Clinical trial NCT03800290: Human Beta-2 Adrenergic Stimulation and Muscle Glucose Uptake
Official title: Targeting the Beta-2-adrenergic Pathway to Improve Skeletal Muscle Glucose Uptake in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: Beta-2 adrenergic agonist
Glucose homeostasis
Skeletal muscle
Human
Lead sponsor: Maastricht University
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blinded, placebo-controlled, cross-over, single-center study
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Caucasian;
2. Male sex;
3. Age: 18-30
4. BMI: 18-25 kg/m2;
5. Normal physical activity levels;

Exclusion Criteria:

1. Not meeting all inclusion criteria
2. Cardiovascular diseases (determined by means of questionnaires, heart rate/blood pressure measurements)
3. Respiratory diseases (including asthma, bronchitis and COPD);
4. Unstable body weight (weight gain or loss \> 5 kg in the last three months);
5. Intention to lose or gain body weight (e.g. with caloric restriction or physical activity)
6. Excessive alcohol and/or drug abuse;
7. Hypokalaemia;
8. Hb \< 8.4 mmol/L;
9. Epilepsy;
10. Smoking;
11. Renal and/or liver insufficiency;
12. Participation in another biomedical study within 1 month before the first study visit, possibly interfering with the study results;
13. Medication use known to hamper subject's safety during the study procedures;
14. Subjects who do not want to be informed about unexpected medical findings;
15. Subjects who do not want that their treating physician to be informed;
16. Inability to participate and/or complete the required measurements;
17. Participation in organised or structured physical exercise;
18. 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;
19. Hyperthyroidism

Primary outcomes:
measure: Insulin-stimulated peripheral glucose disposal (Rd)
timeFrame: 2 weeks
Secondary outcomes:
measure: Skeletal muscle GLUT4 translocation
timeFrame: acute (4 hours) and long-term (2 weeks)
Other outcomes:
measure: Body weight/composition
timeFrame: 2 weeks
measure: Plasma substrates
timeFrame: Acute (4 hours) and long-term (1 and 2 weeks)
measure: Heart rate
timeFrame: Acute (4 hours) and long-term (1 and 2 weeks)
measure: Blood pressure
timeFrame: Acute (4 hours) and long-term (1 and 2 weeks)
measure: Insulin-mediated suppression of hepatic glucose production
timeFrame: 2 weeks
measure: Energy expenditure and substrate oxidation
timeFrame: Acute (4 hours) and long-term (2 weeks)
measure: Sleeping energy expenditure and substrate oxidation
timeFrame: 2-weeks
measure: Skeletal muscle glycogen
timeFrame: 2 weeks
measure: Skeletal muscle lipid content using wide-field microscopie
timeFrame: 2 weeks
measure: Skeletal muscle gene expression
timeFrame: Acute (4 hours) and long-term (1 and 2 weeks)
measure: Skeletal muscle protein expression using western blotting
timeFrame: Acute (4 hours) and long-term (1 and 2 weeks)
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
affiliation: principle investigator
name: Joris Hoeks, PhD
role: PRINCIPAL_INVESTIGATOR
References: