Lifestyle Modification for Erectile Dysfunction in Men With Metabolic Syndrome

NCT07758842 | Not Yet Recruiting

• 1 other identifier: UroAzhar_14_026
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Erectile Dysfunction; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in penile peak systolic velocity from baseline to six months

  Change in peak systolic velocity measured in centimeters per second by penile duplex Doppler ultrasonography after intracavernosal vasoactive-agent administration, comparing the baseline value with the six-month post-intervention value.

  Baseline and six months after initiation of the lifestyle-modification program.

Secondary Outcomes (5)

• Change in erectile-function score

  Baseline and six months

• Change in end-diastolic velocity

  Baseline and six months.

• Change in resistive index

  Baseline and six months.

• Change in body weight

  Baseline and six months.

• Change in waist circumference

  Baseline and six months.

Study Arms (1)

Structured Lifestyle Modification

EXPERIMENTAL

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.

Behavioral: Structured Lifestyle Modification Program

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.

Structured Lifestyle Modification

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

MeSH Terms

Conditions

Erectile Dysfunction; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Abul-fotouh Ahmed, MD

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abul-fotouh Ahmed

CONTACT

00201001066756; abulfotouhahmed7070@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Model Details: Participants will undergo a structured six-month lifestyle-modification program consisting of dietary counseling, advice regarding moderate-intensity aerobic physical activity, weight-management counseling, smoking-cessation counseling when applicable, sleep-hygiene advice, reduction of sedentary behavior, and behavioral reinforcement during follow-up visits.

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): August 25, 2026
• Primary Completion (Estimated): July 24, 2027
• Study Completion (Estimated): November 24, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08