## Protocol Section
### Identification Module
**NCT ID:** NCT06422598

**Acronym:** BADAS

**Brief Title:** Prevalence and Management Practice of Diabetic Kidney Disease at BADAS Affiliated Healthcare Centres in Bangladesh

**Official Title:** Prevalence and Management Practice of Diabetic Kidney Disease at BADAS Affiliated Healthcare Centres in Bangladesh - An Exploratory Cross-Sectional Study

#### Organization Study ID Info
**ID:** BADAS-ERC/EC/24/23
#### Organization
**Class:** OTHER
**Full Name:** Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
#### Secondary ID Infos
**Domain:** The Diabetic Association of Bangladesh (BADAS)
**ID:** BADAS-ERC/EC/24/23
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-11

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Ibrahim Medical College

#### Lead Sponsor

**Class:** OTHER

**Name:** Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders

#### Responsible Party

**Investigator Affiliation:** Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders

**Investigator Full Name:** Wasim Md Mohosin Ul Haque

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Background: Diabetes is a growing public health concern in Bangladesh, with millions affected. Diabetic Kidney Disease (DKD) is a severe complication of diabetes, affecting approximately 21.3% of the diabetic population. To address this issue, a comprehensive assessment of DKD within the Bangladesh Diabetic Association\&#39;s (BADAS) affiliated healthcare centres is necessary.

Objective: The study\&#39;s general objective is to determine the prevalence of DKD and evaluate its management at BADAS-affiliated healthcare centers. Specific objectives include assessing risk factors, screening practices, disease staging, management approaches, patient education, and providing evidence-based recommendations.

Methodology:

* Study Design: Cross-sectional
* Study Population: All diabetic patients at BADAS-affiliated centers
* Exclusion Criteria: Patients unwilling to participate or with kidney disease from other causes and with acute illness
* Sample Size: \&#34;Forty patients will be selected from each center, resulting in a total sample size of 320 patients across eight centers, with one center randomly selected from each of the eight divisions in Bangladesh.\&#34;
* Data Collection: Demographics, comorbidities, kidney function, blood pressure, HbA1c levels, medication records, treatment guideline adherence
* Data Analysis: prevalence of diabetic kidney disease, factors affecting management, and potential barriers
* Ethical Considerations: Ensure patient data privacy, obtain approvals, and informed consent Implications: The study aims to provide insights into the current state of magnitude (prevalence) of DKD, its management, highlighting areas for improvement in patient care, guideline adherence, and ultimately enhancing the well-being of diabetic patients in Bangladesh.

**Detailed Description:** 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\&#39; 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 (\&gt;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): \&lt;60ml/minute/1.73m2. for more than 3 months Duration of Diabetes: DKD is typically associated with a long duration of diabetes (\&gt;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., \&lt;130/80 mm Hg), glycaemic control (e.g., HbA1c \&lt;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.

### Conditions Module

**Conditions:**

- Diabetic Kidney Disease

**Keywords:**

- diabetes

- Diabetic kidney disease

- Prevalence

- management

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 320

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Calculate the prevalence of DKD among diabetic patients visiting BADAS-affiliated healthcare centers using clinical and laboratory assessments.

**Measure:** Prevalence of diabetic kidney disease

**Time Frame:** Day 1

#### Secondary Outcomes

**Description:** Identify and analyze demographic and clinical factors associated with the development of DKD in the study population.

**Measure:** Risk Factors for DKD

**Time Frame:** Day 1

**Description:** 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.

**Measure:** Screening Practices

**Time Frame:** Day 1

**Description:** Investigate the treatment modalities, including pharmacological interventions, lifestyle modifications, and patient education, used to manage DKD in the healthcare centers.

**Measure:** Management Approaches

**Time Frame:** Day 1

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** 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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** wmmhaque@live.com

**Name:** Wasim MM Haque, MBBS, FCPS

**Phone:** +8801915472750

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chapainawabganj

**Contacts:**

***Contact 1:***

- **Name:** Khokon

- **Role:** CONTACT

**Country:** Bangladesh

**Facility:** Chapainawabganj Diabetes Center

**Status:** RECRUITING

**Location 2:**

**City:** Cox's Bazar

**Contacts:**

***Contact 1:***

- **Name:** Bivision

- **Role:** CONTACT

**Country:** Bangladesh

**Facility:** Cox's Bazar Diabetic Hospital

**Status:** RECRUITING

**Location 3:**

**City:** Meherpur

**Contacts:**

***Contact 1:***

- **Name:** Jiptaho

- **Role:** CONTACT

**Country:** Bangladesh

**Facility:** Meherpur diabetes hospital

**Status:** NOT_YET_RECRUITING

**Location 4:**

**City:** Narayanganj

**Contacts:**

***Contact 1:***

- **Name:** Rafiq

- **Role:** CONTACT

**Country:** Bangladesh

**Facility:** Narayanganj Diabetic Hospital

**Status:** RECRUITING

**Location 5:**

**City:** Panchagarh

**Contacts:**

***Contact 1:***

- **Name:** Rowshan

- **Role:** CONTACT

**Country:** Bangladesh

**Facility:** Diabetic Hospital Panchagarh

**Status:** NOT_YET_RECRUITING

**Location 6:**

**City:** Pirojpur

**Contacts:**

***Contact 1:***

- **Name:** Uzzal

- **Role:** CONTACT

**Country:** Bangladesh

**Facility:** Pirojpur Diabetic Samiti

**Status:** NOT_YET_RECRUITING

**Location 7:**

**City:** Rajbari

**Contacts:**

***Contact 1:***

- **Name:** Shahid

- **Role:** CONTACT

**Country:** Bangladesh

**Facility:** Rajbari Diabetes Center

**Status:** RECRUITING

**Location 8:**

**City:** Sherpur

**Contacts:**

***Contact 1:***

- **Name:** Ashish

- **Role:** CONTACT

**Country:** Bangladesh

**Facility:** Sherpur Diabetic Hospital

**Status:** NOT_YET_RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders

**Name:** Wasim MM Haque, MBBS, FCPS

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Jeffrie Seley J, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 15. Management of Diabetes in Pregnancy: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S254-S266. doi: 10.2337/dc23-S015.

**PMID:** 36507645

**Citation:** Islam SMS, Salehin M, Zaman SB, Tansi T, Gupta RD, Barua L, Banik PC, Uddin R. Factors Associated with Chronic Kidney Disease in Patients with Type 2 Diabetes in Bangladesh. Int J Environ Res Public Health. 2021 Nov 23;18(23):12277. doi: 10.3390/ijerph182312277.

**PMID:** 34886001

**Citation:** McGrath K, Edi R. Diabetic Kidney Disease: Diagnosis, Treatment, and Prevention. Am Fam Physician. 2019 Jun 15;99(12):751-759.

**PMID:** 31194487

**Citation:** Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, Stein C, Basit A, Chan JCN, Mbanya JC, Pavkov ME, Ramachandaran A, Wild SH, James S, Herman WH, Zhang P, Bommer C, Kuo S, Boyko EJ, Magliano DJ. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022 Jan;183:109119. doi: 10.1016/j.diabres.2021.109119. Epub 2021 Dec 6. Erratum In: Diabetes Res Clin Pract. 2023 Oct;204:110945.

**PMID:** 34879977

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000048909

- Term: Diabetes Complications

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: HIGH

- As Found: Kidney Disease

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M7123

- Name: Diabetic Nephropathies

- Relevance: HIGH

- As Found: Diabetic Kidney Disease

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26004

- Name: Diabetes Complications

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007674

- Term: Kidney Diseases

- ID: D000003928

- Term: Diabetic Nephropathies

### Misc Info Module

- Version Holder: 2024-05-31
