To boost aminoacid oxidation in diabetes

Phase 1

• Conditions: type 2 diabetes; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2018-003176-13-NL
• Lead Sponsor: Maastricht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-23
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following 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 = 70 years. Males are aged = 40 years and = 70 years
3.Patients should have suitable veins for cannulation or repeated venipuncture
4.Caucasians
5.BMI: 28-38 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
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.Smoking
8.Men: Hb <8.4 mmol/L, Women: Hb <7.8 mmol/l

A medical doctor will judge participation eligibility based on the medical history questionnaire, medication use and fasting blood parameters. If the medical doctor advises that a patient cannot participate, the patient will be excluded from enrollment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective is the delta change in whole body insulin sensitivity expressed as glucose disposal rate (µmol/kg/min) upon 2 weeks of Na-PB vs. placebo treatment. ;Secondary Objective: Secondary objectives are muscle mitochondrial oxidative capacity (pmol/mg/s), muscle and liver fat content (%), leucine oxidation rate (µmol/kg/min) and energy metabolism (respiratory exchange ratio and kJ/kg/min). ;Primary end point(s): The endpoint of study is the measurement of insulin sensitivity of the 16th participant after the second intervention period. ;Timepoint(s) of evaluation of this end point: after finalising the second intervention period

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The second endpoints of study are the measurements of mitochondrial function, energy metabolism, leucine oxidation, muscle and liver fat of the 16th participant ;Timepoint(s) of evaluation of this end point: after the second intervention period.