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BADASPrevalence and Management Practice of Diabetic Kidney Disease at BADAS Affiliated Healthcare Centres in Bangladesh - An Exploratory Cross-Sectional Study

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Qué se está recopilando

Colección de datos

Recopilados en un punto de tiempo - Transversal
Quiénes están siendo reclutados

Enfermedades Urogenitales+6

+ Enfermedades del Sistema Endocrino

+ Nefropatías Diabéticas

A partir de 18 años
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Cómo está diseñado el estudio

Solo Casos

Examinando las características de las personas con una enfermedad para identificar factores genéticos o ambientales que contribuyen a la condición.
Observacional
Inicio del estudio: mayo de 2024
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Resumen

Patrocinador PrincipalBangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
Contacto del EstudioWasim MM Haque, MBBS, FCPS
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 11 de mayo de 2024

Fecha en la que se inscribió al primer participante.

Background: Diabetes mellitus represents a significant public health challenge globally, and Bangladesh is no exception to this growing epidemic. According to the International Diabetes Federation (IDF), about 13.1 million people in Bangladesh have diabetes, and this number is expected to increase to 22.3 million by 2045(Sun et al., 2022). One of the most serious complications of diabetes is Diabetic Kidney Disease (DKD), which can lead to chronic kidney disease and end-stage renal disease (ESRD). DKD not only imposes a heavy burden on the healthcare system but also affects the economic and social well-being of the patients and their families. The prevalence of kidney disease among the diabetic population of Bangladesh is estimated to be around 21.3%. This number is based on a single center study conducted at the Bangladesh Institute of Health Sciences (BIHS) hospital in Dhaka, Bangladesh(Islam et al., 2021). This high prevalence highlights the need for a comprehensive evaluation of DKD within the centers affiliated with the Bangladesh diabetic association (BADAS), which is the largest non-governmental organization providing diabetes care and research in the country. The Bangladesh Diabetic Association (BADAS), with its extensive network of diabetes care centers and healthcare professionals, has long been at the forefront of addressing diabetes-related health concerns in the country. As a nation-wide institution dedicated to diabetes care, BADAS plays a pivotal role in delivering healthcare services and shaping the well-being of diabetic patients in Bangladesh. A comprehensive understanding of DKD prevalence and management status within BADAS centers is essential to enhance the quality of care for diabetic patients. Identifying areas for improvement is the first step towards effecting positive change. Our ultimate plan is to implement a nationwide DKD prevention program through affiliated diabetic centers. To achieve this, a comprehensive assessment of the current situation is an imperative foundation for program design, planning, and execution. The study will provide a rich dataset upon which evidence-based recommendations for preventing and managing DKD within BADAS-affiliated centers can be developed. These recommendations are essential for improving patient outcomes and ensuring the success of the future prevention program. In conclusion, the proposed study is a crucial undertaking aimed at addressing the pressing issue of DKD within the context of BADAS-affiliated healthcare centers. It serves as the first step towards the larger goal of implementing a nationwide DKD prevention program, with the potential to positively impact the health and well-being of diabetic patients across Bangladesh. Objective: General Objective: To determine the prevalence of diabetic kidney disease and assess the management status of diabetic kidney disease in patients attending affiliated healthcare centers of the Bangladesh Diabetic Associations. Specific Objectives: Determine the Prevalence of Diabetic Kidney Disease: Calculate the prevalence of DKD among diabetic patients visiting BADAS-affiliated healthcare centers using clinical and laboratory assessments. Assess Risk Factors for DKD: Identify and analyze demographic and clinical factors associated with the development of DKD in the study population. Evaluate Screening Practices: Evaluate the extent to which BADAS-affiliated healthcare centers conduct regular screening of registered diabetic patients for DKD and assess the effectiveness of current screening protocols. Characterize Disease Staging: Determine the stages of DKD among patients diagnosed with the condition and assess the proportion of patients with various stages of renal impairment. Analyze Management Approaches: Investigate the treatment modalities, including pharmacological interventions, lifestyle modifications, and patient education, used to manage DKD in the healthcare centers. Assess Healthcare Professional Awareness: Evaluate the awareness and knowledge of healthcare professionals working in BADAS-affiliated centres regarding DKD prevention, diagnosis, and management. Assess the infrastructural support of BADAS-affiliated centres regarding DKD prevention, diagnosis, and management. Examine Patient Education and Engagement: Assess the level of patient education and engagement in DKD management programs, including lifestyle modification guidance and adherence to treatment plans. Provide Recommendations: Based on the study findings, generate evidence-based recommendations for improving the prevention, early detection, and management of DKD in BADAS-affiliated healthcare centers to enhance the quality of care for diabetic patients. Material and Methodology: Study Design: Cross-sectional study design. Study Population: All registered diabetic patients receiving care at affiliated healthcare centres of Bangladesh Diabetic Associations. Exclusion criteria: Unwilling to participate in the study. Presence of AKI or acute illness Presence of Known kidney disease due to other cause. Sampling method: Multi-stage sampling. Sample size calculation: The formula to calculate the sample size: Where: n = required sample size Z = Z-score corresponding to the desired confidence level (e.g., 1.96 for a 95% confidence level) p = expected prevalence (in decimal form) E = margin of error (in decimal form) Expected prevalence of DKD to be 21.3% (0.213 in decimal form) Confidence level 95% Margin of error of 5% (0.05 in decimal form) Using these values, the sample size calculation would look like this: = 292 However, we will select forty patients from each centre, resulting in a total sample size of 320 patients across eight centres, with one centre will be randomly selected from each of the eight divisions in Bangladesh. Data Collection: Gather patient data, including demographics, comorbidities, kidney function (eGFR, UACR), blood pressure measurements, and HbA1c levels. Review medication records to determine the use of anti-proteinuric medications (e.g., ACE inhibitors, angiotensin receptor blockers, SGLT2i, nonsteroidal mineralocorticoids receptor antagonists and GLP analogues). Assess adherence to recommended treatment guidelines for diabetic kidney disease management. Collect data on healthcare professionals\' awareness and knowledge of DKD prevention, diagnosis, and management. Gather data on the infrastructure available in BADAS-affiliated centres for DKD prevention, diagnosis, and management. Screening for the presence of DKD The diagnostic criteria for diabetic kidney disease (DKD)(McGrath and Edi, 2019, ElSayed et al., 2022): DKD is usually a clinical diagnosis in a patient with long-standing diabetes (\>10 years) with albuminuria and/or reduced eGFR in the absence of signs or symptoms of other primary causes of kidney damage. Albuminuria: Increased urinary albumin excretion is defined as ≥30 mg/g. (2 out of 3 in 3 to 6 months). Reduced estimated Glomerular Filtration Rate (eGFR): \<60ml/minute/1.73m2. for more than 3 months Duration of Diabetes: DKD is typically associated with a long duration of diabetes (\>10 years' duration of type 1 diabetes; may be present at diagnosis in type 2 diabetes). Presence of Retinopathy: DKD is typically associated with retinopathy however the absence of retinopathy does not exclude DKD in type 2 diabetes. Data Analysis: Evaluate the proportion of patients achieving target blood pressure control (e.g., \<130/80 mm Hg), glycaemic control (e.g., HbA1c \<7%), and receiving appropriate anti-proteinuric medications. Examine factors associated with successful management, including age, gender, duration of diabetes, and comorbidities. Identify potential barriers to achieving optimal management. Ethical Considerations: Ensure patient data privacy and confidentiality. Obtain necessary approvals and informed consent for data access and analysis. Implications: Provide insights into the current magnitude and state of diabetic kidney disease management, specifically focusing on blood pressure and glycaemic control and the utilization of anti-proteinuric medications among diabetic patients. Highlight areas for improvement in patient care and guideline adherence to enhance diabetic kidney disease management.

Título OficialPrevalence and Management Practice of Diabetic Kidney Disease at BADAS Affiliated Healthcare Centres in Bangladesh - An Exploratory Cross-Sectional Study
NCT06422598
Patrocinador PrincipalBangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
Contacto del EstudioWasim MM Haque, MBBS, FCPS
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 320 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Solo Casos

Estos estudios se centran únicamente en personas con una enfermedad específica. Se analizan patrones, frecuentemente genéticos o ambientales, para identificar posibles factores relacionados con la condición.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades UrogenitalesEnfermedades del Sistema EndocrinoNefropatías DiabéticasDiabetes MellitusEnfermedades Urogenitales Femeninas y Complicaciones del EmbarazoEnfermedades RenalesEnfermedades metabólicasEnfermedades Nutricionales y MetabólicasEnfermedades Urológicas

Criterios

Inclusion Criteria: • All registered diabetic patients receiving care at affiliated healthcare centres of Bangladesh Diabetic Associations. Exclusion Criteria: * Unwilling to participate in the study. * Presence of AKI or acute illness * Presence of Known kidney disease due to other cause. * Pregnancy

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Objetivos del Estudio

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 8 ubicaciones

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Chapainawabganj Diabetes Center

Chapainawabganj, BangladeshAbrir Chapainawabganj Diabetes Center en Google Maps
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Cox's Bazar Diabetic Hospital

Cox’s Bāzār, Bangladesh
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Narayanganj Diabetic Hospital

Nārāyanganj, Bangladesh
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Rajbari Diabetes Center

Rājbāri, Bangladesh
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8 Centros de Estudio