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NCT Number: NCT06825533

The Prevalence of Prediabetes in Primary Care Medicine in Tunisia

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

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fasting blood sugar level

Diagnostic Test

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

Glycated hemoglobin

Diagnostic Test

Assess the level of glycated hemoglobin at inclusion

Primary outcomes

  1. Prediabetes

    Time frame: At inclusion

    Percentage of prediabetic patients discovered at inclusion

Study contacts

Contact information is provided by the study sponsor or research team.

Habib Jerbi, MD

CONTACT

[email protected]

+216 98 401 188

Mohamed Haithen Ben Haj Salah, MD

CONTACT

[email protected]

+216 52 988 183

Sponsors and collaborators

Lead sponsor

Dacima Consulting

Other

Collaborators

  • Société Tunisienne de Médecine Générale et de Médecine de Famille

Registry information

Official study title

The Prevalence of Prediabetes in Primary Care Medicine in Tunisia. a National Descriptive Cross-Sectional Study

Acronym: TUN-PREDIAB

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 13, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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