Association Between Diastolic Dysfunction and Erectile Dysfunction and the Effect of Tadalafil and SGLT2 Inhibitors on Them in Men With Metabolic Syndrome (METDDED)
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Kafrelsheikh Governrate
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Kafr ash Shaykh, Kafrelsheikh Governrate, Egipto, 33511
- Kafrelsheikh univeristy hospital, Faculty of medicine, Kafrelsheikh univeristy
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
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Tadalafil 5 mg once daily for three months
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Experimental: 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.
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SGLT2 inhibitors 10 mg orally once daily for three months
Otros nombres:
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Experimental: 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.
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Combination therapy with tadalafil 5 mg once daily and SGLT2 inhibitors 10 mg once daily for three months
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in erectile function assessed by the International Index of Erectile Function (IIEF)
Periodo de tiempo: Baseline and 3 months
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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.
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Baseline and 3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in left ventricular diastolic function assessed by echocardiographic parameters
Periodo de tiempo: Baseline and 3 months
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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.
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Baseline and 3 months
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Correlation between changes in IIEF score and echocardiographic parameters
Periodo de tiempo: Baseline and 3 months
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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).
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Baseline and 3 months
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Predictors of change in IIEF score
Periodo de tiempo: Baseline and 3 months
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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).
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Baseline and 3 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Reda B Bastawisy, MD (Professor), Faculty of medicine, Kafrelshiekh university
- Silla de estudio: Wael A Haseeb, MD (Assistant professor), Faculty of medicine, Kafrelshiekh university
- Silla de estudio: Mohamed G Abdelraouf, MD, Faculty of medicine, Kafrelshiekh university
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades cardiovasculares
- Desordenes mentales
- Enfermedades Genitales Masculinas
- Enfermedades urogenitales masculinas
- Enfermedades cardíacas
- Enfermedades metabólicas
- Trastornos del metabolismo de la glucosa
- Resistencia a la insulina
- Hiperinsulinismo
- Disfunción ventricular
- Disfunción Sexual Fisiológica
- Disfunciones Sexuales Psicológicas
- Enfermedades Nutricionales y Metabólicas
- Síndrome metabólico
- Disfunción Ventricular Izquierda
- Disfuncion erectil
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica.
- Agentes hipoglucemiantes
- Piridina
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Acciones farmacológicas
- Acciones y usos químicos
- Indoles
- Alcaloides de indol
- Compuestos heterocíclicos, 3 anillos
- Carbolines
- Tadalafilo
- Inhibidores del transportador de sodio-glucosa 2
- empagliflozin
- dapagliflozin
Otros números de identificación del estudio
- METDDED-01
- PACTR202604903325533 (Identificador de registro: Pan African Clinical Trials Registry (PACTR))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
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