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Effects of Lifestyle-modification Induced Weight Loss on Sexual and Urinary Function, and Quality of Life in Obese Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Changi General Hospital
ClinicalTrials.gov Identifier:
NCT01554735
First received: March 1, 2012
Last updated: July 27, 2015
Last verified: July 2015

March 1, 2012
July 27, 2015
July 2010
June 2013   (final data collection date for primary outcome measure)
erectile function [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Increase in IIEF-5 score
Same as current
Complete list of historical versions of study NCT01554735 on ClinicalTrials.gov Archive Site
lower urinary tract symptoms [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
decrease in IPSS score
Same as current
Not Provided
Not Provided
 
Effects of Lifestyle-modification Induced Weight Loss on Sexual and Urinary Function, and Quality of Life in Obese Men
The Effects of Lifestyle-modification Induced Weight Loss on Metabolic and Inflammatory Profile, Endothelial, Sexual and Urinary Function, and Quality of Life in Obese Men
This study aims to evaluate the extent to which weight loss of 5-10% from baseline, induced by exercise and diet, improves metabolic and inflammatory profile, endothelial function, erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life in obese men.
This study aims to evaluate the extent to which weight loss of 5-10% from baseline, induced by exercise and diet, improves metabolic and inflammatory profile, endothelial function, erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life in obese men.Men aged 30-65 years, with body mass index (BMI) ≥ 27.5 kg/m2, will be recruited from referrals to the Sports Medicine Centre in Changi General Hospital. The study will be conducted at the Sports Medicine Centre by trained medical investigators, dieticians and sports trainers.At baseline, 12 and 24 weeks, fasting glucose and lipids, insulin, testosterone, sex-hormone binding globulin, serum C-reactive protein and interleukin-6 are measured, endothelial function is measured by the non-invasive EndoPAT method, and validated questionnaires administered to assess changes in erectile function, sexual desire, LUTS and quality of life
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sexual Dysfunction
  • Endothelial Dysfunction
  • Quality of Life
  • Inflammation
Behavioral: Exercise and diet
24 weeks of exercise and diet counselling
Other Names:
  • Diet advice
  • Exercise training
Experimental: lifestyle counselling
exercise and diet counselling for weight loss
Intervention: Behavioral: Exercise and diet
Khoo J, Tian HH, Tan B, Chew K, Ng CS, Leong D, Teo RC, Chen RY. Comparing effects of low- and high-volume moderate-intensity exercise on sexual function and testosterone in obese men. J Sex Med. 2013 Jul;10(7):1823-32. doi: 10.1111/jsm.12154.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
June 2013
June 2013   (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
 
NCT01554735
12200233
No
Not Provided
Not Provided
Changi General Hospital
Changi General Hospital
Not Provided
Principal Investigator: Joan J 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