Carnitine Supplementation in Type 2 Diabetic Patients

• Status: Completed
• Trial end date: 2019-11-11
• Target enrollment: 0
• Participant gender: All

Summary

the results from animal studies and preliminary human studies show that carnitine availability and acetylcarnitine concentrations are low in insulin resistant states such as with type 2 diabetes mellitus. However, in humans, carnitine supplementation is sometimes beneficial, but not in everyone. We hypothesize that this variability in response might be due to differences between individuals in the amount of carnitine in the muscle i.e. subjects with a low initial carnitine status will benefit more from supplementation. The state of the art non-invasive magnetic resonance spectroscopy method allows us to identify patients muscle acetylcarnitine status. Here we aim to test whether carnitine improves insulin sensitivity, furthermore, whether acetylcarnitine concentration at baseline or other characteristics are associated with the response (in insulin sensitivity) to carnitine supplementation. Furthermore, we will examine the potentially positive effect of carnitine supplementation in type 2 diabetes patients on intrahepatic lipid content, acetylcarnitine formation, blood plasma metabolites, body composition, physical performance and quality of life

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht University Medical Center
• Treatments: Insulin

Criteria

Inclusion Criteria:

• Men and woman

• Age: 40-75 years

• Woman should be postmenopausal

• BMI: 25-38 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)

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