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Lifestyle overhaul may restore penile blood flow in metabolic syndrome

NCT ID NCT07758842

Disease control Sponsor: Al-Azhar University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This trial tests whether a structured six-month lifestyle modification program can improve penile blood flow and erectile function in men with metabolic syndrome-associated erectile dysfunction. Participants receive dietary counseling, exercise guidance, weight management, smoking cessation support, and sleep and sedentary behavior advice. Erectile function and penile blood flow are measured before and after the program to see if lifestyle changes can help.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A structured lifestyle modification program including diet, exercise, weight management, smoking cessation, sleep hygiene, and reduced sedentary behavior.
What this could lead to
If successful, this could establish a drug-free, lifestyle-based approach to improving erectile function and blood flow in men with metabolic syndrome.
What could go wrong
This is a small, single-arm study without a control group, so results may be influenced by placebo effects or natural variation. Adherence to lifestyle changes can be challenging, and benefits may not persist long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 55 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 65 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome erectile dysfunction metabolic syndrome X

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erectile dysfunction Metabolic syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Al-Hussein University Hospital, Al-Azhar University, Urology Department

    RECRUITING

    Cairo, 11633, Egypt

  • Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University

    RECRUITING

    Cairo, Egypt

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