Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT05577650
Brief Summary:
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.
Detailed Description:
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).
Study:
NCT05577650
Study Brief:
Protocol Section:
NCT05577650