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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Changi General Hospital.
Recruitment status was  Recruiting
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
  Purpose

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.


Condition Intervention Phase
Sexual Dysfunction
Endothelial Dysfunction
Quality of Life
Inflammation
Behavioral: weight loss counselling
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Changi General Hospital:

Primary Outcome Measures:
  • erectile function [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    IIEF-5 score


Secondary Outcome Measures:
  • lower urinary tract symptoms [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    IPSS score


Estimated Enrollment: 80
Study Start Date: July 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: diet modification
counselling on caloric restriction and healthy eating
Behavioral: weight loss counselling
Diet counselling with or without sports trainers, over 8 months
Experimental: weight management program
dietician and sports trainer, physician counselling on weight loss
Behavioral: weight loss counselling
Diet counselling with or without sports trainers, over 8 months

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642576

Contacts
Contact: Joan Khoo, MRCP +6581211542 joan_khoo@cgh.com.sg

Locations
Singapore
Changi General Hospital Recruiting
Singapore, Singapore, 529889
Principal Investigator: Joan Khoo, MRCP         
Sponsors and Collaborators
Changi General Hospital
Investigators
Principal Investigator: Joan Khoo, MRCP Changi General Hospital
  More Information

No publications provided

Responsible Party: Changi General Hospital
ClinicalTrials.gov Identifier: NCT01642576     History of Changes
Other Study ID Numbers: ZCHOENFU
Study First Received: July 13, 2012
Last Updated: July 13, 2012
Health Authority: Singapore: Ministry of Health

Keywords provided by Changi General Hospital:
obesity
men
sexual function
urinary tract symptoms
endothelial function
inflammation
quality of life

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014