NCT06422598

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\'s (BADAS) affiliated healthcare centres is necessary. Objective: The study\'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: \"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.\"
  • 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 21, 2024

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

21 days

First QC Date

May 15, 2024

Last Update Submit

May 15, 2024

Conditions

Keywords

diabetesDiabetic kidney diseasePrevalencemanagement

Outcome Measures

Primary Outcomes (1)

  • Prevalence of diabetic kidney disease

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

    Day 1

Secondary Outcomes (3)

  • Risk Factors for DKD

    Day 1

  • Screening Practices

    Day 1

  • Management Approaches

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • All registered diabetic patients receiving care at affiliated healthcare centres of Bangladesh Diabetic Associations.

You may not qualify if:

  • Unwilling to participate in the study.
  • Presence of AKI or acute illness
  • Presence of Known kidney disease due to other cause.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Chapainawabganj Diabetes Center

Chapainawabganj, Bangladesh

RECRUITING

Cox's Bazar Diabetic Hospital

Cox’s Bāzār, Bangladesh

RECRUITING

Meherpur diabetes hospital

Meherpur, Bangladesh

NOT YET RECRUITING

Narayanganj Diabetic Hospital

Nārāyanganj, Bangladesh

RECRUITING

Diabetic Hospital Panchagarh

Panchagarh, Bangladesh

NOT YET RECRUITING

Pirojpur Diabetic Samiti

Pirojpur, Bangladesh

NOT YET RECRUITING

Rajbari Diabetes Center

Rājbāri, Bangladesh

RECRUITING

Sherpur Diabetic Hospital

Sherpur, Bangladesh

NOT YET RECRUITING

Related Publications (4)

  • 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.

  • 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.

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

  • 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.

MeSH Terms

Conditions

Diabetic NephropathiesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Wasim MM Haque, MBBS, FCPS

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wasim MM Haque, MBBS, FCPS

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 21, 2024

Study Start

May 11, 2024

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

May 21, 2024

Record last verified: 2024-05

Locations