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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 is currently recruiting participants.
Verified March 2012 by Changi General Hospital
Sponsor:
Information provided by (Responsible Party):
Changi General Hospital
ClinicalTrials.gov Identifier:
NCT01554735
First received: March 1, 2012
Last updated: March 13, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Sexual Dysfunction
Endothelial Dysfunction
Quality of Life
Inflammation
 Behavioral: Exercise and diet
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Changi General Hospital:

Primary Outcome Measures:
  • erectile function [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Increase in IIEF-5 score


Secondary Outcome Measures:
  • lower urinary tract symptoms [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    decrease in IPSS score


Estimated Enrollment: 100
Study Start Date: July 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lifestyle counselling
exercise and diet counselling for weight loss
 Behavioral: Exercise and diet
24 weeks of exercise and diet counselling
Other Names:
  • Diet advice
  • Exercise training

Detailed Description:

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

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554735

Contacts
Contact: Joan J Khoo, MRCP +6581211542 furrina_2000@yahoo.com

Locations
Singapore
Changi General Hospital Recruiting
Singapore, Singapore, 529889
Contact: Joan Khoo, MRCP     +6581211542     furrina_2000@yahoo.com    
Principal Investigator: Joan J Khoo, MRCP            
Sponsors and Collaborators
Changi General Hospital
Investigators
Principal Investigator: Joan J Khoo, MRCP Changi General Hospital
  More Information

No publications provided

Responsible Party: Changi General Hospital
ClinicalTrials.gov Identifier: NCT01554735     History of Changes
Other Study ID Numbers: 12200233
Study First Received: March 1, 2012
Last Updated: March 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
Sexual Dysfunctions, Psychological
Weight Loss
Pathologic Processes
Sexual and Gender Disorders
 Mental Disorders
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013