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

Study Overview
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Brief Summary
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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.

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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Behavioral: Lifestyle - detailed advice
* Behavioral: Control - general information


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Behavioral (Lifestyle Counseling) | Behavioral: Lifestyle - detailed advice<br>* 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<br>|
| Active Comparator: 2<br>Control group | Behavioral: Control - general information<br>* General information about healthy food choices and exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IIEF (International Index Erectile Function) |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function, Circulating inflammatory markers |  | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Lifestyle changes