2023-503424-12-00RecruitingPhase 4
Role of BCAA in glucose homeostasis
Targeting branched-chain amino acid oxidation to improve glycaemic control in patients with type 2 diabetes
Source: EU CTIS (euclinicaltrials.eu) · Last updated 12 May 2026
Brief summary (registry, in English)
The primary objective is to investigate if prolonged boosting of BCAA oxidation will substantially lower fasting plasma glucose levels in patients with T2D.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- First submitted
- 12 Apr 2023
- Start date
- 14 Apr 2025
- Lead sponsor
- Maastricht University
- Diseases
- Type 2 diabetes
- EU CT number
- 2023-503424-12-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 26
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 to 76 with type 2 diabetes that is fairly well controlled. Women must be past menopause.
- Age
- Men: 40 to 76 years. Women: 45 to 76 years and post-menopausal (at least 1 year since periods stopped).
- Sex
- Men and women (women must be post-menopausal).
- Disease stage
- Type 2 diabetes diagnosed at least 1.5 years ago, fairly well controlled (HbA1c below 8.5%). No signs of active diabetes-related problems such as active heart disease, active diabetic foot, nerve damage or eye damage. BMI 25-38 kg/m2.
- Earlier treatment
- Must take only metformin, alone or with sulfonylurea medicines and/or a stable dose of a DPPIV inhibitor for at least the last 3 months.
- Biomarker or test result
- HbA1c below 8.5%.
Main reasons for not taking part
- Type 2 diabetes treated with insulin
- Heart failure, or severe kidney or liver problems
- Weight change of more than 5 kg in the last 3 months
- Being in a study of an investigational product in the last 3 months
- Any reason that makes an MRI scan unsafe, such as a pacemaker or cochlear implant
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator
- Patients using Probalan (probenecid), Haldol (haloperidol), Depakene (valproate) or medical products containing corticosteroids
Other illness
- Any contra-indication MRI scanning. These contra-indications include patients with e.g. the following: • Central nervous system aneurysm clip • Implanted neural stimulator • Implanted cardiac pacemaker of defibrillator • Cochlear implant • Metal containing corpora aliena in the eye or brains
Lab values
- Patients with congestive heart failure and and/or severe renal and or liver insufficiency or known sodium retention with oedema
- Men: Hb <8.4 mmol/L, Women: Hb <7.8 mmol/l
Other
- Participate in physical activity more than 3 times a week
- Unstable body weight (weight gain or loss > 5 kg in the last three months)
- Insulin dependent T2D
Who the study is looking for
- Patients are able to provide signed and dated written informed consent prior to any study specific procedures
- No signs of active liver or kidney malfunction
- Women are post-menopausal (defined as at least 1 year post cessation of menses) and aged ≥ 45 and ≤ 76 years. Males are aged ≥ 40 years and ≤ 76 years
- Patients should have suitable veins for cannulation or repeated venipuncture
- Caucasians
- BMI: 25-38 kg/m2
- Diagnosed with T2D at least 1.5 years before the start of the study
- Relatively well-controlled T2D: HbA1c < 8.5%
- Oral glucose lowering medication: metformin only or in combination with sulfonylurea agents and/or on stable dose of a DPPIV inhibitor treatment for at least the last 3 months
- No signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht University | Maastricht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.