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OpenTrials
Completed

NCT Number: NCT05577650

Prevalence of Chronic Kidney Disease in Tunisian Diabetics

In Tunisia, diabetes is a serious public health problem, its prevalence reaches 22.9% of people aged 18 and over and is likely to affect a quarter of the population by 2045. Diabetic kidney disease is the most common and severe complication of diabetes. It is both a major cause of end-stage renal disease and a risk factor for mortality and cardiovascular morbidity, thus becoming an additional public health concern. Early diagnosis of diabetic kidney disease makes it possible to manage patients more effectively and in a multidisciplinary way, to delay its progression to chronic renal failure.

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Key information

About this study

In Tunisia, little data exist concerning the epidemiology of chronic kidney disease in diabetics. It is then relevant to assess the incidence of chronic kidney disease among the Tunisian diabetic population.

The study is an observational, multicentric, cross-sectional, and national project. The study will be carried out for one month at medical departments and ambulatory clinics of general physicians, family medicine specialists, endocrinologists, specialists in nutrition and metabolic diseases, nephrologists, internal medicine physicians, cardiologists, or any healthcare providers in charge of diabetic patients.

A Steering Committee helps investigators to monitor their patient inclusions, performs audit trails and prepares the statistical analysis plan for the study. Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years old
  • Diabetes Type 1 or Type 2
  • Follow-up at the consultation for at least more than 3 months
  • Informed consent of the patient

Exclusion criteria

  • Kidney transplant
  • Chronic dialysis

Treatment and study plan

Primary outcomes

  1. Prevalence of chronic kidney disease

    Time frame: At inclusion

    Frequency of diabetic subjects with chronic kidney disease

Sponsors and collaborators

Lead sponsor

Dacima Consulting

Other

Collaborators

  • Tunisian Society for Nephrology, Dialysis and Renal Transplantation

Registry information

Acronym: TUN-CKDD

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2022
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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