Glucose tolerance
Conditions
Interventions
Trade Name: Carnitene
Product Name: Carnitene
Pharmaceutical Form: Chewable tablet
Sponsors
Maastricht University
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: • Haemoglobin levels 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives are to investigate whether L-carnitine supplementatiion improves insulin insulin sensitivity and metabolic flexibility in type 2 diabetic patients with a low carnitine status. ;Timepoint(s) of evaluation of this end point: After finilizing the study, meaning 36 included subjects ;Secondary Objective: To examine the effects of carnitine supplementation on intrahepatic lipid, body composition, sleep quality, quality of life, physical performance, cognition, acetylcarnitine formation, CrAT activity, acylcarnitine profiles and lipid profiles in type 2 diabetic patients with a low carnitine status;Primary end point(s): 2-step hyperinsulinemic euglycemic clamp combined with tracer kinetics and indirect calorimetry: - Whole body insulin sensitivity measured as GIR in µmol/kg/min during the stable period of the insulin phase of the clamp. - Hepatic insulin sensitivity measured as EGP in µmol/kg/min. - Peripheral insulin sensitivity measured as Rd in µmol/kg/min. - Metabolic flexibility (delta RER between basal and insulin stimulated state). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Maximal acetylcarnitine concentrations after exercise (measured using the 1H-MRS cycling measurement) - Intrahepatic lipid content (measured using 1H-MRS) - Body composition (Bodpod) - Metabolites in the blood before (i.e. glucose, free fatty acids, triglycerides, cholesterol, insulin) - CrAT activity (measured in muscle biopsies) - Acylcarnitine profiles (measured in muscle biopsies) - Lipid and lipid intermediates (measured in muscle biopsies) - Functional markers of physical performance - Quality of life - Quality of sleep ;Timepoint(s) of evaluation of this end point: After finilizing the study, meaning 36 included subjects | — |
Countries
Netherlands
Contacts
Public ContactNutrim
Maastricht University
Outcome results
None listed