Role of BCAA in Glucose Homeostasis

NCT05836350 | Not Yet Recruiting Phase 4

• 1 other identifier: NaPB-2
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Type 2 Diabetes

Keywords

type 2 Diabetes; branched-chain amino acid metabolism; glucose homeostasis; sodium-phenylbutyrate; insulin resistance

Outcome Measures

Primary Outcomes (1)

• fasting plasma glucose levels

  Glucose levels will be measured after an overnight fast expressed in mmol/l.

  at week 12 of each intervention period

Secondary Outcomes (10)

• whole-body insulin sensitivity

  at week 6 and week 12 of each intervention period

• muscle mitochondrial function

  at week 6 and week 12 of each intervention period

• whole-body metabolic flexibility

  at week 12 of each intervention period

• energy status of the heart

  at week 12 of each arm

• cardiac function: ejection fraction

  at week 12 of each arm

Study Arms (2)

4.8 g/m^2/day NaPB

ACTIVE COMPARATOR

12-week oral administration of 4.8 g/m\^2/day Sodium-phenylbutyrate (NaPB) (in the form of Pheburane)

Drug: 4.8 g/m^2/day NaPB

4.8 g/m^2/day Placebo

PLACEBO COMPARATOR

12-week oral administration of 4.8 g/m2/day identical placebo granules.

Drug: 4.8 g/m^2/day placebo

Interventions

4.8 g/m^2/day NaPB DRUG

12-week oral administration of 4.8 g/m\^2/day NaPB (in the form of Pheburane) per day. Although depending on body surface area, \~21 g Pheburane needs to be administered spread over the day in 3 times taken with a meal.

Also known as: Pheburane, NaPB

4.8 g/m^2/day NaPB

4.8 g/m^2/day placebo DRUG

12-week oral administration of 4.8 g/m\^2/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 in 3 times taken with a meal.

Also known as: Placebo

4.8 g/m^2/day Placebo

Eligibility Criteria

• Age: 40 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Central Study Contacts

Esther Phielix, PhD.

CONTACT

043- 388 1311; esther.phielix@maastrichtuniversity.nl

Elnaz Daraei, MSc.

CONTACT

elnaz.daraei@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: May 1, 2023
• Study Start: June 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share