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N/A N=32

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

Type 1 Diabetes

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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