Role of BCAA in glucose homeostasis
Key facts
- Where
- Maastricht, HollandiaSee the site
- Phase
- 4. fázis
Where in Hollandia
- Maastricht UniversityMaastricht, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Maastricht University
- Trial code
- EU 2023-503424-12-00
- Record updated
- 2026. május 12.
- Original description
The primary objective is to investigate if prolonged boosting of BCAA oxidation will substantially lower fasting plasma glucose levels in patients with T2D.Read full original descriptionShow less
Targeting branched-chain amino acid oxidation to improve glycaemic control in patients with type 2 diabetes
The primary objective is to investigate if prolonged boosting of BCAA oxidation will substantially lower fasting plasma glucose levels in patients with T2D.
Inclusion: 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.
Exclusion: 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; 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; 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; 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.