Clinical trial NCT04921306: Obese Human Beta-2-adrenergic Stimulation and Muscle Glucose Uptake
Official title: Targeting the Beta-2-adrenergic Pathway to Improve Skeletal Muscle Glucose Uptake in Obese Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: Eurostars
First posted: 2021-06-10
Enrollment: 14
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: insulin-stimulated fluorodeoxyglucose (18F-FDG) uptake in quadriceps muscle.
timeFrame: 4 weeks
Secondary outcomes:
measure: insulin-stimulated 18F-FDG uptake in BAT
timeFrame: 4 weeks
Other outcomes:
measure: Body weight
timeFrame: 4 weeks
measure: Lean mass
timeFrame: 4 weeks
measure: Fat mass
timeFrame: 4 weeks
measure: Glucose infusion rate (GIR)
timeFrame: 4 weeks
measure: Plasma insulin concentrations
timeFrame: 4 weeks
measure: Plasma glucose concentrations
timeFrame: 4 weeks
measure: Plasma free fatty acid (FFA) concentrations
timeFrame: 4 weeks
measure: Plasma triacylglycerol (TAG) concentrations
timeFrame: 4 weeks
measure: Heart rate
timeFrame: 4 weeks
measure: Blood pressure
timeFrame: 4 weeks
measure: Energy expenditure
timeFrame: 4 weeks
measure: Substrate oxidation
timeFrame: 4 weeks
measure: Sleeping energy expenditure
timeFrame: 4 weeks
measure: Substrate oxidation during sleep
timeFrame: 4 weeks
measure: Skeletal muscle gene expression
timeFrame: 4 weeks
measure: Skeletal muscle protein expression
timeFrame: 4 weeks
measure: Femoral artery flow mediated dilation
timeFrame: 4 weeks
measure: skeletal muscle GLUT4 translocation
timeFrame: 4 weeks
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
References: