Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle - detailed advice
Control - general information
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Obesity, Lifestyle changes
Eligibility Criteria
Inclusion Criteria:
- Obese, sedentary (<1 hour per week of physical activity) men with erectile dysfunction (a IIEF score lower than 22)and no evidence of participation in diet reduction programs within the last 6 months
Exclusion Criteria:
- Diabetes mellitus or impaired glucose tolerance (plasma glucose levels of 140-200 mg/dL [7.8-11.1 mmol/L] 2 hours after a 75-g oral glucose load)
- Impaired renal function, including macroalbuminuria, pelvic trauma, prostatic disease, peripheral or autonomic neuropathy
- Hypertension (blood pressure >140/90 mm Hg)
- Cardiovascular disease
- Psychiatric problems
- Use of drugs or alcohol abuse (500 g of alcohol per week in the last year).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Behavioral (Lifestyle Counseling)
Control group
Outcomes
Primary Outcome Measures
IIEF (International Index Erectile Function)
Secondary Outcome Measures
Endothelial function, Circulating inflammatory markers
Full Information
NCT ID
NCT00636688
First Posted
February 26, 2008
Last Updated
April 17, 2008
Sponsor
University of Campania "Luigi Vanvitelli"
1. Study Identification
Unique Protocol Identification Number
NCT00636688
Brief Title
Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial
Official Title
Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
October 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Campania "Luigi Vanvitelli"
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Healthy lifestyle factors are associated with maintenance of erectile function in men. To determine the effect of weight loss and increased physical activity on erectile and endothelial functions in obese men.
Randomized, single-blind trial of 110 obese men without diabetes, hypertension, or hyperlipidemia, who had erectile dysfunction that was determined by having a score of 21 or less on the International Index of Erectile Function (IIEF).
The 55 men randomly assigned to the intervention group received detailed advice about how to achieve a loss of 10% or more in their total body weight by reducing caloric intake and increasing their level of physical activity. Men in the control group (n = 55) were given general information about healthy food choices and exercise.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Obesity, Lifestyle changes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Behavioral (Lifestyle Counseling)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Control group
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle - detailed advice
Intervention Description
Detailed advice about how to achieve a loss of 10% or more in their total body weight by reducing caloric intake and increasing their level of physical activity
Intervention Type
Behavioral
Intervention Name(s)
Control - general information
Intervention Description
General information about healthy food choices and exercise
Primary Outcome Measure Information:
Title
IIEF (International Index Erectile Function)
Time Frame
two years
Secondary Outcome Measure Information:
Title
Endothelial function, Circulating inflammatory markers
Time Frame
two years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Obese, sedentary (<1 hour per week of physical activity) men with erectile dysfunction (a IIEF score lower than 22)and no evidence of participation in diet reduction programs within the last 6 months
Exclusion Criteria:
Diabetes mellitus or impaired glucose tolerance (plasma glucose levels of 140-200 mg/dL [7.8-11.1 mmol/L] 2 hours after a 75-g oral glucose load)
Impaired renal function, including macroalbuminuria, pelvic trauma, prostatic disease, peripheral or autonomic neuropathy
Hypertension (blood pressure >140/90 mm Hg)
Cardiovascular disease
Psychiatric problems
Use of drugs or alcohol abuse (500 g of alcohol per week in the last year).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dario Giugliano, MD,PhD
Organizational Affiliation
Department of Geriatrics and Metabolic Diseases, SUN Naples, Italy
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
12899583
Citation
Bacon CG, Mittleman MA, Kawachi I, Giovannucci E, Glasser DB, Rimm EB. Sexual function in men older than 50 years of age: results from the health professionals follow-up study. Ann Intern Med. 2003 Aug 5;139(3):161-8. doi: 10.7326/0003-4819-139-3-200308050-00005.
Results Reference
background
PubMed Identifier
15213209
Citation
Esposito K, Giugliano F, Di Palo C, Giugliano G, Marfella R, D'Andrea F, D'Armiento M, Giugliano D. Effect of lifestyle changes on erectile dysfunction in obese men: a randomized controlled trial. JAMA. 2004 Jun 23;291(24):2978-84. doi: 10.1001/jama.291.24.2978.
Results Reference
result
Learn more about this trial
Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial
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