Human Beta-2 Adrenergic Stimulation and Muscle Glucose Uptake

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03800290
• Other study ID #: NL67646.068.18
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2019
• Est. completion date: April 23, 2021

Study information

• Verified date: July 2020
• Source: Maastricht University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 23, 2021
• Est. primary completion date: April 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Clenbuterol Hydrochloride
Daily ingestion of clenbuterol hydrochloride capsules (40 microgram/day) for a total period of 14 days with a wash-out period of 4 weeks.
• Placebos
Daily ingestion of placebo capsules for a total period of 14 days with a wash-out period of 4 weeks.

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body weight/composition	Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on body weight and composition as assessed by means of a Bodpod measurement.	2 weeks
Other	Plasma substrates	Comparison between acute (4h) and prolonged (1 and 2 weeks) clenbuterol hydrochloride or placebo supplementation on plasma substrate concentrations, including insulin, glucose, free fatty acids and TAGs.	Acute (4 hours) and long-term (1 and 2 weeks)
Other	Heart rate	Comparison between acute (4h) and prolonged (1 and 2 weeks) clenbuterol hydrochloride or placebo supplementation on heart rate as measured by means of an automated cuff.	Acute (4 hours) and long-term (1 and 2 weeks)
Other	Blood pressure	Comparison between acute (4h) and prolonged (1 and 2 weeks) clenbuterol hydrochloride or placebo supplementation on blood pressure (systolic and diastolic) as measured by means of an automated cuff.	Acute (4 hours) and long-term (1 and 2 weeks)
Other	Insulin-mediated suppression of hepatic glucose production	Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on hepatic glucose production as assessed during the two-step hyperinsulinemic-euglycemic clamp.	2 weeks
Other	Energy expenditure and substrate oxidation	Comparison between acute (4h) and prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on energy expenditure and substrate oxidation as assessed by means of indirect calorimetry.	Acute (4 hours) and long-term (2 weeks)
Other	Sleeping energy expenditure and substrate oxidation	Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on sleeping energy expenditure and substrate oxidation as assessed by means of a metabolic chamber (indirect calorimetry).	2-weeks
Other	Skeletal muscle glycogen	Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle glycogen as assessed in muscle biopsies.	2 weeks
Other	Skeletal muscle lipid content using wide-field microscopie	Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle lipid content as assessed in muscle biopsies by wide-field microscopie.	2 weeks
Other	Skeletal muscle gene expression	Comparison between acute (4h) and prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle gene expression of specific pathways as determined in muscle biopsies by means of RT-qPCR	Acute (4 hours) and long-term (1 and 2 weeks)
Other	Skeletal muscle protein expression using western blotting	Comparison between acute (4h) and prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle protein expression of specific pathways as determined in muscle biopsies as determined by means of Western Blotting	Acute (4 hours) and long-term (1 and 2 weeks)
Primary	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	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)