Lifestyle Modification for Erectile Dysfunction in Men With Metabolic Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age30-65
SponsorAl-Azhar University
About this trial
Metabolic syndrome is associated with erectile dysfunction through obesity, insulin resistance, abnormal blood lipids, high blood pressure, and impaired blood-vessel function. This study will evaluate whether a structured six-month lifestyle-modification program can improve penile blood flow and erectile function in men with metabolic syndrome-associated erectile dysfunction.
Eligible participants will receive dietary counseling, exercise guidance, weight-management advice, smoking-cessation counseling when applicable, sleep and sedentary-behavior advice, and repeated behavioral reinforcement. Erectile function, penile blood-flow measurements obtained by penile duplex Doppler ultrasonography, body measurements, and selected metabolic laboratory parameters will be assessed before the program and after six months.
Eligibility criteria
Qualifiers
Men aged 30-65 years.
Erectile dysfunction present for at least six months.
International Index of Erectile Function-5 score of 21 or less.
Metabolic syndrome diagnosed according to the International Diabetes Federation criteria.
Disqualifiers
Erectile dysfunction primarily attributable to neurogenic, psychogenic, hormonal, or postsurgical causes.
Severe hypogonadism requiring immediate testosterone-replacement therapy.
Use of phosphodiesterase type 5 inhibitors, intracavernosal injections, vacuum erection devices, or other erectile-dysfunction treatment that cannot be discontinued before baseline assessment.
Significant penile anatomical abnormality that may interfere with penile duplex Doppler assessment, including Peyronie disease.
Trial design
Treatments tested in this trial
- Structured Lifestyle Modification Program
Treatment groups
55 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov