Lifestyle Modification for Erectile Dysfunction in Men With Metabolic Syndrome (NCT07758842) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Lifestyle Modification for Erectile Dysfunction in Men With Metabolic Syndrome
55 participantsStarted 2026-08-25
Plain-language 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.
Who can participate
Age range
30 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in penile peak systolic velocity from baseline to six months
Timeframe: Baseline and six months after initiation of the lifestyle-modification program.