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

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Placebo; Drug: Clenbuterol Hydrochloride

• Registration Number: NCT04921306
• Lead Sponsor: Maastricht University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-10
• Study Start: 2022-08-16
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

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

Exclusion Criteria

1. Not meeting all inclusion criteria

2. Cardiovascular disease (determined by means of questionnaires, heart rate/blood pressure measurements and an ECG)

3. Respiratory diseases (including asthma, bronchitis and COPD);

4. Unstable body weight (weight gain or loss > 3 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. Hyperthyroidism

9. Anaemia;

10. Epilepsy;

11. Smoking;

12. Renal and/or liver insufficiency;

13. Diagnosed with type 1 or type 2 diabetes mellitus;

14. Any contra-indications to MRI scanning. These contra-indications include patients with:

    1. Electronic implants such as pacemakers, defibrillators or neurostimulators
    2. Central nervous system aneurysm clip
    3. Some hearing aids (such as cochlear implant) and artificial (heart) valves which are contraindicated for MRI/MRS
    4. Iron containing corpora aliena in the eye or brains
    5. Claustrophobia

15. Participation in another biomedical study within 1 month before the first study visit, possibly interfering with the study results;

16. Medication use known to hamper subject's safety during the study procedures;

17. Subjects who do not want to be informed about unexpected medical findings;

18. Subjects who do not want that their treating physician to be informed;

19. Inability to participate and/or complete the required measurements;

20. Participation in organised or structured physical exercise (>2h per week);

21. 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects will ingest placebo capsules matching the clenbuterol hydrochloride capsules one time per day for a maximum of 28 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.
Clenbuterol hydrochloride	Clenbuterol Hydrochloride	Subjects will ingest clenbuterol hydrochloride capsules (20 microgram/each) twice daily (40 microgram/day) for a maximum of 28 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.

Primary Outcome Measures

Name	Time	Method
insulin-stimulated fluorodeoxyglucose (18F-FDG) uptake in quadriceps muscle.	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 Outcome Measures

Name	Time	Method
insulin-stimulated 18F-FDG uptake in BAT	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.

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Netherlands