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

NCT00636688 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2008-04-18

No results posted yet for this study

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.

Conditions

Interventions

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

BEHAVIORAL

Control - general information

General information about healthy food choices and exercise

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Principal Investigators

  • Dario Giugliano, MD,PhD · Department of Geriatrics and Metabolic Diseases, SUN Naples, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-10-31
Primary Completion
2003-04-30
Completion
2003-10-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00636688 on ClinicalTrials.gov