Human Beta-2 Adrenergic Stimulation and Muscle Glucose Uptake

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of two weeks clenbuterol/placebo supplementation on skeletal muscle glucose disposal in healthy male volunteers.

Official Title
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Targeting the Beta-2-adrenergic Pathway to Improve Skeletal Muscle Glucose Uptake in Healthy Humans

Conditions
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Healthy

Intervention / Treatment
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* Drug: Clenbuterol Hydrochloride
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caucasian; Male sex; Age: 18-30 BMI: 18-25 kg/m2; Normal physical activity levels; Exclusion Criteria: Not meeting all inclusion criteria Cardiovascular diseases (determined by means of questionnaires, heart rate/blood pressure measurements) Respiratory diseases (including asthma, bronchitis and COPD); Unstable body weight (weight gain or loss > 5 kg in the last three months); Intention to lose or gain body weight (e.g. with caloric restriction or physical activity) Excessive alcohol and/or drug abuse; Hypokalaemia; Hb < 8.4 mmol/L; Epilepsy; Smoking; Renal and/or liver insufficiency; Participation in another biomedical study within 1 month before the first study visit, possibly interfering with the study results; Medication use known to hamper subject's safety during the study procedures; Subjects who do not want to be informed about unexpected medical findings; Subjects who do not want that their treating physician to be informed; Inability to participate and/or complete the required measurements; Participation in organised or structured physical exercise; Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk; Hyperthyroidism

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, double-blinded, placebo-controlled, cross-over, single-center study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clenbuterol hydrochloride<br>Subjects will ingest clenbuterol hydrochloride capsules (20 microgram/each) twice daily (40 microgram/day) for a maximum of 14 days. Subjects that received the clenbuterol hydrochloride capsules (at random) in the first study period will receive the placebo capsules during the second study period. | Drug: Clenbuterol Hydrochloride<br>* Daily ingestion of clenbuterol hydrochloride capsules (40 microgram/day) for a total period of 14 days with a wash-out period of 4 weeks.<br>|
| Placebo Comparator: Placebos<br>Subjects will ingest placebo capsules matching the clenbuterol hydrochloride capsules one time per day for a maximum of 14 days. Subjects that received the placebo capsules (at random) in the first study period will receive the clenbuterol hydrochloride capsules during the second study period. | Drug: Placebos<br>* Daily ingestion of placebo capsules for a total period of 14 days with a wash-out period of 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin-stimulated peripheral glucose disposal (Rd) | Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on insulin-stimulated peripheral glucose disposal (Rd) during the high-insulin infusion step during the two-step hyperinsulinemic-euglycemic clamp. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal muscle GLUT4 translocation | Comparison between acute (4h) and prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle GLUT4 translocation as assessed by means of wide-field microscopy in skeletal muscle biopsies | acute (4 hours) and long-term (2 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Beta-2 adrenergic agonist, Glucose homeostasis, Skeletal muscle, Human