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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01642576
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : July 29, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2010
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. erectile function [ Time Frame: 8 months ]
    IIEF-5 score


Secondary Outcome Measures :
  1. lower urinary tract symptoms [ Time Frame: 8 months ]
    IPSS score


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01642576


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

Responsible Party: Changi General Hospital
ClinicalTrials.gov Identifier: NCT01642576     History of Changes
Other Study ID Numbers: ZCHOENFU
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015

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