Status:
COMPLETED
Carnitine Supplementation in Type 2 Diabetic Patients
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Glucose Intolerance
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief 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 melli...
Detailed Description
Rationale: Type 2 diabetic patients are characterized by a decreased metabolic flexibility: a reduced capability to switch from fat oxidation in the basal state to carbohydrate oxidation in the insuli...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2019
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03230812
Start Date
March 1 2018
End Date
November 11 2019
Last Update
December 7 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Maastricht University
Maastricht, Limburg, Netherlands, 6229ER