NCT06866002

Brief Summary

Populations in precarious situations or with low socio-economic status are at greater risk of diabetes and accelerated ageing. Depending on the population studied, the factors that may explain these health inequalities are not unequivocal and remain poorly understood. Northern France, which is particularly affected by socio-economic disparities, has one of the highest diabetes prevalence rates in mainland France. This is why the researchers wanted to study the clinical, biological, social and behavioral risk factors for the onset of diabetes and accelerated aging in a large population in northern France. A 2021 study aimed to characterize the population (a majority of whom (55%) suffer from precarious conditions) who came to the Institut Pasteur de Lille for their health check-up, in order to study risk factors to better explain these health inequalities. This research consisted of a descriptive observational cross-sectional study carried out on 2233 volunteers (main group) over 18 months, and a complementary analytical case-control study involving 216 participants (sub-group). At present, we are planning a 3-year follow-up of the cohort. Participants will be recontacted for a new health check-up at the Centre d'examen de Santé de l'Institut Pasteur de Lille. At the end of the health check-up, participants will be interviewed by PrévenDIAB study investigators to collect the same data as initially collected, with the exception of some data we deemed unnecessary.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
2,011

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Mar 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Mar 2025Dec 2027

First Submitted

Initial submission to the registry

March 4, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

March 5, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

2.7 years

First QC Date

March 4, 2025

Last Update Submit

March 4, 2025

Conditions

Keywords

Risk factorsPrecariousAccelerated aging(Pre) diabetes

Outcome Measures

Primary Outcomes (1)

  • fasting blood glucose and Hb1Ac

    Conversion rate of glycemic status (worsening, stable, improving) according to EPICES score. Prevalence of pre-diabetes/diabetes (T0 and T 3 years) according to EPICES score

    Day 0

Secondary Outcomes (4)

  • Prevalence ratio of (pre)diabetes calculated for clinical, biological and behavioral/environmental explanatory variables

    Day 0

  • Prevalence ratio of (pre) diabetes and accelerated aging according to the socio-economic status

    Day 0

  • Risk (odds Ratio) of (pre) diabetes and accelerated aging according to social, economic, cultural and professional status

    Until Day 90

  • Risk (odds Ratio) of (pre) diabetes and accelerated aging for assessed exposures

    Until Day 90

Study Arms (2)

Main Group

observational descriptive cohort

Other: Biological analysis, Physical examination and Questionnaires

Sub group

Case control study

Other: Physical examination and Questionnaires

Interventions

Biological analysis, Physical examination and questionnaires will be performed for all patients of the main group.

Main Group

In addition to exams for the main group, there will be 2 additional examinations (arterial stiffness) for the patients of the subgroup and others questionnaires.

Sub group

Eligibility Criteria

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

Populations in precarious situations or with low socio-economic status are at greater risk of developing diabetes and of accelerated ageing. Depending on the populations studied, the factors that may explain these health inequalities are not unequivocal and remain poorly understood. The Hauts-de-France region, which is particularly affected by socio-economic disparities, has one of the highest prevalence rates of diabetes in mainland France. That's why we want to study the clinical, biological, social and behavioral risk factors for diabetes onset and accelerated aging in a large population in northern France. Our study aims to characterize the population of consultants at the Centre d'Examens de Santé l'Institut Pasteur de Lille, the majority of whom (55%) suffer from precarious conditions, in order to study the risk factors that may better explain these health inequalities. This population will be monitored every 3 years to assess changes in the various parameters.

You may qualify if:

  • Participant in the PrévenDIAB study

You may not qualify if:

  • Refusal to participate in study
  • Scheduling impossible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Pasteur de Lille, Lille

Hauts de France, 59019, France

Location

MeSH Terms

Conditions

Diabetes MellitusPrediabetic StateGlucose Intolerance

Interventions

Restraint, PhysicalSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Philippe FROGUEL

    PhD PRECIDIAB

    STUDY CHAIR
  • Matthias VANDESQUILLE

    PhD PRECIDIAB

    STUDY DIRECTOR

Central Study Contacts

Frédéric BATTEUX, Pr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research prevention center manager

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 10, 2025

Study Start

March 5, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations