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临床试验/NCT01554865
NCT01554865已完成4 期

The Effects of Diet-induced Weight Loss on Metabolic and Inflammatory Profile, Endothelial, Sexual and Urinary Function, and Quality of Life in Obese Men

Changi General Hospital2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
70
试验地点
2
主要终点
erectile function

研究概览

简要总结

This study aims to compare the efficacy of a partial meal replacement diet with a conventional diet, for inducing weight loss and improving metabolic and inflammatory profile, endothelial function, erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life in obese men.

详细描述

This study aims to compare the efficacy of a partial meal replacement diet with a conventional diet, for inducing weight loss, and improving metabolic and inflammatory profile, endothelial function, erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life in obese men. Men aged 30-65 years, with body mass index (BMI) ≥ 27.5 kg/m2, will be recruited from the community in Singapore. The study will be conducted at Changi General Hospital by trained medical investigators, dieticians and sports trainers. At baseline and 12 weeks, fasting glucose and lipids, insulin, testosterone, sex-hormone binding globulin, serum C-reactive protein and interleukin-6 are measured, endothelial function is measured by the non-invasive EndoPAT method, and validated questionnaires administered to assess changes in erectile function, sexual desire, LUTS and quality of life

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male, aged 30-65 years
  • Body Mass Index (BMI) >/= 27.5 kg/m2
  • Waist circumference (WC) >/= 90 cm

排除标准

  • pituitary disease or cranial radiotherapy
  • previous or current androgen replacement or deprivation therapy
  • current treatment for sexual problems or LUTS
  • glomerular filtration rate < 60 ml/min
  • liver disease
  • alcohol intake exceeding 500 g/week in the previous 12 months
  • use of opiates, glucocorticoids, recreational drugs or phosphodiesterase inhibitors

结局指标

主要结局

erectile function

时间窗: 12 weeks

increase in IIEF-5 score

次要结局

  • lower urinary tract symptoms(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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