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

Inclusion criteria

• 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 criteria

• 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