2024-517015-73-00招募中4 期
Muscle strength and -mass after bariatric surgery - a possible effect of testosterone replacement therapy? Randomized, placebo-controlled and double-blinded study
Esbjerg Og Grindsted Sygehus1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年9月20日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Maximal isometric muscle strength (N) in shoulder muscles (shoulder elevation.
研究概览
简要总结
To investigate the effect and clinical relevance of testosterone therapy combined with exercise and diet counselling in hypogonadal men undergoing bariatric surgery.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Eligible for bariatric surgery according to the Danish national criteria (i.e. aged 18‒60 years, BMI >35 kg/m2 with specific secondary disease or BMI >40 kg/m2 with significant health issues assessed by the multidisciplinary bariatric team) - Caucasian men - Total testosterone < 12.0 nmol/l - No contraindications for testosterone treatment
排除标准
- •Previously diagnosed with prostate, mammae or liver cancer. Any other cancer within the last 5 years. - Hypersensitivity to the active substance or to any of the excipients in Nebido® - Symptomatic heart disease NYHA >2 - Recently thromboembolic disease <3 months - PSA >4.0 ug/l or PSA>3.0 ug/l and lower urinary tract symptoms - Disability that severely affect the ability to perform exercise training - EVF > 52% - The following treatments are not allowed in the study:5-α-reductase inhibitors and Prednisolone >5mg/day
结局指标
主要结局
Maximal isometric muscle strength (N) in shoulder muscles (shoulder elevation.
Maximal isometric muscle strength (N) in shoulder muscles (shoulder elevation.
次要结局
- Regional body composition (DXA scan, BMI, Waist/hip-ratio) - Physical strength: maximal isometric muscle strength in lower extremities (hip extension, hip abduction), muscle strength in upper-extremities (shoulder abduction, shoulder adduction) - Physical function: performance-based measures of physical function (stair climb test) and maximal oxygen uptake (VO2max). - Glucose metabolism (HOMA-R, HbA1c, Fasting-P-Blood glucose) - Coagulation/fibrinolysis status (thrombin generation measures) - Ad
研究者
Line Velling Magnussen
Scientific
Esbjerg Og Grindsted Sygehus
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Testosterone in Bariatric PatientsBariatric Surgery CandidateMale HypogonadismMuscle LossNCT03721497Esbjerg Hospital - University Hospital of Southern Denmark64
已完成
不适用
Do patients having major abdominal surgery exhibit significant muscle wasting?Muscle wasting disease (myopenia)Musculoskeletal DiseasesMyopeniaISRCTN96363642Royal Surrey County Hospital Foundation Trust52
招募中
不适用
THE MUSCLE POWER STUDY: Surgery related muscle loss and muscle strength after complex abdominal surgery for pseudomyxoma peritonei, pancreatic, liver and colorectal cancer• pseudomyxoma peritonei (PMP)• liver tumor (primary cancer or colorectal liver metastases)• pancreatic cancer• bile duct cancer • colorectal cancerNL-OMON28560This work is supported by a grant from the UMCG Cancer Research Foundation (Institutional Foundation for Cancer Research and Development). The study protocol has not undergone any peer-review by this funding body, nor will they play a role in the analysis and interpretation of the data.178
招募中
不适用
Nutritional Stimulation of Muscle Protein Synthesis and Metabolic Rate After Bariatric SurgeryWeight LossNCT04751916Oregon Health and Science University40
尚未招募
不适用
Changes in muscle mass measured by ultrasound in children undergoing cardiac surgery and the effect of sarcopenia on prognosisKCT0003634Asan Medical Center100