Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

29 avril 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

60

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Médicament: Tadalafil 5 mg
Tadalafil 5 mg once daily for three months
Expérimental: 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.
Médicament: SGLT-2 inhibitor
SGLT2 inhibitors 10 mg orally once daily for three months
Autres noms:
  • Dapagliflozine
  • Empagliflozine
Expérimental: 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.
Médicament: Tadalafil plus SGLT2 inhibitors
Combination therapy with tadalafil 5 mg once daily and SGLT2 inhibitors 10 mg once daily for three months

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in erectile function assessed by the International Index of Erectile Function (IIEF)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in left ventricular diastolic function assessed by echocardiographic parameters
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Kafrelsheikh University

Les enquêteurs

  • Chaise d'étude: Reda B Bastawisy, MD (Professor), Faculty of medicine, Kafrelshiekh university
  • Chaise d'étude: Wael A Haseeb, MD (Assistant professor), Faculty of medicine, Kafrelshiekh university
  • Chaise d'étude: Mohamed G Abdelraouf, MD, Faculty of medicine, Kafrelshiekh university

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

5 mai 2025

Achèvement primaire (Réel)

17 mars 2026

Achèvement de l'étude (Réel)

17 mars 2026

Dates d'inscription aux études

Première soumission

21 avril 2026

Première soumission répondant aux critères de contrôle qualité

29 avril 2026

Première publication (Réel)

4 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • METDDED-01
  • PACTR202604903325533 (Identificateur de registre: Pan African Clinical Trials Registry (PACTR))

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage IPD

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

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner