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Not Yet Recruiting NCT07758842

Lifestyle Modification for Erectile Dysfunction in Men With Metabolic Syndrome

Conditions: Erectile Dysfunction, Metabolic Syndrome

Sex: Male
Ages: 30 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 55
Sponsor: Al-Azhar University

Summary

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

Inclusion Criteria: * 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. * Sexually active participants in a stable sexual relationship. * Willingness and ability to participate in the six-month lifestyle-modification program. * Ability to provide written informed consent. Exclusion Criteria: * 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. * Previous pelvic surgery or pelvic radiotherapy likely to affect erectile function. * Severe or unstable cardiovascular disease that precludes sexual activity or participation in exercise-based lifestyle modification. * Uncontrolled diabetes mellitus, defined in the protocol as HbA1c greater than 10%. * Uncontrolled hypertension despite medical therapy. * Severe renal or hepatic impairment. * Active malignancy or life expectancy of less than one year. * Major psychiatric illness, cognitive impairment, or inability to comply with study procedures or follow-up. * Inability or refusal to provide written informed consent.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07758842). StuddyBuddy aggregates publicly available trial information.