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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 32

Inclusion Criteria

Males and females, 19 to 30 years of age, inclusive.
Type 1 Diabetes Cohort:
1. Diagnosis of type 1 diabetes for greater than 1 year at screening.
2. 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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Energy Expenditure	24 hours	Measured via whole room calorimetry; based on oxygen consumption and carbon dioxide production measured using gas analyzers, as well as 14-hour urinary nitrogen excretion; calculated using established equations.

Secondary Outcome Measures