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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Changi General Hospital
ClinicalTrials.gov Identifier:
NCT01642576
First received: July 13, 2012
Last updated: July 27, 2015
Last verified: July 2015

July 13, 2012
July 27, 2015
July 2010
April 2014   (final data collection date for primary outcome measure)
erectile function [ Time Frame: 8 months ] [ Designated as safety issue: No ]
IIEF-5 score
Same as current
Complete list of historical versions of study NCT01642576 on ClinicalTrials.gov Archive Site
lower urinary tract symptoms [ Time Frame: 8 months ] [ Designated as safety issue: No ]
IPSS score
Same as current
Not Provided
Not Provided
 
Comparing Effects of Diet, With or Without Exercise, on Sexual, Urinary and Endothelial Function, Inflammatory Profile and Quality of Life in Obese Men
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 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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sexual Dysfunction
  • Endothelial Dysfunction
  • Quality of Life
  • Inflammation
Behavioral: weight loss counselling
Diet counselling with or without sports trainers, over 8 months
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Male
30 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01642576
ZCHOENFU
No
Not Provided
Not Provided
Changi General Hospital
Changi General Hospital
Not Provided
Principal Investigator: Joan Khoo, MRCP Changi General Hospital
Changi General Hospital
July 2015

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