Status:
COMPLETED
The Influence of Glycemic Control and Obesity on Energy Balance and Metabolic Flexibility in Type 1 Diabetes
Lead Sponsor:
AdventHealth Translational Research Institute
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
19-30 years
Brief Summary
The purpose of this study is to measure the metabolic phenotype of a range of body weights in individuals with and without type 1 diabetes.
Eligibility Criteria
Inclusion
- Males and females, 19 to 30 years of age, inclusive.
- Type 1 Diabetes Cohort:
- Diagnosis of type 1 diabetes for greater than 1 year at screening.
- Hemoglobin A1c 6.5-13% or
- Control Cohort Without Diabetes:
- a. Healthy individuals without diabetes matched to T1D cohort by BMI and gender
- Able to provide informed consent.
- BMI 18-39.9 kg/m\^2
Exclusion
- Type 2 diabetes
- 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)
- Liver disease (AST or ALT \>2.5 times the upper limit of normal), history of hepatitis
- Kidney disease (creatinine \>1.6 mg/dl or estimated glomerular filtration rate (GFR)\<60 ml/min)
- Dyslipidemia, including triglycerides \>800 mg/dl, LDL \>200 mg/dl
- Anemia (hemoglobin \<12 g/dl in men, \<11 g/dl in women)
- Thyroid dysfunction (suppressed thyroid-stimulating hormone (TSH), elevated TSH \<10 µIU/ml if symptomatic or elevated TSH \>10 µIU/ml if asymptomatic)
- Uncontrolled hypertension (BP \>160 mmHg systolic or \> 100mmHg diastolic)
- History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable).
- 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)
- History of organ transplant
- History of HIV, active Hepatitis B or C, or Tuberculosis
- Pregnancy, lactation or 6 months postpartum from screening visit
- History of major depression
- Psychiatric disease prohibiting adherence to study protocol
- History of eating disorders
- Cushing's disease or syndrome
- History of bariatric surgery
- Tobacco use within the past 3 months
- History of drug or alcohol abuse (≥3 drinks per day) within the last 5 years
- Use of oral or injectable anti-hyperglycemic agents (except insulin)
- Current use of beta-adrenergic blocking agents
- Use of antibiotics within the past 3 months
- Weight \>450 lbs (This is DEXA table weight limit)
- Metal implants (pace-maker, aneurysm clips) based on Investigator's judgment at screening
- Unable to participate in MRI or magnetic resonance spectroscopy (MRS) assessment based on Investigator's judgment at screening
- 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)
- 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.
- 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
Key Trial Info
Start Date :
March 8 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 20 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03379792
Start Date
March 8 2018
End Date
July 20 2020
Last Update
January 5 2024
Active Locations (1)
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1
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States, 32804