Prevalence of Chronic Kidney Disease in Tunisian Diabetics (TUN-CKDD)

May 9, 2023 updated by: Dacima Consulting
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

10145

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Tunis, Tunisia, 1000
        • Tunisian Society for Nephrology, Dialysis and Renal Transplantation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All diabetic subjects with at least 3 months of follow-up, before the inclusion date.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of chronic kidney disease
Time Frame: At inclusion
Frequency of diabetic subjects with chronic kidney disease
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dacima Consulting

Collaborators

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2023

Primary Completion (Actual)

February 12, 2023

Study Completion (Actual)

February 12, 2023

Study Registration Dates

First Submitted

October 10, 2022

First Submitted That Met QC Criteria

October 10, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAC-013-TUNCKDD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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