Effects of Lifestyle-modification Induced Weight Loss on Sexual and Urinary Function, and Quality of Life in Obese Men

Phase 4

Completed

• Conditions: Sexual Dysfunction; Endothelial Dysfunction; Quality of Life; Inflammation
• Interventions: Behavioral: Exercise and diet

• Registration Number: NCT01554735
• Lead Sponsor: Changi General Hospital

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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-15
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lifestyle counselling	Exercise and diet	exercise and diet counselling for weight loss

Primary Outcome Measures

Name	Time	Method
erectile function	24 weeks	Increase in IIEF-5 score

Secondary Outcome Measures

Name	Time	Method
lower urinary tract symptoms	24 weeks	decrease in IPSS score

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore