Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT00636688|
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : April 18, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction||Behavioral: Lifestyle - detailed advice Behavioral: Control - general information||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial.|
|Study Start Date :||October 2000|
|Actual Primary Completion Date :||April 2003|
|Actual Study Completion Date :||October 2003|
Behavioral (Lifestyle Counseling)
Behavioral: Lifestyle - detailed advice
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
Active Comparator: 2
Behavioral: Control - general information
General information about healthy food choices and exercise
- IIEF (International Index Erectile Function) [ Time Frame: two years ]
- Endothelial function, Circulating inflammatory markers [ Time Frame: two years ]
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): NCT00636688
|Study Director:||Dario Giugliano, MD,PhD||Department of Geriatrics and Metabolic Diseases, SUN Naples, Italy|