Status:
COMPLETED
Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial
Lead Sponsor:
University of Campania Luigi Vanvitelli
Conditions:
Erectile Dysfunction
Eligibility:
MALE
35-55 years
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2003
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00636688
Start Date
October 1 2000
End Date
October 1 2003
Last Update
April 18 2008
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