The Effects of Lifestyle-modification Induced Weight Loss on Metabolic and Inflammatory Profile, Endothelial, Sexual and Urinary Function, and Quality of Life in Obese Men
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Changi General Hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- erectile function
Study Overview
Brief Summary
This study aims to evaluate the extent to which weight loss of 5-10% from baseline, induced by exercise and diet, improves metabolic and inflammatory profile, endothelial function, erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life in obese men.
Detailed Description
This study aims to evaluate the extent to which weight loss of 5-10% from baseline, induced by exercise and diet, improves 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 referrals to the Sports Medicine Centre in Changi General Hospital. The study will be conducted at the Sports Medicine Centre by trained medical investigators, dieticians and sports trainers.At baseline, 12 and 24 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male, aged 30-65 years
- •Body Mass Index (BMI) >/= 27.5 kg/m2
- •Waist circumference (WC) >/= 90 cm
Exclusion Criteria
- •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
Arms & Interventions
lifestyle counselling
exercise and diet counselling for weight loss
Intervention: Exercise and diet (Behavioral)
Outcomes
Primary Outcomes
erectile function
Time Frame: 24 weeks
Increase in IIEF-5 score
Secondary Outcomes
- lower urinary tract symptoms(24 weeks)