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Effects of Lifestyle-modification Induced Weight Loss on Sexual and Urinary Function, 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: NCT01554735
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : July 29, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Sexual Dysfunction Endothelial Dysfunction Quality of Life Inflammation Behavioral: Exercise and diet Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2010
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. erectile function [ Time Frame: 24 weeks ]
    Increase in IIEF-5 score


Secondary Outcome Measures :
  1. lower urinary tract symptoms [ Time Frame: 24 weeks ]
    decrease in 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): NCT01554735


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Changi General Hospital
ClinicalTrials.gov Identifier: NCT01554735     History of Changes
Other Study ID Numbers: 12200233
First Posted: March 15, 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
Weight Loss
Pathologic Processes
Body Weight Changes
Body Weight
Signs and Symptoms