CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 38 enrolled
Drug / intervention
Oral Supplement +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04461236
NCT04461236N/ACompleted

Isoleucine Intake and Intermediary Metabolism in Type 2 Diabetes

Texas A&M University·interventional·Posted Jul 8, 2020·Updated Feb 3, 2025

In Brief

A clinical study evaluating Oral Supplement and Placebo for Type 2 Diabetes. Completed, enrolled 38 participants across 1 site.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 8, 2020
Enrollment StartMay 30, 2019
Primary CompletionMar 2, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 6.0 years ago

Interventions

Oral Supplementdietary

Supplement provided in capsules. Half the capsules to be taken with lunch and the other half with dinner. All supplements are commercially available.

Placebodietary

Placebo