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Clinical Trial Details

Trial ID: L5431
Source ID: NCT04921306
Associated Drug: Clenbuterol Hydrochloride
Title: Obese Human Beta-2-adrenergic Stimulation and Muscle Glucose Uptake
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Clenbuterol Hydrochloride|DRUG: Placebo
Outcome Measures: Primary: insulin-stimulated fluorodeoxyglucose (18F-FDG) uptake in quadriceps muscle., Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on insulin-stimulated 18F-FDG uptake in quadriceps muscle as assessed using radio-active labelled tracer (18F-FDG) in positron emission tomogaphy magnetic resonance imaging (PET-MRI)., 4 weeks | Secondary: insulin-stimulated 18F-FDG uptake in BAT, Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on insulin-stimulated 18F-FDG uptake in BAT as assessed using radio-active labelled tracer (18F-FDG) in PET-MRI., 4 weeks | Other: Body weight, Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on body weight, 4 weeks|Lean mass, Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on lean mass as assessed by Bodpod measurement, 4 weeks|Fat mass, Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on fat mass as assessed by Bodpod measurement, 4 weeks|Glucose infusion rate (GIR), Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on glucose-infusion rate (GIR) during a one-step hyperinsulinemic-euglycemic clamp, 4 weeks|Plasma insulin concentrations, Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on plasma insulin concentrations, 4 weeks|Plasma glucose concentrations, Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on plasma glucose concentrations, 4 weeks|Plasma free fatty acid (FFA) concentrations, Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on plasma FFA concentrations, 4 weeks|Plasma triacylglycerol (TAG) concentrations, Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on plasma (TAG) concentrations, 4 weeks|Heart rate, Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on heart rate as assessed by means of an automated cuff, 4 weeks|Blood pressure, Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on blood pressure (systolic and diastolic blood pressure) as assessed by means of an automated cuff, 4 weeks|Energy expenditure, Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on energy expenditure as measured by indirect calorimetry, 4 weeks|Substrate oxidation, Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on substrate oxidation as measured by indirect calorimetry, 4 weeks|Sleeping energy expenditure, Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on sleeping energy expenditure as assessed by means of whole-room indirect calorimetry, 4 weeks|Substrate oxidation during sleep, Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on substrate oxidation during sleep as assessed by means of whole-room indirect calorimetry, 4 weeks|Skeletal muscle gene expression, Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle gene expression of insulin signalling and beta-adrenergic pathways as determined in muscle biopsies by means of RT-qPCR, 4 weeks|Skeletal muscle protein expression, Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle protein expression of insulin signalling and adrenergic signalling pathways as determined in muscle biopsies by means of Western blot, 4 weeks|Femoral artery flow mediated dilation, Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on FMD as assessed by means of echo-doppler, 4 weeks|skeletal muscle GLUT4 translocation, Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle GLUT4 translocation as assessed by means of wide-field microscopy in skeletal muscle biopsies, 4 weeks
Sponsor/Collaborators: Sponsor: Maastricht University | Collaborators: Eurostars
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 14
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-08-16
Completion Date: 2024-03-01
Results First Posted:
Last Update Posted: 2024-05-07
Locations: Maastricht University, Maastricht, Netherlands
URL: https://clinicaltrials.gov/show/NCT04921306