Diastolic Dysfunction and Pulmonary Hypertension in T2DM With Microalbuminuria
Diastolic Dysfunction and Pulmonary Hypertension in Type 2 Diabetes Mellitus With Microalbuminuria in Upper Egypt
This is a cross-sectional observational study comparing echocardiographic markers of left ventricular diastolic function and pulmonary artery systolic pressure among healthy controls and patients with type 2 diabetes mellitus, stratified by albuminuria status (normal, microalbuminuria, macroalbuminuria) according to KDIGO 2024 criteria. The study is being conducted in Upper Egypt and aims to characterize the relationship between the albuminuria spectrum and cardiac diastolic/pulmonary vascular involvement in type 2 diabetes, alongside glycemic control and diabetes duration.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Type 2 diabetes mellitus (T2DM) is associated with subclinical cardiac abnormalities that often precede overt heart failure. Diabetic cardiomyopathy is characterized early by impaired left ventricular relaxation and increased filling pressures, detectable echocardiographically as left ventricular diastolic dysfunction (LVDD), frequently before any drop in ejection fraction. Pulmonary hypertension (PH) is increasingly recognized as a comorbid finding in diabetic populations, potentially arising secondary to diastolic dysfunction, microvascular disease, or both.
Albuminuria is a graded marker of generalized microvascular endothelial dysfunction in diabetes, classified by KDIGO 2024 criteria into normal-to-mildly-increased, moderately increased (microalbuminuria), and severely increased (macroalbuminuria) categories, corresponding to progressive cardiovascular and renal risk. While microalbuminuria in isolation has been linked to adverse cardiopulmonary outcomes, the relationship between the full albuminuria spectrum and echocardiographic indices of diastolic dysfunction and PH has not been well characterized, particularly against a non-diabetic control benchmark, in an Upper Egyptian population.
This protocol compares standard transthoracic echocardiographic markers of diastolic dysfunction and PH, alongside glycemic control (HbA1c) and diabetes duration, across four groups: healthy controls and T2DM patients with normal albuminuria, microalbuminuria, and macroalbuminuria.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: shady Elsdfy, MD
- Número de teléfono: 01028792280
- Correo electrónico: elsdfyshady@gmail.com
Ubicaciones de estudio
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Asyut Governorate
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Asyut, Asyut Governorate, Egipto, 71515
- Assiut University Hospital
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Contacto:
- Shady A Omar, MBBCh
- Número de teléfono: 01028792280
- Correo electrónico: elsdfyshady@gmail.com
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Contacto:
- Mohamed Faisal Adawy, Lecturer
- Número de teléfono: +20 10 1244126
- Correo electrónico: DR-m.faisal85m@aun.edu.eg
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients recruited from Cardiology and Internal Medicine/Endocrinology outpatient clinics and inpatient wards at Assiut University Hospital, Upper Egypt, along with age- and sex-matched non-diabetic controls.
Descripción
Inclusion Criteria:
- Four groups will be recruited: (1) healthy, non-diabetic controls, age- and sex-matched to the diabetic groups; (2) T2DM with normal albuminuria (KDIGO A1, urine ACR <30 mg/g); (3) T2DM with microalbuminuria (KDIGO A2, ACR 30-300 mg/g); (4) T2DM with macroalbuminuria (KDIGO A3, ACR >300 mg/g). Diabetic groups: adult patients (≥18 years) with an established diagnosis of type 2 diabetes mellitus. Control group: adults (≥18 years) without diabetes (confirmed by fasting glucose/HbA1c), age- and sex-matched to the diabetic groups. All groups: willingness and ability to provide informed consent.
Exclusion Criteria:
Type 1 diabetes or secondary forms of diabetes; known primary valvular heart disease (moderate or greater); prior myocardial infarction or established coronary artery disease with regional wall motion abnormality; reduced ejection fraction (EF < 50%) on screening echocardiography; chronic kidney disease stage ≥4 or dialysis dependence; known chronic lung disease or other secondary causes of pulmonary hypertension unrelated to left heart disease; atrial fibrillation or other rhythm disturbance precluding reliable diastolic assessment; pregnancy. Note: systemic hypertension is not an exclusion criterion, given its high prevalence as a diabetes comorbidity; it will instead be recorded and analyzed as a covariate.
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Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: CROSS_SECTIONAL
Cohortes e Intervenciones
Grupo / Cohorte |
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Group 1
Group/Cohort Label: Healthy Controls Description: Non-diabetic adults, age- and sex-matched to the diabetic groups, confirmed by fasting glucose/HbA1c. |
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Group 2
Group/Cohort Label: T2DM with Normoalbuminuria Description: Adult patients with type 2 diabetes mellitus and normal urinary albumin-to-creatinine ratio (KDIGO A1, ACR <30 mg/g). |
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Group 3
Group/Cohort Label: T2DM with Microalbuminuria Description: Adult patients with type 2 diabetes mellitus and moderately increased albuminuria (KDIGO A2, ACR 30-300 mg/g). |
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Group 4
Group/Cohort Label: T2DM with Macroalbuminuria Description: Adult patients with type 2 diabetes mellitus and severely increased albuminuria (KDIGO A3, ACR >300 mg/g). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Diastolic Dysfunction and Pulmonary Hypertension Across Albuminuria Groups
Periodo de tiempo: At time of enrollment (single time-point cross-sectional assessment)
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Title: Prevalence of left ventricular diastolic dysfunction (LVDD) Description: Percentage of participants with LVDD, defined by the 2016 ASE/EACVI algorithm using transthoracic Doppler echocardiography, compared between the control, T2DM-normoalbuminuria, T2DM-microalbuminuria and T2DM-macroalbuminuria groups. Time Frame: At enrollment (single study visit) Outcome 2 Title: Grade of LVDD Description: Percentage of participants in each LVDD grade (grade I, II, III), graded according to the 2016 ASE/EACVI guidelines using transthoracic Doppler echocardiography, compared between the four groups. Time Frame: At enrollment (single study visit) Outcome 3 Title: Frequency of pulmonary hypertension (PH) Description: Percentage of participants with echocardiographic pulmonary hypertension, defined per 2022 ESC/ERS criteria using transthoracic Doppler echocardiography, compared between the four groups. Time Frame: At enrollment (single study visit). |
At time of enrollment (single time-point cross-sectional assessment)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Correlation of Diastolic Dysfunction and PASP with Glycemic Control and Diabetes Duration
Periodo de tiempo: At time of enrollment (single time-point cross-sectional assessment)
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Correlation of diastolic dysfunction parameters and pulmonary artery systolic pressure (PASP) with HbA1c and diabetes duration within the diabetic subgroups, using Pearson or Spearman correlation as appropriate. Multivariable regression will be used to adjust for hypertension and other covariates influencing these associations across all four groups. |
At time of enrollment (single time-point cross-sectional assessment)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: shady A Elsdfy, MD, Assiut University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 04-2026-100520
- SCCREIRB-MEDICIASSIUT-GU-001-2 (Otro identificador: Assiut Faculty of Medicine Institutional Review Board)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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