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Study on Sodium Phenylbutyrate for Improving Blood Sugar Control in Type 2 Diabetes Patients

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Type 2 diabetes, a condition where the body struggles to control blood sugar levels. The treatment being tested is called PHEBURANE, which contains the active ingredient sodium phenylbutyrate. This medication is taken orally in the form of granules. The purpose of the study is to see if this treatment can help lower blood sugar levels in people with Type 2 diabetes by improving how the body processes certain nutrients called branched-chain amino acids.

Participants in the study will take the medication over a period of time, and their blood sugar levels will be monitored to see if there are any changes. The study will also look at other aspects of health, such as how well the heart is working and how the body uses oxygen. These measurements will be taken using various methods, including MRI and other non-invasive tests. The study aims to provide a better understanding of how this treatment might help manage Type 2 diabetes.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The study is designed to last for several months, allowing researchers to gather enough information to determine the effectiveness of PHEBURANE in managing blood sugar levels in people with Type 2 diabetes. This research could lead to new ways to help people with this condition maintain better control over their blood sugar levels.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide signed and dated written informed consent. This confirms your understanding and agreement to participate in the clinical trial.
Step 2
Initial assessment
An initial assessment will be conducted to ensure you meet the eligibility criteria. This includes checking for no signs of active liver or kidney malfunction, confirming your age and post-menopausal status if applicable, and ensuring you have suitable veins for blood tests.
Your medical history will be reviewed to confirm a diagnosis of type 2 diabetes for at least 1.5 years, and that your condition is relatively well-controlled with an HbA1c level of less than 8.5%.
Step 3
Medication administration
You will be given PHEBURANE 483 mg/g granules to take orally. The dosage and frequency will be determined by the study team and will be explained to you in detail.
The medication is intended to boost the oxidation of branched-chain amino acids, which may help lower fasting plasma glucose levels.
Step 4
Regular monitoring
Throughout the study, your glucose levels will be measured after an overnight fast. This will help assess the impact of the medication on your blood sugar levels.
Additional tests will be conducted at specific intervals, such as a glucose tolerance test at 6 weeks and a glucose disposal rate test at 12 weeks.
Step 5
Additional assessments
Your cardiac function will be evaluated using imaging techniques like MRI and ultrasound to measure heart performance.
Cognitive function will be assessed through computerized tests and questionnaires to monitor any changes in mental health and sleep quality.
Step 6
Completion of the study
The study is expected to conclude by September 2026. Upon completion, you will receive a final assessment to evaluate the overall effects of the treatment.
Results from the study will contribute to understanding the role of branched-chain amino acids in managing type 2 diabetes.

Who can join the trial?

10 criteria

Patients must be able to provide signed and dated written informed consent before any study-specific procedures.
No signs of active liver or kidney problems.
Women must be post-menopausal, which means they have not had a menstrual period for at least 1 year, and be aged between 45 and 76 years. Men must be aged between 40 and 76 years.
Patients should have suitable veins for inserting a needle or for repeated blood draws.
Must be of Caucasian ethnicity.
Body Mass Index (BMI) should be between 25 and 38 kg/m². BMI is a measure of body fat based on height and weight.
Must have been diagnosed with Type 2 diabetes at least 1.5 years before the start of the study.
Diabetes should be relatively well-controlled, with an HbA1c level of less than 8.5%. HbA1c is a blood test that shows average blood sugar levels over the past 2 to 3 months.
Must be taking oral medication to lower blood sugar, specifically metformin alone or in combination with sulfonylurea agents, and/or a stable dose of a DPPIV inhibitor for at least the last 3 months.
No signs of active diabetes-related health issues like heart disease, diabetic foot problems, nerve damage (polyneuropathy), or eye problems (retinopathy).

Who cannot join the trial?

4 criteria

Patients who do not have Type 2 diabetes cannot participate. Type 2 diabetes is a condition where the body does not use insulin properly, leading to high blood sugar levels.
Individuals who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
People who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may have additional risks or require special protection in research.
Both males and females are eligible, so gender is not an exclusion criterion.

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Investigated drugs

Branched-Chain Amino Acids (BCAAs) are a group of essential nutrients that include three amino acids: leucine, isoleucine, and valine. In this clinical trial, the focus is on enhancing the breakdown of these amino acids in the body. The goal is to see if this process can help lower blood sugar levels in people with type 2 diabetes. By boosting the body's ability to use these amino acids, researchers hope to improve how the body manages blood sugar, which is crucial for people with diabetes.

Sodium Phenylbutyrate

What is already known about the treatment

Branched-Chain Amino Acid Oxidation Booster – This medication is administered orally and is currently being studied in clinical trials for its potential to help manage type 2 diabetes. It is not yet widely recognized in medical literature as a standard treatment. The main therapeutic goal is to improve blood sugar control in people with type 2 diabetes by enhancing the breakdown of certain amino acids in the body. At the molecular level, it works by increasing the oxidation of branched-chain amino acids, which may help lower blood sugar levels. This medication falls under the pharmacological category of metabolic regulators.

Investigated diseases

Type 2 Diabetes – Type 2 diabetes is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body's cells do not respond properly to insulin, and a relative lack of insulin production. Over time, high blood sugar levels can lead to various complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The disease often develops slowly, and individuals may not notice symptoms initially. Common symptoms include increased thirst, frequent urination, hunger, fatigue, and blurred vision. As the condition progresses, it may lead to more severe health issues if not managed properly.