Carnitine supplementation as a therapy to improve insulin sensitivity in Type 2 diabetic patients with low carnitine status

Completed

• Conditions: non insulin dependant diabetes; type 2 diabetes mellitus; 10018424

• Registration Number: NL-OMON48695
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 62

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)

Exclusion Criteria

• Haemoglobin levels < 7.8 mmol/L
• Uncontrolled hypertension
• Use of anticoagulants
epilepsy
• Insulin dependent type 2 diabetic patients.
• 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
• Signs of clinical relevant diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study endpoints are insulin sensitivity and metabolic flexibility,<br /><br>measured by the hyperinsulinemic-euglycemic clamp. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are maximal acetylcarnitine concentrations after exercise,<br /><br>Intrahepatic lipid content, body composition, metabolites in the blood before<br /><br>(i.e. glucose, free fatty acids, triglycerides, cholesterol, insulin), CrAT<br /><br>activity, acylcarnitine profiles, lipid and lipid intermediates, functional<br /><br>markers of physical performance, quality of life and quality of sleep. </p><br>