Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00636688
Enrollment
110
Registered
2008-03-14
Start date
2000-10-31
Completion date
2003-10-31
Last updated
2008-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Obesity, Lifestyle changes

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.

Interventions

BEHAVIORALLifestyle - 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

General information about healthy food choices and exercise

Sponsors

University of Campania Luigi Vanvitelli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
35 Years to 55 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frame
IIEF (International Index Erectile Function)two years

Secondary

MeasureTime frame
Endothelial function, Circulating inflammatory markerstwo years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026