NCT06825533

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 21, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

February 9, 2025

Last Update Submit

February 23, 2025

Conditions

Prediabetes

Keywords

PrediabetesSTMGFSurvey

Outcome Measures

Primary Outcomes (1)

  • Prediabetes

    Percentage of prediabetic patients discovered at inclusion

    At inclusion

Interventions

Fasting blood sugar levelDIAGNOSTIC_TEST

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

Glycated hemoglobinDIAGNOSTIC_TEST

Assess the level of glycated hemoglobin at inclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ambulatory patient consulting in primary care in a public or private structure, without patent diabetes

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Mohamed Haithem Ben Haj Salah, MD

    Société Tunisienne de Médecine Générale et de Médecine de Famille

    STUDY CHAIR

  • Habib Jerbi, MD

    Société Tunisienne de Médecine Générale et de Médecine de Famille

    STUDY CHAIR

Central Study Contacts

Mohamed Haithen Ben Haj Salah, MD

CONTACT

+216 52 988 183haithembelhaj@yahoo.fr

Habib Jerbi, MD

CONTACT

+216 98 401 188drjerbi@yahoo.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2025

First Posted

February 13, 2025

Study Start

April 21, 2025

Primary Completion

August 21, 2025

Study Completion

August 21, 2025

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share