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Association Between Diastolic Dysfunction and Erectile Dysfunction and the Effect of Tadalafil and SGLT2 Inhibitors on Them in Men With Metabolic Syndrome (METDDED)

29 aprile 2026 aggiornato da: Dr Ahmed Ibrahim Shoghy, Kafrelsheikh University

A Randomized, Allocation-concealed, Assessor-blinded, Parallel-group Trial Evaluating the Association Between Erectile Dysfunction and Left Ventricular Diastolic Dysfunction and Comparing the Effects of Tadalafil, SGLT2 Inhibitors, and Their Combination in Patients With Metabolic Syndrome.

Metabolic syndrome is associated with an increased risk of cardiovascular disease and is commonly accompanied by erectile dysfunction and subclinical cardiac dysfunction. Erectile dysfunction and left ventricular diastolic dysfunction may share common underlying mechanisms, including endothelial dysfunction and microvascular impairment.

This study aims to investigate the association between erectile dysfunction and left ventricular diastolic dysfunction in men with metabolic syndrome, and to evaluate the effects of different treatment strategies, including tadalafil and SGLT2 inhibitors, on both erectile function and cardiac diastolic function.

Participants will be randomly assigned to receive tadalafil, an SGLT2 inhibitor, or a combination of both for a duration of three months. Clinical, echocardiographic, and functional assessments will be performed at baseline and after treatment.

The results of this study may improve understanding of the link between cardiovascular and sexual dysfunction and help guide therapeutic approaches in this patient population.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a prospective, randomized, allocation-concealed, assessor-blinded, parallel-group clinical trial conducted at the Faculty of Medicine, Kafrelsheikh University. The study investigates the association between erectile dysfunction (ED) and left ventricular diastolic dysfunction (LVDD) in men with metabolic syndrome, and evaluates the effects of different treatment strategies on both conditions.

A total of 60 male patients aged 41 to 73 years diagnosed with metabolic syndrome and erectile dysfunction will be enrolled and randomly assigned into three parallel groups (1:1:1). The first group will receive tadalafil 5 mg once daily, the second group will receive an SGLT2 inhibitor (dapagliflozin or empagliflozin 10 mg once daily), and the third group will receive a combination of both treatments. The duration of intervention is 3 months.

Randomization will be performed using permuted block randomization, with allocation concealment ensured by an independent sequence holder. Outcome assessors will be blinded to treatment allocation.

Baseline and follow-up assessments will include clinical evaluation, metabolic parameters, echocardiographic assessment of left ventricular diastolic function, and evaluation of erectile function using the International Index of Erectile Function (IIEF).

The primary outcome is the change in erectile function as assessed by IIEF score after 3 months of treatment. Secondary outcomes include changes in echocardiographic parameters of diastolic function, correlation between erectile function and diastolic dysfunction, and identification of predictors of improvement in erectile function.

The study aims to provide insight into the relationship between cardiovascular dysfunction and erectile dysfunction in patients with metabolic syndrome and to determine whether combined therapy offers additional benefits over monotherapy.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Egitto
    • Kafrelsheikh Governrate
      • Kafr ash Shaykh, Kafrelsheikh Governrate, Egitto, 33511
        • Kafrelsheikh univeristy hospital, Faculty of medicine, Kafrelsheikh univeristy

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Male patients aged ≥18 years
  • History of sexual activity within the past 6 months
  • Erectile dysfunction for at least 3 months (defined as IIEF-6 score ≤25)
  • Diagnosed with metabolic syndrome

Exclusion Criteria:

  • * Left ventricular systolic dysfunction (EF less than 50%)

    • Recent myocardial infarction (within 1 month)
    • Moderate to severe valvular heart disease (stenosis or regurgitation)
    • Renal failure (eGFR <20 ml/min)
    • Major pelvic surgery
    • Significant central nervous system injury (e.g., spinal cord injury)
    • Endocrine disorders (hypothyroidism, hypogonadism)
    • Premature ejaculation
    • Current balanitis or urogenital infections
    • History of orthostatic hypotension
    • Any contraindications to tadalafil or SGLT2 inhibitors

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Tadalafil Group
Participants received tadalafil 5 mg orally once daily for 3 months. Erectile function, left ventricular diastolic function, and metabolic parameters were assessed at baseline and after completion of treatment.
Droga: Tadalafil 5 mg
Tadalafil 5 mg once daily for three months
Sperimentale: SGLT2 inhibitors group
Participants received SGLT2 inhibitors (dapagliflozin or empagliflozin) 10 mg orally once daily for 3 months. Erectile function, left ventricular diastolic function, and metabolic parameters were assessed at baseline and after completion of treatment.
Droga: SGLT-2 inhibitor
SGLT2 inhibitors 10 mg orally once daily for three months
Altri nomi:
  • Dapagliflozin
  • Empagliflozin
Sperimentale: Combination therapy
Participants received combination therapy with tadalafil 5 mg once daily plus SGLT2 inhibitors 10 mg once daily for 3 months. Erectile function, left ventricular diastolic function, and metabolic parameters were assessed at baseline and after completion of treatment.
Droga: Tadalafil plus SGLT2 inhibitors
Combination therapy with tadalafil 5 mg once daily and SGLT2 inhibitors 10 mg once daily for three months

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in erectile function assessed by the International Index of Erectile Function (IIEF)
Lasso di tempo: Baseline and 3 months
Change in erectile function assessed by the International Index of Erectile Function (IIEF-6). The IIEF-6 is a validated questionnaire with scores ranging from 1 to 30, where higher scores indicate better erectile function. The outcome measure will be the change in IIEF-6 score from baseline to 3 months after treatment.
Baseline and 3 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in left ventricular diastolic function assessed by echocardiographic parameters
Lasso di tempo: Baseline and 3 months
Left ventricular diastolic function will be assessed using specific echocardiographic parameters in accordance with ASE/EACVI guidelines, including E/e' ratio, isovolumic relaxation time (IVRT, ms), deceleration time (DT, ms), and pulmonary artery systolic pressure (PASP, mmHg). Each parameter will be measured at baseline and at 3 months, and analyzed individually as components of overall diastolic function to evaluate changes over time.
Baseline and 3 months
Correlation between changes in IIEF score and echocardiographic parameters
Lasso di tempo: Baseline and 3 months
Correlation between changes in erectile function assessed by the International Index of Erectile Function (IIEF-6) score (range: 1-30, higher scores indicate better erectile function) and changes in selected echocardiographic parameters of left ventricular diastolic function, including E/e' ratio, isovolumic relaxation time (IVRT, ms), deceleration time (DT, ms), and pulmonary artery systolic pressure (PASP, mmHg).
Baseline and 3 months
Predictors of change in IIEF score
Lasso di tempo: Baseline and 3 months
Identification of independent predictors of change in erectile function assessed by the International Index of Erectile Function (IIEF-6) score (range: 1-30, higher scores indicate better erectile function). Predictors include selected clinical variables (age, years; smoking status, categorical), metabolic parameters (waist circumference, cm; systolic and diastolic blood pressure, mmHg; fasting blood glucose, mg/dL; HDL cholesterol, mg/dL; triglycerides, mg/dL), and specific echocardiographic parameters (E/e' ratio, unitless; isovolumic relaxation time [IVRT], ms; deceleration time [DT], ms; pulmonary artery systolic pressure [PASP], mmHg).
Baseline and 3 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Kafrelsheikh University

Investigatori

  • Cattedra di studio: Reda B Bastawisy, MD (Professor), Faculty of medicine, Kafrelshiekh university
  • Cattedra di studio: Wael A Haseeb, MD (Assistant professor), Faculty of medicine, Kafrelshiekh university
  • Cattedra di studio: Mohamed G Abdelraouf, MD, Faculty of medicine, Kafrelshiekh university

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 maggio 2025

Completamento primario (Effettivo)

17 marzo 2026

Completamento dello studio (Effettivo)

17 marzo 2026

Date di iscrizione allo studio

Primo inviato

21 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

4 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • METDDED-01
  • PACTR202604903325533 (Identificatore di registro: Pan African Clinical Trials Registry (PACTR))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

De-identified individual participant data (including baseline characteristics, outcome measures, and relevant clinical variables) will be made available upon reasonable request after publication of the study results.

Periodo di condivisione IPD

Data will be available starting 6 months after publication and will remain available for up to 2 years.

Criteri di accesso alla condivisione IPD

Access will be granted to qualified researchers upon reasonable request, subject to approval by the principal investigator and institutional ethics committee, and after signing a data sharing agreement.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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