The Prevalence of Prediabetes in Primary Care Medicine in Tunisia

NCT ID: NCT06825533

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-21
• Study Completion Date: 2025-08-21

Brief Summary

The study is national, observational and cross-sectional and aims to estimate the prevalence of prediabetes in primary care in Tunisia.

Detailed Description

TN-PREDIAB is a Tunisian, descriptive, non-interventional, multicenter and cross-sectional clinical study performed in primary care facilities, of both public and private sectors. The study will screen ambulatory patients for at least 4 months to estimate the prevalence of prediabetes among enrolled subjects.

The objectives of the study are:

• Primary objective: to estimate the overall prevalence of prediabetes among Tunisian population
• Secondary objective:
• Describe the clinical and epidemiological profile of prediabetic subjects
• Describe nutritional factors associated with prediabetes

A Scientific Committee validates the scientific writing, a Steering Committee supervises the clinical operations of the project.

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

Prediabetes

Study Design

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

Interventions

Fasting blood sugar level

Assess the level of Blood sugar level in fasting conditions at inclusion

Intervention Type: DIAGNOSTIC_TEST

Glycated hemoglobin

Assess the level of glycated hemoglobin at inclusion

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Ambulatory patient consulting in primary care in a public or private structure

Exclusion Criteria

• Known diabetes
• Concomitant medication that may influence blood sugar (corticosteroids, metformin, GLP1 analogues, SGLT2 inhibitor)
• Severe, acute or chronic comorbidity (end-stage renal failure, severe liver disease, heart failure)
• Severe anemia
• Pregnancy

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

Sponsors

Société Tunisienne de Médecine Générale et de Médecine de Famille

UNKNOWN

Sponsor Role: collaborator

Dacima Consulting

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed Haithem Ben Haj Salah, MD

Role: STUDY_CHAIR

Société Tunisienne de Médecine Générale et de Médecine de Famille

Habib Jerbi, MD

Role: STUDY_CHAIR

Société Tunisienne de Médecine Générale et de Médecine de Famille

Central Contacts

Mohamed Haithen Ben Haj Salah, MD

Role: CONTACT

haithembelhaj@yahoo.fr

+216 52 988 183

Habib Jerbi, MD

Role: CONTACT

drjerbi@yahoo.fr

+216 98 401 188

Other Identifiers

DAC-016-TUN-PREDIAB

Identifier Type: -

Identifier Source: org_study_id