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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Kafrelsheikh Governrate
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Kafr ash Shaykh, Kafrelsheikh Governrate, Egito, 33511
- Kafrelsheikh univeristy hospital, Faculty of medicine, Kafrelsheikh univeristy
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 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
Outros nomes:
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in erectile function assessed by the International Index of Erectile Function (IIEF)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in left ventricular diastolic function assessed by echocardiographic parameters
Prazo: 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
Prazo: 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
Prazo: 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
- Cadeira de estudo: Reda B Bastawisy, MD (Professor), Faculty of medicine, Kafrelshiekh university
- Cadeira de estudo: Wael A Haseeb, MD (Assistant professor), Faculty of medicine, Kafrelshiekh university
- Cadeira de estudo: Mohamed G Abdelraouf, MD, Faculty of medicine, Kafrelshiekh university
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Genitais
- Doenças cardiovasculares
- Transtornos Mentais, Desordem Mental
- Doenças Genitais, Masculino
- Doenças Urogenitais Masculinas
- Doenças cardíacas
- Doenças Metabólicas
- Distúrbios do Metabolismo da Glicose
- Resistência a insulina
- Hiperinsulinismo
- Disfunção Ventricular
- Disfunção Sexual Fisiológica
- Disfunções Sexuais, Psicológicas
- Doenças Nutricionais e Metabólicas
- Síndrome metabólica
- Disfunção Ventricular Esquerda
- Disfunção erétil
- Efeitos fisiológicos das drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes hipoglicemiantes
- Piridinas
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Compostos heterocíclicos, 2 anel
- Compostos heterocíclicos, anel fundido
- Ações farmacológicas
- Ações e usos químicos
- Indoles
- Alcalóides indol
- Compostos heterocíclicos, 3 anel
- Carbolinas
- Tadalafila
- Inibidores do transportador de sódio-glicose 2
- Empagliflozina
- dapagliflozina
Outros números de identificação do estudo
- METDDED-01
- PACTR202604903325533 (Identificador de registro: Pan African Clinical Trials Registry (PACTR))
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
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