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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642576
• Other study ID #: ZCHOENFU
• Status: Completed
• Phase: Phase 4
• First received: July 13, 2012
• Last updated: July 27, 2015
• Start date: July 2010
• Est. completion date: April 2014

Study information

• Verified date: July 2015
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Inflammation
• Quality of Life
• Sexual Dysfunction

Intervention

Behavioral:
• weight loss counselling
Diet counselling with or without sports trainers, over 8 months

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	erectile function	IIEF-5 score	8 months	No
Secondary	lower urinary tract symptoms	IPSS score	8 months	No