Targeting the Beta-2-adrenergic Pathway to Improve Skeletal Muscle Glucose Uptake in Obese Humans
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- insulin-stimulated fluorodeoxyglucose (18F-FDG) uptake in quadriceps muscle.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or (postmenopausal; defined as 1 year after the last cycle) female;
- •Age between 40-70 years;
- •BMI: 27-35 kg/m2;
排除标准
- •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
- •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;
研究组 & 干预措施
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.
干预措施: Clenbuterol Hydrochloride (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
insulin-stimulated fluorodeoxyglucose (18F-FDG) uptake in quadriceps muscle.
时间窗: 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).
次要结局
- insulin-stimulated 18F-FDG uptake in BAT(4 weeks)