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NOT YET RECRUITING
NCT07758842
NA

Lifestyle Modification for Erectile Dysfunction in Men With Metabolic Syndrome

Sponsor: Al-Azhar University

View on ClinicalTrials.gov

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.

Official title: Penile Hemodynamic Recovery Following a Six-Month Structured Lifestyle Modification Program in Men With Metabolic Syndrome-Associated Erectile Dysfunction: A Prospective Single-Arm Interventional Study

Key Details

Gender

MALE

Age Range

30 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

55

Start Date

2026-08-25

Completion Date

2027-11-24

Last Updated

2026-08-11

Healthy Volunteers

No

Interventions

BEHAVIORAL

Structured Lifestyle Modification Program

Participants will receive an initial standardized counseling session followed by written lifestyle instructions and repeated monthly reinforcement. The program will target improved diet quality, reduced caloric intake, increased moderate-intensity aerobic activity, weight reduction according to baseline body mass index and waist circumference, smoking cessation when applicable, improved sleep hygiene, and reduced sedentary behavior. Adherence will be assessed using participant self-report and follow-up review over six months.