Lifestyle Modification for Erectile Dysfunction in Men With Metabolic Syndrome (LIFE-MetS-ED)
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
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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
This prospective single-arm interventional study will evaluate the effect of a structured six-month lifestyle-modification program on penile hemodynamic parameters and erectile function in adult men with metabolic syndrome-associated erectile dysfunction.
Participants will undergo baseline assessment including demographic and clinical data collection, anthropometric measurements, blood-pressure assessment, erectile-function evaluation using the International Index of Erectile Function-5, selected laboratory investigations, and penile duplex Doppler ultrasonography after intracavernosal administration of a vasoactive agent according to the local institutional protocol.
The lifestyle program will include individualized dietary counseling, recommendations for regular moderate-intensity aerobic physical activity, weight-reduction advice, smoking-cessation counseling for smokers, sleep-hygiene counseling, reduction of sedentary behavior, and behavioral reinforcement during follow-up visits. Participants will be followed monthly for adherence reinforcement and will undergo repeat clinical, laboratory, erectile-function, and penile hemodynamic assessments at six months.
The principal hypothesis is that structured lifestyle modification will improve penile hemodynamic parameters, particularly peak systolic velocity, and will improve erectile-function scores in men with metabolic syndrome-associated erectile dysfunction.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Abul-fotouh Ahmed, MD
- Numer telefonu: 00201001066756
- E-mail: abulfotouhahmed7070@gmail.com
Lokalizacje studiów
-
-
-
Cairo, Egipt, 11633
- Rekrutacyjny
- Al-Hussein University Hospital, Al-Azhar University, Urology Department
-
Kontakt:
- Abul-fotouh Ahmed
- E-mail: abulfotouhahmed7070@gmail.com
-
Cairo, Egipt
- Rekrutacyjny
- Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
-
Kontakt:
- Abul-fotouh Ahmed
- Numer telefonu: +201001066756
- E-mail: abulfotouhahmed@yahoo.com
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in penile peak systolic velocity from baseline to six months
Ramy czasowe: Baseline and six months after initiation of the lifestyle-modification program.
|
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.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in resistive index
Ramy czasowe: Baseline and six months.
|
Change in penile resistive index calculated from penile duplex Doppler measurements.
|
Baseline and six months.
|
|
Change in body weight
Ramy czasowe: Baseline and six months.
|
Change in body weight measured in kilograms.
|
Baseline and six months.
|
|
Change in waist circumference
Ramy czasowe: Baseline and six months.
|
Change in waist circumference measured in centimeters using a standardized measurement method.
|
Baseline and six months.
|
|
Change in end-diastolic velocity
Ramy czasowe: Baseline and six months.
|
Change in the total score of the International Index of Erectile Function-5 (IIEF-5) questionnaire from baseline to 6 months.
The IIEF-5 total score ranges from 5 to 25, with higher scores indicating better erectile function and lower scores indicating greater erectile dysfunction.
|
Baseline and six months.
|
|
Change in International Index of Erectile Function-5 / Sexual Health Inventory
Ramy czasowe: Baseline and six months
|
Change in total score from baseline to 6 months.
Score range 5-25; higher scores indicate better erectile function.
|
Baseline and six months
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Abul-fotouh Ahmed, MD, Al-Azhar University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Choroby układu moczowo-płciowego
- Choroby narządów płciowych
- Zaburzenia psychiczne
- Choroby narządów płciowych, mężczyzna
- Choroby układu moczowo-płciowego u mężczyzn
- Choroby metaboliczne
- Zaburzenia metabolizmu glukozy
- Insulinooporność
- Hiperinsulinizm
- Zaburzenia seksualne, fizjologiczne
- Dysfunkcje seksualne, psychologiczne
- Choroby żywieniowe i metaboliczne
- Syndrom metabliczny
- Zaburzenie erekcji
Inne numery identyfikacyjne badania
- UroAzhar_14_026
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .