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

NCT04921306 | Completed Phase 2 DMC

• 1 other identifier: NL76746.068.21
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

  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).

  4 weeks

Secondary Outcomes (1)

• insulin-stimulated 18F-FDG uptake in BAT

  4 weeks

Other Outcomes (18)

• Body weight

  4 weeks

• Lean mass

  4 weeks

• Fat mass

  4 weeks

Study Arms (2)

Clenbuterol hydrochloride

EXPERIMENTAL

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.

Drug: Clenbuterol Hydrochloride

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

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.

Clenbuterol hydrochloride

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.

Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University: lead
• Eurostars: collaborator

Study Sites (1)

Maastricht University

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 10, 2021
• Study Start: August 16, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

NL (1)