Isoleucine Intake and Intermediary Metabolism in Type 2 Diabetes
Completed · Not applicable · Has a placebo group
Conditions studied: Type 2 Diabetes
In brief
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 insulin resistant T2D. We will test the hypotheses that isoleucine and valine oxidation to propionyl CoA is reduced and that week long oral administration of isoleucine in T2D subjects will increase propionyl CoA and succinyl CoA production in muscle. The secondary objectives of this study are to determine the extent to which type 2 diabetics are capable of controlling and coordinating complex patterns of force using the upper and lower limb. This line of research has functional significance as upper body coordination and fine motor control is important for many activities associated with daily living and may contribute to therapy protocols for individuals with type 2 diabetes. Functional performance via six-minute walk and balance board measurement will also be tested with and without sensory augmentation via electrical stimulation of foot. Changes in peripheral blood mononuclear cells (PBMCs) mitochondrial respiration values will also be assessed between subject types and for diabetic after the 10-day supplementation period.
Key facts
- Study ID
- NCT04461236
- Run by
- Texas A&M University
- People needed
- 38
- Starts
- 2019-05-30
- Expected to finish
- 2020-03-02
- Last updated by the study team
- 2025-02-03
Who can join
Age: 45 and older, up to 84. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Texas A&M University CTRAL — College Station, Texas, United States
Full record on ClinicalTrials.gov
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