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NCT04461236 · ClinicalTrials.gov registry record · NA
Isoleucine Intake and Intermediary Metabolism in Type 2 Diabetes
A NA study, sponsored by Texas A&M University.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT04461236: Completed NA study, sponsored by Texas A&M University.
NCT04461236 is a NA study that has completed, run by Texas A&M University. The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04461236, a NA study, has completed, sponsored by Texas A&M University.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study 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.
Primary Outcome
Change in whole-body protein synthesis rate after 10 days of isoleucine supplementation
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Oral Supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2019-05-30 |
| Est. Completion | 2020-03-02 |
| Phase | NA |
What the finished NCT04461236 record still lists
NCT04461236 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04461236 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04461236 about?
NCT04461236 is a clinical study titled "Isoleucine Intake and Intermediary Metabolism in Type 2 Diabetes". 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 C...
What is the current status of trial NCT04461236?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2019-05-30. Estimated completion is 2020-03-02.
What interventions are being tested in trial NCT04461236?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Oral Supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04461236?
This trial is sponsored by Texas A&M University, which has 95 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04461236's enrollment target sits among peer trials
38 1538th of 2000 higher than 461 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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