drugset / Trial / NCT05836350

Role of BCAA in Glucose Homeostasis

NCT05836350

Phase 4 Unknown 20 enrolled Maastricht University
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2023-06
Primary completion
2025-10
Completion
2026-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Phenylbutyrate Small molecule 4800 mg/m2 Oral