Lifestyle Modification for Erectile Dysfunction in Men With Metabolic Syndrome

Sponsor
Al-Azhar University
Study ID
NCT07758842
Status
Recruiting
Apply to this trial

Conditions

  • Erectile Dysfunction
  • Metabolic Syndrome

Eligibility Criteria

Sex
MALE
Age
30 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Structured Lifestyle Modification Program — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Aug 11, 2026
Start date
Aug 13, 2026
Status verified
Aug 2026
Primary completion
Jul 24, 2027
Completion
Nov 24, 2027

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Structured Lifestyle Modification
    Participants will receive a structured six-month lifestyle-modification program consisting of dietary counseling, moderate-intensity physical-activity advice, weight-management counseling, smoking-cessation counseling when applicable, sleep-hygiene advice, reduction of sedentary behavior, and monthly behavioral reinforcement.

Primary Outcome Measure

Change in penile peak systolic velocity from baseline to six months [ Time Frame: Baseline and six months after initiation of the lifestyle-modification program. ]

Central Contacts

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