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

AdventHealth Translational Research Institute1 site in 1 country32 target enrollmentMarch 8, 2018

ConditionsType 1 Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 1 Diabetes
Sponsor: AdventHealth Translational Research Institute
Enrollment: 32
Locations: 1
Primary Endpoint: Energy Expenditure
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 8, 2018

End Date

July 20, 2020

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AdventHealth Translational Research Institute

Responsible Party

Sponsor

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)\<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)

Outcomes

Primary Outcomes

Energy Expenditure

Time Frame: 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.