Back to resultsComparing Effects of Diet, With or Without Exercise, on Sexual, Urinary and Endothelial Function, Inflammatory Profile 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
weight loss counselling
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 2
Arm Type
Experimental
Experimental
Arm Label
diet modification
weight management program
Arm Description
counselling on caloric restriction and healthy eating
dietician and sports trainer, physician counselling on weight loss
Outcomes
Primary Outcome Measures
erectile function
IIEF-5 score
Secondary Outcome Measures
lower urinary tract symptoms
IPSS score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01642576
Brief Title
Comparing Effects of Diet, With or Without Exercise, on Sexual, Urinary and Endothelial Function, Inflammatory Profile and Quality of Life in Obese Men
Official Title
Comparing Effects of Diet, With or Without Exercise, on Sexual, Urinary and Endothelial Function, Inflammatory Profile 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
April 2014 (Actual)
Study Completion Date
April 2014 (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 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.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
diet modification
Arm Type
Experimental
Arm Description
counselling on caloric restriction and healthy eating
Arm Title
weight management program
Arm Type
Experimental
Arm Description
dietician and sports trainer, physician counselling on weight loss
Intervention Type
Behavioral
Intervention Name(s)
weight loss counselling
Intervention Description
Diet counselling with or without sports trainers, over 8 months
Primary Outcome Measure Information:
Title
erectile function
Description
IIEF-5 score
Time Frame
8 months
Secondary Outcome Measure Information:
Title
lower urinary tract symptoms
Description
IPSS score
Time Frame
8 months
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 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
Learn more about this trial
Comparing Effects of Diet, With or Without Exercise, on Sexual, Urinary and Endothelial Function, Inflammatory Profile and Quality of Life in Obese Men
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