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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 is a NA study that has completed, run by Texas A&M University. The registered enrollment target is 38 participants.

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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.

Interventions

  • DIETARY_SUPPLEMENT Placebo
  • DIETARY_SUPPLEMENT Oral Supplement

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2019-05-30
Est. Completion 2020-03-02
Phase NA

Sponsor

Texas A&M University

95 total trials

What the Registry Record Tells You About NCT04461236

The ClinicalTrials.gov registry entry for NCT04461236 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Texas A&M University, which has 95 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04461236 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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