NCT00636688

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2000

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2008

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
Last Updated

April 18, 2008

Status Verified

March 1, 2008

Enrollment Period

2.5 years

First QC Date

February 26, 2008

Last Update Submit

April 17, 2008

Conditions

Erectile Dysfunction

Keywords

ObesityLifestyle changes

Outcome Measures

Primary Outcomes (1)

  • IIEF (International Index Erectile Function)

    two years

Secondary Outcomes (1)

  • Endothelial function, Circulating inflammatory markers

    two years

Study Arms (2)

1

EXPERIMENTAL

Behavioral (Lifestyle Counseling)

Behavioral: Lifestyle - detailed advice

2

ACTIVE COMPARATOR

Control group

Behavioral: Control - general information

Interventions

Lifestyle - detailed adviceBEHAVIORAL

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

1
Control - general informationBEHAVIORAL

General information about healthy food choices and exercise

2

Eligibility Criteria

Age35 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 12899583BACKGROUND

  • 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.

    PMID: 15213209RESULT

MeSH Terms

Conditions

Erectile DysfunctionObesity

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dario Giugliano, MD,PhD

    Department of Geriatrics and Metabolic Diseases, SUN Naples, Italy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 26, 2008

First Posted

March 14, 2008

Study Start

October 1, 2000

Primary Completion

April 1, 2003

Study Completion

October 1, 2003

Last Updated

April 18, 2008

Record last verified: 2008-03