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NOT YET RECRUITING
NCT05836350
PHASE4

Role of BCAA in Glucose Homeostasis

Sponsor: Maastricht University

View on ClinicalTrials.gov

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.

Official title: Targeting Branched-chain Amino Acid Oxidation to Improve Glycaemic Control in Patients With Type 2 Diabetes

Key Details

Gender

All

Age Range

40 Years - 76 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-06

Completion Date

2026-05

Last Updated

2023-05-01

Healthy Volunteers

No

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.