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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636688
• Other study ID #: 05/2000
• Status: Completed
• Phase: N/A
• First received: February 26, 2008
• Last updated: April 17, 2008
• Start date: October 2000
• Est. completion date: October 2003

Study information

• Verified date: March 2008
• Source: Second University of Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 2003
• Est. primary completion date: April 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

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
• Control - general information
General information about healthy food choices and exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second University of Naples

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IIEF (International Index Erectile Function)		two years	No
Secondary	Endothelial function, Circulating inflammatory markers		two years	No