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

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle - detailed advice
Control - general information
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Obesity, Lifestyle changes

Eligibility Criteria

35 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Behavioral (Lifestyle Counseling)

    Control group

    Outcomes

    Primary Outcome Measures

    IIEF (International Index Erectile Function)

    Secondary Outcome Measures

    Endothelial function, Circulating inflammatory markers

    Full Information

    First Posted
    February 26, 2008
    Last Updated
    April 17, 2008
    Sponsor
    University of Campania "Luigi Vanvitelli"
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00636688
    Brief Title
    Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial
    Official Title
    Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2000 (undefined)
    Primary Completion Date
    April 2003 (Actual)
    Study Completion Date
    October 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Campania "Luigi Vanvitelli"

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Erectile Dysfunction
    Keywords
    Obesity, Lifestyle changes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    110 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Behavioral (Lifestyle Counseling)
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Control group
    Intervention Type
    Behavioral
    Intervention Name(s)
    Lifestyle - detailed advice
    Intervention Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control - general information
    Intervention Description
    General information about healthy food choices and exercise
    Primary Outcome Measure Information:
    Title
    IIEF (International Index Erectile Function)
    Time Frame
    two years
    Secondary Outcome Measure Information:
    Title
    Endothelial function, Circulating inflammatory markers
    Time Frame
    two years

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dario Giugliano, MD,PhD
    Organizational Affiliation
    Department of Geriatrics and Metabolic Diseases, SUN Naples, Italy
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12899583
    Citation
    Bacon CG, Mittleman MA, Kawachi I, Giovannucci E, Glasser DB, Rimm EB. Sexual function in men older than 50 years of age: results from the health professionals follow-up study. Ann Intern Med. 2003 Aug 5;139(3):161-8. doi: 10.7326/0003-4819-139-3-200308050-00005.
    Results Reference
    background
    PubMed Identifier
    15213209
    Citation
    Esposito K, Giugliano F, Di Palo C, Giugliano G, Marfella R, D'Andrea F, D'Armiento M, Giugliano D. Effect of lifestyle changes on erectile dysfunction in obese men: a randomized controlled trial. JAMA. 2004 Jun 23;291(24):2978-84. doi: 10.1001/jama.291.24.2978.
    Results Reference
    result

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

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