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

University of Campania Luigi Vanvitelli110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

110

Conditions

Erectile Dysfunction

Interventions

Eligibility

Sex: MALEMin age: 35 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

IIEF (International Index Erectile Function)

Time frame: two years

Secondary Outcomes

Endothelial function, Circulating inflammatory markers

Time frame: two years