Table of contents

• Trial overview
• Study design and phase
• Who can participate
• What is being measured
• What the trial is testing
• Important terms explained

Trial overview

The available clinical trial for Sodium Phenylbutyrate is titled “Role of BCAA in glucose homeostasis” and is listed as authorised.^[1] It is studying people with type 2 diabetes and is designed as an interventional trial, meaning researchers are giving a study treatment and then measuring the effect.^[1]

The intervention is listed as PHEBURANE 483 mg/g granules, given orally at 13 mg/m2.^[1] The source data identify this study as investigating Sodium Phenylbutyrate, so that is the substance name used in this article.^[1]

Study design and phase

This study is in Phase 3, which is an advanced stage of clinical testing.^[1] Phase 3 studies usually look more closely at how well a treatment works in a larger group than earlier-phase studies, although this specific trial still has a small planned enrollment.^[1]

The planned enrollment is 26 participants.^[1] Because the study is interventional, the researchers are not only observing patients but also testing whether the treatment changes the study outcome.^[1]

Who can participate

The trial is aimed at patients with type 2 diabetes.^[1] The provided trial data do not list extra inclusion or exclusion rules, so the clearest known target group is adults with this condition.^[1]

Because the study focuses on glucose control, it is meant for people in whom researchers want to see whether the intervention can improve blood sugar levels.^[1]

What is being measured

The primary outcome is glucose levels after an overnight fast, expressed in mmol/l.^[1] This means the study checks blood sugar after the person has not eaten overnight, which helps show the body’s baseline glucose control.^[1]

The brief summary says the main goal is to find out whether prolonged boosting of BCAA oxidation can substantially lower fasting plasma glucose in people with type 2 diabetes.^[1] In simple terms, the trial is asking whether the treatment can help lower blood sugar when measured in a fasting state.^[1]

What the trial is testing

The study title points to the role of BCAA in glucose homeostasis, which means blood sugar balance.^[1] The research question is not only about the treatment itself, but also about whether changing BCAA oxidation may affect fasting glucose in type 2 diabetes.^[1]

This makes the trial important for understanding a possible link between the study intervention and glucose control in a diabetes population.^[1] The available source does not report final results, so the focus is on the research goal rather than proven benefit.^[1]

Important terms explained

Interventional study means the researchers actively give a treatment and then measure what changes.^[1] Phase 3 means the study is in a later testing stage, usually used to better understand how a treatment performs in people.^[1]

Fasting plasma glucose is the amount of sugar in the blood after not eating overnight.^[1] mmol/l is the unit used to report this blood sugar result.^[1]

BCAA stands for branched-chain amino acids, and the trial is studying whether increasing their oxidation may improve glucose homeostasis.^[1] Glucose homeostasis means the body’s balance of blood sugar levels.^[1]