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Completed

NCT Number: NCT04921306

Obese Human Beta-2-adrenergic Stimulation and Muscle Glucose Uptake

The purpose of this study is to investigate the effect of four weeks clenbuterol/placebo supplementation on skeletal muscle glucose disposal in overweight/obese male and (postmenopausal) female volunteers.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Maastricht University

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Caucasian;
  • Male or (postmenopausal; defined as 1 year after the last cycle) female;
  • Age between 40-70 years;
  • BMI: 27-35 kg/m2;

Exclusion criteria

  • Not meeting all inclusion criteria
  • Cardiovascular disease (determined by means of questionnaires, heart rate/blood pressure measurements and an ECG)
  • Respiratory diseases (including asthma, bronchitis and COPD);
  • Unstable body weight (weight gain or loss > 3 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;
  • Hyperthyroidism
  • Anaemia;
  • Epilepsy;
  • Smoking;
  • Renal and/or liver insufficiency;
  • Diagnosed with type 1 or type 2 diabetes mellitus;
  • Any contra-indications to MRI scanning. These contra-indications include patients with:
  • Electronic implants such as pacemakers, defibrillators or neurostimulators
  • Central nervous system aneurysm clip
  • Some hearing aids (such as cochlear implant) and artificial (heart) valves which are contraindicated for MRI/MRS
  • Iron containing corpora aliena in the eye or brains
  • Claustrophobia
  • 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 (>2h per week);
  • 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;

Treatment and study plan

Clenbuterol Hydrochloride

Drug

Daily ingestion of clenbuterol hydrochloride capsules (40 microgram/day) for a total period of 28 days with a wash-out period of at least 6-8 weeks.

Placebo

Drug

Daily ingestion of placebo capsules for a total period of 28 days with a wash-out period of at least 6-8 weeks.

Primary outcomes

  1. insulin-stimulated fluorodeoxyglucose (18F-FDG) uptake in quadriceps muscle.

    Time frame: 4 weeks

    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).

Secondary outcomes

  1. insulin-stimulated 18F-FDG uptake in BAT

    Time frame: 4 weeks

    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.

Other outcomes

  1. Body weight

    Time frame: 4 weeks

    Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on body weight

  2. Lean mass

    Time frame: 4 weeks

    Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on lean mass as assessed by Bodpod measurement

  3. Fat mass

    Time frame: 4 weeks

    Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on fat mass as assessed by Bodpod measurement

  4. Glucose infusion rate (GIR)

    Time frame: 4 weeks

    Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on glucose-infusion rate (GIR) during a one-step hyperinsulinemic-euglycemic clamp

  5. Plasma insulin concentrations

    Time frame: 4 weeks

    Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on plasma insulin concentrations

  6. Plasma glucose concentrations

    Time frame: 4 weeks

    Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on plasma glucose concentrations

  7. Plasma free fatty acid (FFA) concentrations

    Time frame: 4 weeks

    Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on plasma FFA concentrations

  8. Plasma triacylglycerol (TAG) concentrations

    Time frame: 4 weeks

    Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on plasma (TAG) concentrations

  9. Heart rate

    Time frame: 4 weeks

    Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on heart rate as assessed by means of an automated cuff

  10. Blood pressure

    Time frame: 4 weeks

    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

  11. Energy expenditure

    Time frame: 4 weeks

    Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on energy expenditure as measured by indirect calorimetry

  12. Substrate oxidation

    Time frame: 4 weeks

    Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on substrate oxidation as measured by indirect calorimetry

  13. Sleeping energy expenditure

    Time frame: 4 weeks

    Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on sleeping energy expenditure as assessed by means of whole-room indirect calorimetry

  14. Substrate oxidation during sleep

    Time frame: 4 weeks

    Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on substrate oxidation during sleep as assessed by means of whole-room indirect calorimetry

  15. Skeletal muscle gene expression

    Time frame: 4 weeks

    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

  16. Skeletal muscle protein expression

    Time frame: 4 weeks

    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

  17. Femoral artery flow mediated dilation

    Time frame: 4 weeks

    Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on FMD as assessed by means of echo-doppler

  18. skeletal muscle GLUT4 translocation

    Time frame: 4 weeks

    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

Sponsors and collaborators

Lead sponsor

Maastricht University

Other

Collaborators

  • Eurostars

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 10, 2021
Registry last updated
May 7, 2024

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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