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Completed

NCT Number: NCT03800290

Human Beta-2 Adrenergic Stimulation and Muscle Glucose Uptake

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.

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Key information

Conditions

Healthy

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clenbuterol Hydrochloride

Drug

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

Drug

Daily ingestion of placebo capsules for a total period of 14 days with a wash-out period of 4 weeks.

Primary outcomes

  1. Insulin-stimulated peripheral glucose disposal (Rd)

    Time frame: 2 weeks

    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.

Secondary outcomes

  1. Skeletal muscle GLUT4 translocation

    Time frame: acute (4 hours) and long-term (2 weeks)

    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

Other outcomes

  1. Body weight/composition

    Time frame: 2 weeks

    Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on body weight and composition as assessed by means of a Bodpod measurement.

  2. Plasma substrates

    Time frame: Acute (4 hours) and long-term (1 and 2 weeks)

    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.

  3. Heart rate

    Time frame: Acute (4 hours) and long-term (1 and 2 weeks)

    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.

  4. Blood pressure

    Time frame: Acute (4 hours) and long-term (1 and 2 weeks)

    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.

  5. Insulin-mediated suppression of hepatic glucose production

    Time frame: 2 weeks

    Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on hepatic glucose production as assessed during the two-step hyperinsulinemic-euglycemic clamp.

  6. Energy expenditure and substrate oxidation

    Time frame: Acute (4 hours) and long-term (2 weeks)

    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.

  7. Sleeping energy expenditure and substrate oxidation

    Time frame: 2-weeks

    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).

  8. Skeletal muscle glycogen

    Time frame: 2 weeks

    Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle glycogen as assessed in muscle biopsies.

  9. Skeletal muscle lipid content using wide-field microscopie

    Time frame: 2 weeks

    Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle lipid content as assessed in muscle biopsies by wide-field microscopie.

  10. Skeletal muscle gene expression

    Time frame: Acute (4 hours) and long-term (1 and 2 weeks)

    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

  11. Skeletal muscle protein expression using western blotting

    Time frame: Acute (4 hours) and long-term (1 and 2 weeks)

    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

Sponsors and collaborators

Lead sponsor

Maastricht University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2019
Registry last updated
Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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