Clinical trial NCT05577650: Prevalence of Chronic Kidney Disease in Tunisian Diabetics
Official title: Prevalence of Chronic Kidney Disease in Tunisian Diabetics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Diabetes Mellitus
Diabetes Type 2
Keywords: Chronic Kidney Disease
Diabetes
Survey
Lead sponsor: Dacima Consulting
Sponsor class: OTHER
Collaborators: name: Tunisian Society for Nephrology, Dialysis and Renal Transplantation
First posted: 2022-10-13
Enrollment: 10145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All diabetic subjects with at least 3 months of follow-up, before the inclusion date.

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).

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

Primary outcomes:
measure: Prevalence of chronic kidney disease
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Tunisian Society for Nephrology, Dialysis and Renal Transplantation
Study officials:
affiliation: Military Hospital of Tunis (Tunis, Tunisia)
name: Labidi Jannet, MD
role: STUDY_CHAIR
affiliation: University Hospital of Charles Nicolle (Tunis, Tunisia)
name: Amel Harzallah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Sahloul (Sousse, Tunisia)
name: Awatef Azzabi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: La Marsa Internal Security Forces Hospital (Tunis, Tunisia)
name: Badreddine Ben Kaab, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of La Rabta (Tunis, Tunisia)
name: Ikram Mami, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of La Rabta (Tunis, Tunisia)
name: Lamia Rais, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Taher Sfar (Mahdia, Tunisia)
name: Maissa Hadji Brahim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Fattouma Bourguiba (Monastir, Tunisia)
name: Mouna Hammouda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Charles Nicolle (Tunis, Tunisia)
name: Sahar Agrebi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Clinic (Ben Arous, Tunisia)
name: Seifeddine Azaiez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Charles Nicolle (Tunis, Tunisia)
name: Soumaya Chargui, MD
role: PRINCIPAL_INVESTIGATOR
References: