Glucose tolerance
Conditions
Interventions
Trade Name: Carnitor
Product Name: Carnitor
Pharmaceutical Form: Infusion
Sponsors
Maastricht University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Caucasian • Healthy (as determined by responsible physician based on a medical questionnaire) • Male • Age: 18-40 years • Normal BMI: 18-25 kg/m2 • Stable dietary habits • No use of medication interfering with investigated study parameters (as determined by responsible physician) 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 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Female • Haemoglobin levels 3 hours a week • Being vegetarian or vegan (because of altered whole body carnitine status) • Smoking • 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 • Medication use known to interfere with investigated study parameters • 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 • Subjects who do not want that their treating physician is informed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives are to investigate whether L-carnitine infusion may rescue lipid-induced insulin resistance and whether L-carnitine infusion is improving metabolic flexibility in the state of lipid-induced insulin resistance. ;Secondary Objective: a secondary objective is to examine the molecular pathways of carnitine and acetylcarnitine, responsible for muscle insulin sensitivity. ;Primary end point(s): - Whole body insulin sensitivity measured as GIR in µmol/kg/min during the stable period of the insulin phase of the clamp. - Peripheral insulin sensitivity measured as Rd in µmol/kg/min. - Metabolic flexibility (delta RER between basal and insulin stimulated state). ;Timepoint(s) of evaluation of this end point: after 3 subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Maximal acetylcarnitine concentrations after exercise (measured using the 1H-MRS cycling measurement) -Metabolites in the blood before and during insulin stimulation (i.e. glucose, free fatty acids, triglycerides, cholesterol, insulin) - CrAT activity (measured in muscle biopsies) - Acylcarntine profiles (measured in muscle biopsies) - Lipid and lipid intermediates (measured in muscle biopsies) ;Timepoint(s) of evaluation of this end point: na 10 proefpersonen | — |
Countries
Netherlands
Contacts
Public Contactnutrim
Universiteit Maastricht
Outcome results
None listed