The Influence of Glycemic Control and Obesity on Energy Balance and Metabolic Flexibility in Type 1 Diabetes



Status:Recruiting
Conditions:Obesity Weight Loss, Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:19 - 39
Updated:2/17/2019
Start Date:March 8, 2018
End Date:November 2019
Contact:Recruitment Department
Email:tri@flhosp.org
Phone:407-303-7100

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The purpose of this study is to compare the metabolic phenotype of a range of body weights in
individuals with and without Type 1 diabetes.


Inclusion Criteria:

1. Males and females, 19 to 30 years of age, inclusive.

2. Type 1 Diabetes Cohort:

- Diagnosis of type 1 diabetes for greater than 1 year at screening.

- Hemoglobin A1c 6.5-13% or

3. Non-Diabetic Control Cohort:

- Healthy individuals (non-diabetic) matched to T1D cohort by BMI, and gender

3. Able to provide informed consent. 4. BMI 18-39

Exclusion Criteria:

1. Type 2 diabetes

2. History or presence of cardiovascular disease (unstable angina, myocardial infarction
or coronary revascularization within 6 months, clinically significant abnormalities on
EKG, presence of cardiac pacemaker, implanted cardiac defibrillator)

3. Liver disease (AST or ALT >2.5 times the upper limit of normal), history of hepatitis

4. Kidney disease (creatinine >1.6 mg/dl or estimated glomerular filtration rate (GFR)<60
ml/min)

5. Dyslipidemia, including triglycerides >800 mg/dl, LDL >200 mg/dl

6. Anemia (hemoglobin <12 g/dl in men, <11 g/dl in women)

7. Thyroid dysfunction (suppressed thyroid-stimulating hormone (TSH), elevated TSH <10
µIU/ml if symptomatic or elevated TSH >10 µIU/ml if asymptomatic)

8. Uncontrolled hypertension (BP >160 mmHg systolic or > 100mmHg diastolic)

9. History of cancer within the last 5 years (skin cancers, with the exception of
melanoma, may be acceptable).

10. Initiation or change in hormone replacement therapy within the past 3 months
(including, but not limited to thyroid hormone, birth control or estrogen replacement
therapy)

11. History of organ transplant

12. History of HIV, active Hepatitis B or C, or Tuberculosis

13. Pregnancy, lactation or 6 months postpartum from screening visit

14. History of major depression

15. Psychiatric disease prohibiting adherence to study protocol

16. History of eating disorders

17. Cushing's disease or syndrome

18. History of bariatric surgery

19. Tobacco use within the past 3 months

20. History of drug or alcohol abuse (≥3 drinks per day) within the last 5 years

21. Use of oral or injectable anti-hyperglycemic agents (except insulin)

22. Current use of beta-adrenergic blocking agents

23. Use of antibiotics within the past 3 months

24. Weight >450 lbs (This is DEXA table weight limit)

25. Metal implants (pace-maker, aneurysm clips) based on Investigator's judgment at
screening

26. Unable to participate in MRI or magnetic resonance spectroscopy (MRS) assessment based
on Investigator's judgment at screening

27. Participants with strict dietary concerns (e.g. vegetarian or kosher diet, multiple
food allergies, or allergies to food we will provide them during the study)

28. Gastrointestinal disorders including: inflammatory bowel disease or malabsorption,
swallowing disorders, suspected or known strictures, fistulas or
physiological/mechanical GI obstruction, history of gastrointestinal surgery, Crohn's
disease or diverticulitis.

29. Presence of any condition that, in the opinion of the investigator, compromises
participant safety or data integrity or the participant's ability to complete study
visits
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Orlando, Florida 32804
Phone: 407-303-7100
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