TUN-CKDD: Prevalence of Chronic Kidney Disease in Tunisian Diabetics
Study Details
Study Description
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.
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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 Design
Outcome Measures
Primary Outcome Measures
- Prevalence of chronic kidney disease [At inclusion]
Frequency of diabetic subjects with chronic kidney disease
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 18 years old
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Diabetes Type 1 or Type 2
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Follow-up at the consultation for at least more than 3 months
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Informed consent of the patient
Exclusion Criteria:
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Kidney transplant
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Chronic dialysis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tunisian Society for Nephrology, Dialysis and Renal Transplantation | Tunis | Tunisia | 1000 |
Sponsors and Collaborators
- Dacima Consulting
- Tunisian Society for Nephrology, Dialysis and Renal Transplantation
Investigators
- Study Chair: Labidi Jannet, MD, Military Hospital of Tunis (Tunis, Tunisia)
- Principal Investigator: Amel Harzallah, MD, University Hospital of Charles Nicolle (Tunis, Tunisia)
- Principal Investigator: Awatef Azzabi, MD, University Hospital of Sahloul (Sousse, Tunisia)
- Principal Investigator: Badreddine Ben Kaab, MD, La Marsa Internal Security Forces Hospital (Tunis, Tunisia)
- Principal Investigator: Ikram Mami, MD, University Hospital of La Rabta (Tunis, Tunisia)
- Principal Investigator: Lamia Rais, MD, University Hospital of La Rabta (Tunis, Tunisia)
- Principal Investigator: Maissa Hadji Brahim, MD, University Hospital of Taher Sfar (Mahdia, Tunisia)
- Principal Investigator: Mouna Hammouda, MD, University Hospital of Fattouma Bourguiba (Monastir, Tunisia)
- Principal Investigator: Sahar Agrebi, MD, University Hospital of Charles Nicolle (Tunis, Tunisia)
- Principal Investigator: Seifeddine Azaiez, MD, Private Clinic (Ben Arous, Tunisia)
- Principal Investigator: Soumaya Chargui, MD, University Hospital of Charles Nicolle (Tunis, Tunisia)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- DAC-013-TUNCKDD