Role of BCAA in Glucose Homeostasis

• Status: Not yet recruiting
• Trial end date: 2026-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial study aims to evaluate the effects of prolonged NaPB treatment in a maximum of 20 patients with T2D. The primary objective is:

to investigate if prolonged boosting of ing BCAA oxidation will substantially lower plasma glucose levels in patients with T2D.

Participants will undergo a Clinical randomized controlled trial (RCT) with a double-blinded, placebo-controlled, cross-over design, including a wash-out period of 12 weeks. The trial will contain 2 treatment arms, with each a duration of 12 weeks.

Participants will have a 12-week oral administration of 4.8 g/m2/day NaPB (in the form of Pheburane) or placebo per day. Although depending on body surface area, ~21 g Pheburane needs to be administered spread over the day 3 times taken with a meal.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht University

Criteria

Inclusion Criteria:

1. Patients are able to provide signed and dated written informed consent prior to any study specific procedures

2. 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

3. Patients should have suitable veins for cannulation or repeated venipuncture

4. Caucasians

5. BMI: 25-38 kg/m2

6. Diagnosed with T2D at least 1.5 years before the start of the study

7. Relatively well-controlled T2D: HbA1c < 8.5%

8. 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

9. No signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy

10. No signs of active liver or kidney malfunction

Exclusion Criteria:

1. Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator

2. Participate in physical activity more than 3 times a week

3. Unstable body weight (weight gain or loss > 5 kg in the last three months)

4. Insulin dependent T2D

5. Patients with congestive heart failure and and/or severe renal and or liver insufficiency or known sodium retention with oedema

6. Patients using Probalan (probenecid), Haldol (haloperidol), Depakene (valproate) or medical products containing corticosteroids

7. Men: Hb <8.4 mmol/L, Women: Hb <7.8 mmol/l

8. 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