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Role of BCAA in Glucose Homeostasis

NCT05836350 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-05-01

No results posted yet for this study

Summary

This clinical trial study aims to evaluate the effects of prolonged NaPB treatment in a maximum of 20 patients with T2D. The primary objective is:

to investigate if prolonged boosting of ing BCAA oxidation will substantially lower plasma glucose levels in patients with T2D.

Participants will undergo a Clinical randomized controlled trial (RCT) with a double-blinded, placebo-controlled, cross-over design, including a wash-out period of 12 weeks. The trial will contain 2 treatment arms, with each a duration of 12 weeks.

Participants will have a 12-week oral administration of 4.8 g/m2/day NaPB (in the form of Pheburane) or placebo per day. Although depending on body surface area, \~21 g Pheburane needs to be administered spread over the day 3 times taken with a meal.

Conditions

Interventions

DRUG

4.8 g/m^2/day NaPB

12-week oral administration of 4.8 g/m\^2/day NaPB (in the form of Pheburane) per day. Although depending on body surface area, \~21 g Pheburane needs to be administered spread over the day in 3 times taken with a meal.

DRUG

4.8 g/m^2/day placebo

12-week oral administration of 4.8 g/m\^2/day NaPB (in the form of Pheburane) or placebo per day. Although depending on body surface area, \~21 g Pheburane needs to be administered spread over the day in 3 times taken with a meal.

Sponsors & Collaborators

  • Maastricht University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
76 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2025-10-31
Completion
2026-05-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05836350 on ClinicalTrials.gov