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Clinical Trial Details

Trial ID: L4694
Source ID: NCT02722902
Associated Drug: Carnitor
Title: Carnitine Infusion and Insulin Resistance
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Glucose Intolerance
Interventions: DRUG: Carnitor|DIETARY_SUPPLEMENT: IntraLipid|DIETARY_SUPPLEMENT: Placebo
Outcome Measures: Primary: 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, 6 hours|Metabolic flexibility, Change in RER comparing basal and insulin stimulated state during the clamp, 6-hours | Secondary: Maximal acetylcarnitine concentrations after exercise, Measured using 1H-MRS after 30 minutes of cycling at 70% Wmax, 45 minutes|glucose concentration in the blood before and during insulin stimulation, glucose concentration in the plasma will be measured via a blood draw, 6 hours|Carnitine acyltransferase (CRaT) enzyme activity (physiological parameter), CRaT activity will be measured in obtained muscle biopsies from the vastus Lateralis muscle using enzyme Activity Assays. Measurements will be obtained using 10 ml of sample incubated in 190 ml reaction buffer (50mM Tris-HCl, 1M EDTA, 0.45mM acetyl-CoA, 0.1mM DTNB; pH = 7.8). CrAT specific activity will be determined by measuring the rate of reduction of DTNB (412 nm) by the free CoA liberated from acetylCoA after adding 5mM L-carnitine and monitoring for 10 min, 6 hours|Acylcarnitine profile in the muscle (physiological parameter), In muscle tissue obtained via biopsies. Acylcarnitine measurements will be performed using flow injection tandem mass spectrometry, 6 hours|Lipid levels (physiological parameter), In muscle tissue obtained via biopsies, 6 hours|free fatty acid in the blood before and during insulin stimulation, free fatty acid concentration in the plasma will be measured via a blood draw, 6 hours|Triglycerides in the blood before and during insulin stimulation, Triglycerides wil be measured in the plasma via a blood draw, 6 hours|Insulin in the blood before and during insulin stimulation, Insulin wil be measured in the plasma via a blood draw, 6 hours
Sponsor/Collaborators: Sponsor: Maastricht University Medical Center
Gender: MALE
Age: ADULT
Phases:
Enrollment: 17
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2016-05
Completion Date: 2017-06
Results First Posted:
Last Update Posted: 2018-04-26
Locations: Maastricht University Medical Center, Maastricht, Limburg, 6229 ER, Netherlands
URL: https://clinicaltrials.gov/show/NCT02722902