Back to resultsEffects of Lifestyle-modification Induced Weight Loss on Sexual and Urinary Function, and Quality of Life in Obese Men
Primary Purpose
Sexual Dysfunction, Endothelial Dysfunction, Quality of Life
Status
Completed
Phase
Phase 4
Locations
Singapore
Study Type
Interventional
Intervention
Exercise and diet
Sponsored by
About this trial
This is an interventional treatment trial for Sexual Dysfunction focused on measuring obesity, men, sexual function, urinary tract symptoms, endothelial function, inflammation, quality of life
Eligibility 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
Sites / Locations
- Changi General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
lifestyle counselling
Arm Description
exercise and diet counselling for weight loss
Outcomes
Primary Outcome Measures
erectile function
Increase in IIEF-5 score
Secondary Outcome Measures
lower urinary tract symptoms
decrease in IPSS score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01554735
Brief Title
Effects of Lifestyle-modification Induced Weight Loss on Sexual and Urinary Function, and Quality of Life in Obese Men
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 Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changi General Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Endothelial Dysfunction, Quality of Life, Inflammation
Keywords
obesity, men, sexual function, urinary tract symptoms, endothelial function, inflammation, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lifestyle counselling
Arm Type
Experimental
Arm Description
exercise and diet counselling for weight loss
Intervention Type
Behavioral
Intervention Name(s)
Exercise and diet
Other Intervention Name(s)
Diet advice, Exercise training
Intervention Description
24 weeks of exercise and diet counselling
Primary Outcome Measure Information:
Title
erectile function
Description
Increase in IIEF-5 score
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
lower urinary tract symptoms
Description
decrease in IPSS score
Time Frame
24 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan J Khoo, MRCP
Organizational Affiliation
Changi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
23635309
Citation
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. Epub 2013 May 1.
Results Reference
derived
Learn more about this trial
Effects of Lifestyle-modification Induced Weight Loss on Sexual and Urinary Function, and Quality of Life in Obese Men
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