Carnitine supplementation in type 2 diabetic patients

Phase 1

• Conditions: Glucose tolerance; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-003124-73-NL
• Lead Sponsor: Maastricht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-29
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

•Men and woman
•Age: 40-70 years
•Woman should be postmenopausal
•BMI: 25-35 kg/m2
•Stable dietary habits
•No use of medication interfering with investigated study parameters (as determined by responsible physician)
•Use of oral glucose lowering medication (metformin only or in combination with sulfonylurea agents)

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 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

•Haemoglobin levels < 7.8 mmol/L •Uncontrolled hypertension •Use of anticoagulants •Insulin dependent type 2 diabetic patients. •No signs of active liver or kidney malfunction. •Engagement in exercise > 3 hours a week •Being vegetarian or vegan (because of altered whole body carnitine status) •Alcohol and/or drug abuse •Unstable body weight (weight gain or loss > 5kg in the last 3 months) •Significant food allergies/intolerances (seriously hampering study meals) •Participation in another biomedical study within 1 month before the first study visit, which would possibly hamper our study results •Medication use known to hamper subject's safety during the study procedures •Subjects with contra-indications for MRI •Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the study •Subjects who do not want to be informed about unexpected medical findings •No signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy

Study & Design

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