N/A
N=32
The Influence of Glycemic Control and Obesity on Energy Balance and Metabolic Flexibility in Type 1 Diabetes
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03379792 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Energy Expenditure — 1978.3; 1969.8; 2414.8; 1497.7 Kilocalories — p=0.24
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 19+ yrs
- Sex
- All
- Sponsor
- AdventHealth Translational Research Institute
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Energy Expenditure |
1978.3; 1969.8; 2414.8; 1497.7; 1902.0; 2671.3 | 0.24 |
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 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) 800 mg/dl, LDL >200 mg/dl
- Anemia (hemoglobin 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
Data sourced from ClinicalTrials.gov (NCT03379792). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.