Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Erectile Dysfunction
• Interventions: Behavioral: Lifestyle - detailed advice; Behavioral: Control - general information

• Registration Number: NCT00636688
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-10
• Primary Completion: 2003-04
• Study Completion: 2003-10
• Study First Submitted: 2008-02-26
• Status Verified: 2008-03
• Study First Submitted QC: 2008-03-07
• Study First Posted: 2008-03-14
• Last Update Submitted: 2008-04-17
• Last Update Posted: 2008-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 110

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lifestyle - detailed advice	Behavioral (Lifestyle Counseling)
2	Control - general information	Control group

Primary Outcome Measures

Name	Time	Method
IIEF (International Index Erectile Function)	two years

Secondary Outcome Measures

Name	Time	Method
Endothelial function, Circulating inflammatory markers	two years