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

This study is currently recruiting participants.

Verified July 2012 by Changi General Hospital

Sponsor:

Information provided by (Responsible Party):

Changi General Hospital

ClinicalTrials.gov Identifier:

NCT01642576

First received: July 13, 2012

Last updated: NA

Last verified: July 2012

History: No changes posted

Tracking Information

First Received Date ^ICMJE

July 13, 2012

Last Updated Date

July 13, 2012

Start Date ^ICMJE

July 2010

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

erectile function [ Time Frame: 8 months ] [ Designated as safety issue: No ]

IIEF-5 score

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

lower urinary tract symptoms [ Time Frame: 8 months ] [ Designated as safety issue: No ]

IPSS score

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Sexual Dysfunction
Endothelial Dysfunction
Quality of Life
Inflammation

Intervention ^ICMJE

Behavioral: weight loss counselling

Diet counselling with or without sports trainers, over 8 months

Study Arm (s)

Experimental: diet modification
counselling on caloric restriction and healthy eating

Intervention: Behavioral: weight loss counselling
Experimental: weight management program
dietician and sports trainer, physician counselling on weight loss

Intervention: Behavioral: weight loss counselling

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2012

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

30 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Joan Khoo, MRCP

+6581211542

joan_khoo@cgh.com.sg

Location Countries ^ICMJE

Singapore

Administrative Information

NCT Number ^ICMJE

NCT01642576

Other Study ID Numbers ^ICMJE

ZCHOENFU

Has Data Monitoring Committee

Responsible Party

Changi General Hospital

Study Sponsor ^ICMJE

Changi General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Joan Khoo, MRCP

Changi General Hospital

Information Provided By

Changi General Hospital

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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