Status:
COMPLETED
Isoleucine Intake and Intermediary Metabolism in Type 2 Diabetes
Lead Sponsor:
Texas A&M University
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
45-84 years
Phase:
NA
Brief Summary
The primary objective of this study is to determine the mechanism of reduced branched-chain amino acid (BCAA) oxidation to propionyl CoA and isoleucine intake can affect TCA cycle function in obese in...
Detailed Description
Defects in mitochondrial β-oxidation and branched chain amino acid (BCAA) oxidation are associated with type 2 diabetes (T2D) and other conditions such as Huntington's disease and maple syrup urine di...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age: 45-84 years old, inclusive
- Clinical diagnosis with type-II diabetes (Diabetics subjects only) and oral glucose lowering medication or insulin
- Stable body-weight (± 5%) for the past 3 months
- Body Mass Index (BMI): 28 kg/m2 or higher
- Subject is judged to be in satisfactory health based on medical history, physical examination, and laboratory screening evaluations.
- Ability to walk, sit down and stand up independently
- Ability to lie in supine or elevated position for up to 10 hours
- Willingness and ability to comply with the protocol
- Exclusion criteria:
- Subject is expected to have surgery within one-month of screening
- Subject is currently participating or has participated in a study with an investigational compound or device within 30 days of signing the informed consent.
- Active dependence of alcohol or drugs
- Diagnosed and active treatment of Type 1 Diabetes Mellitus
- Medication: Use of substances known to influence protein metabolism: antibiotics within 3 weeks prior to the study visit, current use of corticosteroids, growth hormone, testosterone, estrogen, immunosuppressant, blood thinners, or insulin.
- Adherence to a weight loss diet.
- (Possible) pregnancy
Exclusion
Key Trial Info
Start Date :
May 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2020
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04461236
Start Date
May 30 2019
End Date
March 2 2020
Last Update
February 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Texas A&M University CTRAL
College Station, Texas, United States, 77845-4253