Prevalence of Chronic Kidney Disease in Tunisian Diabetics

NCT ID: NCT05577650

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10145 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2023-02-12

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).

Conditions

Chronic Kidney Diseases; Diabetes Mellitus; Diabetes Type 2

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tunisian Society for Nephrology, Dialysis and Renal Transplantation

UNKNOWN

Sponsor Role: collaborator

Dacima Consulting

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Labidi Jannet, MD

Role: STUDY_CHAIR

Military Hospital of Tunis (Tunis, Tunisia)

Amel Harzallah, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Charles Nicolle (Tunis, Tunisia)

Awatef Azzabi, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Sahloul (Sousse, Tunisia)

Badreddine Ben Kaab, MD

Role: PRINCIPAL_INVESTIGATOR

La Marsa Internal Security Forces Hospital (Tunis, Tunisia)

Ikram Mami, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of La Rabta (Tunis, Tunisia)

Lamia Rais, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of La Rabta (Tunis, Tunisia)

Maissa Hadji Brahim, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Taher Sfar (Mahdia, Tunisia)

Mouna Hammouda, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Fattouma Bourguiba (Monastir, Tunisia)

Sahar Agrebi, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Charles Nicolle (Tunis, Tunisia)

Seifeddine Azaiez, MD

Role: PRINCIPAL_INVESTIGATOR

Private Clinic (Ben Arous, Tunisia)

Soumaya Chargui, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Charles Nicolle (Tunis, Tunisia)

Locations

Tunisian Society for Nephrology, Dialysis and Renal Transplantation

Tunis, , Tunisia

Countries

Tunisia

Related Links

https://www.facebook.com/STNDTR/

FB page of STNDTR

Other Identifiers

DAC-013-TUNCKDD

Identifier Type: -

Identifier Source: org_study_id