Role of BCAA in Glucose Homeostasis (NaPB2)
Type 2 Diabetes
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring type 2 Diabetes, branched-chain amino acid metabolism, glucose homeostasis, sodium-phenylbutyrate, insulin resistance
Eligibility Criteria
Inclusion Criteria: Patients are able to provide signed and dated written informed consent prior to any study specific procedures 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 No signs of active liver or kidney malfunction Exclusion Criteria: Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator 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 Patients with congestive heart failure and and/or severe renal and or liver insufficiency or known sodium retention with oedema Patients using Probalan (probenecid), Haldol (haloperidol), Depakene (valproate) or medical products containing corticosteroids Men: Hb <8.4 mmol/L, Women: Hb <7.8 mmol/l 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
4.8 g/m^2/day NaPB
4.8 g/m^2/day Placebo
12-week oral administration of 4.8 g/m^2/day Sodium-phenylbutyrate (NaPB) (in the form of Pheburane)
12-week oral administration of 4.8 g/m2/day identical placebo granules.