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

This study has been completed.
Sponsor:
Information provided by:
Second University of Naples
ClinicalTrials.gov Identifier:
NCT00636688
First received: February 26, 2008
Last updated: April 17, 2008
Last verified: March 2008
  Purpose

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 Intervention
Erectile Dysfunction
Behavioral: Lifestyle - detailed advice
Behavioral: Control - general information

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Second University of Naples:

Primary Outcome Measures:
  • IIEF (International Index Erectile Function) [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endothelial function, Circulating inflammatory markers [ Time Frame: two years ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: October 2000
Study Completion Date: October 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Control group
Behavioral: Control - general information
General information about healthy food choices and exercise

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00636688

Sponsors and Collaborators
Second University of Naples
Investigators
Study Director: Dario Giugliano, MD,PhD Department of Geriatrics and Metabolic Diseases, SUN Naples, Italy
  More Information

Publications:
Responsible Party: Dario Giugliano, MD,PhD, Department of Geriatrics and Metabolic Diseases, SUN Naples, Italy
ClinicalTrials.gov Identifier: NCT00636688     History of Changes
Other Study ID Numbers: 05/2000
Study First Received: February 26, 2008
Last Updated: April 17, 2008
Health Authority: Italy: Ethics Committee

Keywords provided by Second University of Naples:
Obesity
Lifestyle changes

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014