Comparing Effects of Diet, With or Without Exercise, on Sexual, Urinary and Endothelial Function, Inflammatory Profile and Quality of Life in Obese Men

Phase 4

Completed

• Conditions: Sexual Dysfunction; Quality of Life; Inflammation; Endothelial Dysfunction
• Interventions: Behavioral: weight loss counselling

• Registration Number: NCT01642576
• Lead Sponsor: Changi General Hospital

Brief Summary

This study aims to compare the effects of 8 months of diet modification, with or without exercise, on weight loss, sexual, urinary and endothelial function, systemic inflammation and quality of life in obese men.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2012-07-13
• Study First Submitted QC: 2012-07-13
• Study First Posted: 2012-07-17
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 90

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
diet modification	weight loss counselling	counselling on caloric restriction and healthy eating
weight management program	weight loss counselling	dietician and sports trainer, physician counselling on weight loss

Primary Outcome Measures

Name	Time	Method
erectile function	8 months	IIEF-5 score

Secondary Outcome Measures

Name	Time	Method
lower urinary tract symptoms	8 months	IPSS score

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore