chamber (a special room where we measure energy).

To be enrolled in this study, you must meet certain requirements. You are eligible to participate in one of the following groups if you meet the associated criteria:

  • Healthy, men and women without diabetes
  • Ages 18 – 55
  • BMI greater than or equal to 27 and Less than or equal to 45 kg/m2 and body weight < 450 lbs

Study Duration:  up to 5 weeks

Study Commitment: The study consists of 2 outpatient visits, 6 Inpatient days and 1 follow up visit.

  • 1 Screening visit
  • 1 Outpatient visit Study Day -5, Inpatient visit Study Day -2 thru Study Day 4 (approx.6 days), follow up visit 2-5 days after discharge from the CRU.

Study Procedures:

  • Physical exam, vital signs, height, and weight
  • IV insertion for Glucagon infusion and blood draws
  • Dual Energy X-ray Absorptiometry (DEXA) to measure body composition
  • Metabolic chamber (special room where we measure energy)
  • Questionnaires

Compensation offered? Yes

This study is being conducted under the direction of Dr. Steven Smith, at 301 East Princeton Street, Orlando, Florida 32804.

InvestiGAIT (Aging)

Study Status: CLOSED

Study Name: InvestiGAIT

Study Focus: Aging

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact us form.

Study Purpose: The purpose of this study is to find out if the drug bimagrumab (BYM338) is safe and has beneficial (positive) effects in people with a lower than normal amount of muscle, as compared to placebo. To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the associated criteria:

  • 70 years old or older
  • Weight of at least 77 lbs
  • BMI 15-32 kg/m2
  • Self-reported mobility limitations, for example; difficulty walking, rising from a chair, or climbing stairs.

Study Duration: up to 10 months

Study Commitment: The study consists of about 13 visits to the TRI-MD facility. The visits include:

  • 1 Screening visit
  • At least 12 Study visits

During the study, some of the procedures will include:

  • Physical exam
  • Blood collection
  • ECG (Electrocardiogram)
  • Physical function and strength tests
  • DEXA (Dual-Energy Xray Absorptiometry)
  • Study drug/Placebo IV infusion

Compensation offered? Yes This study is being conducted under the direction of Dr. Bret Goodpaster, at 301 East Princeton Street, Orlando, Florida 32804.

ISTARmicro (Artificial Sweeteners)

Study Status: CLOSED

Study Name: ISTARmicro

Study Focus: Artificial Sweeteners

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact us form.

Study Purpose: The purpose of this study is to collect data to examine whether short-term consumption of non-caloric artificial sweeteners (NCASs), such as saccharin, can lead to changes in your blood sugar levels and in the composition of the bacteria in your large intestine. The community of intestinal bacteria is called the gut microbiota. Several studies have shown an association between gut microbiota and diseases like obesity and diabetes. Your intestine also carries some specialized receptors for sensing sweet nutrients, such as sugars and NCASs. These sensors are called sweet taste receptors (STRs) which are also found on your tongue, allowing you to taste the "sweetness" of the food you consume. This study will improve our understanding on how NCASs may be able to modify your gut microbiota and blood sugar and whether blocking the function of STRs can prevent these changes.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the associated criteria:

  • BMI ≤25 kg/m2
  • Stable weight
  • Age: 18-45 years old
  • Good general health
  • Do not use non-caloric artificial sweeteners

Study Procedures:

  • Blood draw
  • Urine and stool collection
  • Physical exam
  • Consumption of non-caloric artificial sweeteners

Study Commitment: up to 6 weeks

Total of 4 visits (1 screening visit and 3 outpatient visits)

Compensation offered? Yes

This study is being conducted under the direction of Dr. George Kyriazis, at 301 East Princeton Street, Orlando, Florida 32804.

MicroG (Exercise and Muscle)

Study Status: Closed

Study Name: microG

Study Focus: Exercise and Muscle

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact Us form.

Study Purpose: To obtain a better understanding of the body’s responses to physical inactivity due to microgravity and muscle contractions, that may help explain health benefits of exercise.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the following criteria:

  • BMI <30 kg/m2
  • 20-40 and 60-80 years of age

Study Duration: up to 5 weeks

Study Commitment:

  • 1 Screening visit
  • 2 Outpatient visits
  • 1 follow up phone call

Study Procedures:

  • Physical exam, vital signs, height, weight, waist circumference, ECG, fasting labs (blood and urine)
  • Urine Drug Screen
  • Pregnancy Test
  • DEXA
  • VO2Max
  • SPPB
  • Muscle Testing
  • Handgrip Strength Testing
  • Blood draw
  • Muscle biopsy

Compensation offered up to $400.00

This study is being conducted under the direction of Paul Coen, PhD at 301 East Princeton Street, Orlando, Florida 32804.

Mirage (Exercise in the Aging)

Study Status: CLOSED

Study Name:  MIRAGE

Study Focus:   Exercise in the aging

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact us form.

Study Purpose: The purpose of this study is to collect data to help researchers understand how diet and exercise may affect certain body processes (fat metabolism and insulin resistance) which lead to the development of type 2 diabetes.

Study Commitment:

  • 1 screening visit,
  • 5 study visits,
  • 2 overnight visits,
  • and a 6 month participation in one of the following three groups (you will be randomly assigned): 
    • 1. Physical activity plus dietary intervention
    • 2. Dietary intervention program
    • 3. Health education program

Study Duration:  Approximately 8 to 10 months

Study Qualifications: Men and Women aged 60-80, with or without diabetes (type 2), stable weight, (No Gain/Loss of > 10 lbs in 6 months), sedentary, non-smoker, and Body Mass Index (BMI)  ≥ 30 kg/m2

Study Procedures:

  • Physical ExamEKG (heart tracing)
  • Blood, urine, and tissue collection (including muscle and fat biopsy)
  • Muscle strength and balance testing
  • Dual Energy X-ray Absorptiometry (DEXA) scan to measure body composition
  • Magnetic Resonance Spectroscopy (MRS) scans
  • Resting Metabolic Rate (RMR) measurement

*Study requires 2 overnight stays at the TRI-MD facility

Compensation offered? Yes

This study is being conducted under the direction of Bret Goodpaster, PhD at 301 East Princeton Street, Orlando, Florida 32804.

Pioneer 5 (Type 2 Diabetes with Kidney Impairment)

Study Status: CLOSED

Study Name: Pioneer 5                            

Study Focus:  Type 2 Diabetes with Kidney Impairment

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact us form.

Study Purpose: To compare the effect of once-daily dosing of 14 mg oral semaglutide versus placebo,  in combination with metformin and/or sulfonylurea, basal insulin alone or metformin in combination with basal insulin in subjects with type 2 diabetes mellitus and moderate kidney impairment.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the following criteria:

  • Men or women diagnosed with Type 2 Diabetes, with kidney impairment
  • Taking a stable dose of Metformin and/or a Sulfonylurea,  Basal Insulin alone or Metformin in combination with basal insulin.
  • Hemoglobin A1c measurement between 7.0-9.5%
  • Male or Females at the age of 18 and older.

Study Duration: up to 33 weeks (maximum)

Study Procedures:

  • Physical exam, height, weight, vital signs, EKG, medical history and current medications
  • Blood and urine collections
  • Questionnaires, eye exam, collection of glucose diaries
  • Study Drug administration

Study Commitment:

  • Total of 8 clinic visits, including a screening visit
  • In addition 1- 6 phone calls depending what medications you are on over the 33 weeks.

All visits are completed at The Florida Hospital Diabetes Institute, 2415 North Orange Ave., Suite 501, Orlando Florida 32804.  

Compensation offered?: Yes, up to $715

This study is being conducted under the direction of Richard Pratley, MD at 301 East Princeton Street, Orlando, Florida 32804.

Prevail (Obesity and Type 2 Diabetes)

Study Status: Closed

Study Name: PREVAIL                            

Study Focus: Obesity and Type 2 Diabetes   

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact Us form.

Study Purpose: To assess the effects of an investigational drug compared to placebo in severely obese Type 2 subjects. 

To be enrolled in this study, you must meet certain requirements. You are eligible to participate if you meet the following criteria: 

  • Type II Diabetes
  • Ages 18-70
  • BMI 35-50
  • Stable Weight  
  • A1C 6.5-9.5%

Study Duration:   19 weeks   

Study Commitment: 

  • 8 Outpatient Visits
  • 2 Phone Calls

Study Procedures: 

  • Physical exam, vital signs, height, and weight, measurement of waist circumference
  • ECG
  • Multiple blood draws and urine collection
  • Pregnancy Test

Compensation: Stipend for time and travel up to $ 440.00

This study is being conducted under the direction of Dr. Richard Pratley, at 2415 N. Orange Ave Suite 501 Orlando, Florida 32804.

Sarcopenia (Exercise and Muscle Metabolism)

Study Status: CLOSED

Study Name: Sarcopenia

Study Focus: Exercise and Muscle Metabolism

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact us form.

Study Purpose:  The purpose of this study is to examine how physical activity alters the metabolism of your muscle in order to improve muscle size and function, particularly in individuals with low muscle mass and strength.  This study should provide new information concerning the processes associated with the gradual loss of muscle that occurs in aging adults, known as Sarcopenia.  This is important because Sarcopenia affects a lot of older individuals and can cause a number of health issues. Ultimately this may help identify physiological mechanisms responsible for the development of Sarcopenia.         

Study Commitment for group 1

  • 2 screening visits
  • 1 exercise visit

Study Duration:  up to 4 weeks

Study Qualifications for cohort 1: 21-40 years of age, stable weight (no Gain/loss of > 10 lbs in 6 months), have been training for endurance competition (running, cycling) for at least 5 years without an extensive layoff (>6 months) due to injury.

Study Qualifications for cohort 2: 65-90 years of age, stable weight (no Gain/Loss of > 10 lbs in 6 months), have been exercise training for competition for at least 5 years without an extensive layoff (>6 months) due to injury.

Study Qualifications for cohort 3: 65-90 years of age, stable weight (No Gain/Loss of > 10 lbs in 6 months), sedentary (≤ 1 continuous exercise/week), BMI < 35 kg/m2.

Compensation offered? Yes

This study is being conducted under the direction of Paul Coen, PhD at 301 East Princeton Street, Orlando, Florida 32804.

T1DIL-21 (Type 1 Diabetes)

Study Status: CLOSED

Study Name: T1DIL-21

Study Focus: Type 1 Diabetes

Study Contact: To learn more, please call Call1-877-854-8475 or fill out the Contact us form.

Study Purpose: To determine if a combination of an investigational drug called anti-IL-21 (NNC0114-0006) and a drug marketed for type 2 diabetes, called liraglutide, in addition to your standard treatment prescribed by your doctor, is able to preserve the function of insulin-producing cells in the pancreas.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the associated criteria:

  • Newly diagnosed with type 1 diabetes, within the last 20 weeks
  • 18-45 years old
  • Men and women
  • BMI ≥18.5 kg/m2

Study Procedures:

  • Fasting blood draw
  • Physical exam
  • Vital signs and blood pressure
  • Electrocardiogram (ECG)
  • Mixed Meal Tolerance Test (MMTT)
  • Questionnaires

Study Duration: up to 20 months

Study Commitment:

  • 2 screening visit
  • 1 randomization visit
  • 25 clinic visits
  • 61 phone calls

Compensation offered? Yes

This study is being conducted under the direction of Dr. Richard Pratley, MD at 301 East Princeton Street, Orlando, Florida 32804.

W1SDM (Type 1 Diabetes)

Study Status: Closed to Enrollment

Study Name: W1SDM  

Study Focus:   Type 1 Diabetes

Study Contact: To learn more, please call Call407-303-2504  or fill out the Contact us form.

Study Purpose:  To determine if CGM (FDA approved device that provides continuous insight into glucose levels) can reduce hypoglycemia and improve quality of life in older adults with Type 1 diabetes. 

To be enrolled in this study, you must meet certain requirements. You are eligible to participate in one of the following groups if you meet the associated criteria:

  • Diagnosed with Type 1 Diabetes
  • Age ≥ 60
  • Utilize insulin pump or multiple daily insulin injections
  • HbA1c < 10%

Study Duration: 26 weeks

Study Commitment:

  • The study consists of 1 screening visit
  • 9 outpatient visits

Study Procedures:

  • Physical exam, vital signs, height, and weight
  • Assessments
  • Questionnaires

Compensation offered: Yes up to $525.00

This study is being conducted under the direction of Dr. Richard Pratley, at 301 East Princeton Street, Orlando, Florida 32804.

Research Volunteers

Research volunteers are essential to the TRI's success. The key to making breakthroughs in medicine and discovering the cures for diseases related to metabolism and diabetes lies in you!   

Becoming a research volunteer in a TRI research study allows you to learn more about your body, while helping researchers learn more about why and how diseases affect different people.   We invite all adults, 18 and older, to join our effort to Innovate, Discover, Cure. 

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Become a Participant

The screening/enrollment process begins here.  When you complete the Contact Us form, a member of the study team will contact you within 1 business day.  

What to Expect

Although we are looking for as many volunteers as possible, not everyone will qualify as a TRI research volunteer.  We follow a thorough screening/enrollment process to protect our volunteer’s health and safety.

After completing an initial screening questionnaire with a member of the study team, you will be matched with the study that is right for you.  You will be invited to come to the TRI facility to read the Informed Consent Form and discuss your participation with members of the study team. The Informed Consent Form is a document that describes the rights of a study participant and provides details about the study, such as its purpose, duration, required procedures, risks, potential benefits, and key contacts.   Your participation in the study will begin after you have been informed of all aspects of the study that are relevant to your decision to take part, you have had all of your questions answered to your satisfaction, and you have confirmed your willingness to participate, in writing, by signing and dating the Informed Consent Form. 

Your participation will begin with a screening visit that will include procedures and tests that will determine if you are eligible to participate in the remainder of the study.  Common screening procedures and tests include, but are not limited to:

  • Medical history and medication review
  • Vital sign measurements
  • Physical examination
  • Electrocardiogram (EKG)
  • Blood and urine collection for testing

If you meet all study eligibility criteria, you will be enrolled in the study.  You will be scheduled to return to the facility for a pre-determined number of study visits over a specific period of time.  During these visits, you will complete study-related procedures and tests, which may include:

  • Current health status and medication review
  • Vital sign measurements
  • Physical examination
  • Blood and urine collection for testing
  • Tissue collection for testing
  • Dual Energy X-ray Absorptiometry (DEXA) scan for body composition measurement
  • Resting Metabolic Rate (RMR) measurement
  • Exercise testing for VO2 max measurement

You may also be asked to complete study-related tasks at home, such as wearing an activity monitor, measuring and documenting your blood glucose levels, following a specific diet, or taking an investigational medication.  Additionally, many studies offer compensation for time and travel.

Volunteer's Bill of Rights

As a research volunteer, you have certain rights.  We, at the TRI, are dedicated to respecting these rights.

  • To be told the purpose of the study
  • To be told what will happen to you if you take part in the study and whether any procedures, drugs, or devices are different than those that are used in standard medical treatment.
  • To be told about all the risks, side effects, or discomforts of the things that will happen to you for research purposes
  • To be told if you can expect any benefit from participating, and if so, what the benefit might be
  • To be told about all options available to you and how they are better or worse than being in a research study
  • To be allowed to ask any questions about the study before signing the consent and/or at any time during the course of the study
  • To be allowed ample time, without pressure, to decide whether or not to consent to participate
  • To be assured that study records will remain confidential to the extent allowed by law
  • To be told what compensation you will receive and what charges you will pay
  • To be told what sort of medical treatment is available if any complications arise
  • To be told about any new findings that may affect your willingness to continue participating in the study
  • To refuse to participate or to change your mind about participating after the study has started, without penalty
  • To receive a signed and dated copy of the Informed Consent Form

Meet Our Team

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Steven R. Smith, MD

Scientific Director

Bret H. Goodpaster, PhD

Senior Investigator 

Richard E. Pratley, MD

Senior Investigator 

Paul M. Coen, PhD

Investigator

Heather Cornnell, PhD

Senior Research Scientist - Imaging

Elvis Alvarez Carnero, PhD

Postdoctoral Fellow

Adeline Divoux, PhD

Postdoctoral Fellow

Maria F. Pino, PhD

Postdoctoral Fellow 

 

Robert Standley, PhD

Postdoctoral Fellow 

Who We Are

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Mission

To extend and improve the quality of lives through the conduct of world-class, innovative translational research that leads to discoveries - and ultimately cures – for obesity, diabetes and cardiovascular diseases.

Vision
With diligent respect to the culture, values and competencies of each organization, and those organizations we serve, the Translational Research Institute for Metabolism and Diabetes will develop and conduct world-class translational research addressing diabetes, obesity and the metabolic origins of cardiovascular disease.

Values

  • Scientific Advancement
    Our dedication to scientific advancement in the development of predictive biomarkers application through translational research will revolutionize healthcare delivery.
  • Collaboration
    Deliberate and strategic collaboration across the disciplines of science, healthcare, academics and business will create a translational research platform that impacts medicine and society.
  • Integrity
    Integrity in all aspects of our work and business is at the heart of all we do.
  • Ethical Treatment
    Ethical treatment for persons and society will guide our applications of all research.
  • National and International Recognition
    The level of research conducted will broaden the reach and identity of the Institute to achieve national and international recognition.
  • Center of Excellence
    The partnership of Florida Hospital and Sanford-Burnham Medical Research Institute shall be recognized as a center of excellence for translational research throughout the scientific, academic, industry and medical community.
  • Education
    Education of physicians, scientists, healthcare providers, industry and society is an imperative for the mission. 
Partners

The Translational Research Institute for Metabolism and Diabetes (TRI) is the product of an innovative affiliation between AdventHealth and Sanford-Burnham Medical Research Institute that bridges the gap between discovery research and clinical care. The TRI brings together the complementary strengths of Sanford-Burnham’s basic science prowess and advanced research technologies and AdventHealth’s compassionate, comprehensive clinical care and clinical/translational research expertise to accelerate the discovery and development of new approaches to diagnose, treat, and prevent obesity, diabetes, and their cardiovascular complications.

  • AdventHealth
    Since 1908, AdventHealth has cared for the health of Central Floridians. What began on the shores of Lake Estelle in Orlando, has grown into seven hospitals and 19 Centra Care locations throughout Central Florida, treating more patients that any other hospital system in the country. 
  • Sanford Burnham Prebys Medical Discovery Institute at Lake Nona
    Sanford Burnham Prebys Medical Discovery Institute is dedicated to discovering the fundamental molecular causes of disease and devising the innovative therapies of tomorrow.
  • AdventHealth Diabetes Institute
    As one of the largest and most comprehensive diabetes and endocrine centers in the country, the AdventHealth Diabetes Institute (AHDI) treats over 30,000 patients per year with a holistic approach that provides patients the necessary care and knowledge to effectively manage their diabetes.
  • TRI Scientific Advisory Board (SAB)
    The SAB is a group of independent translational scientists, expert in the areas of metabolism and diabetes, who provide guidance and advice on the TRI's scientific and clinical directions.

Our Location

  • About Us:

    Established in August 2009, the Translational Research Institute for Metabolism and Diabetes is a joint venture between AdventHealth and Sanford-Burnham Medical Research Institute that is dedicated to the study of obesity, metabolism, diabetes, and the metabolic origins of cardiovascular disease.