Study of Diabetes' Risk Factors and Accelerated Aging According to Socio-economic Status in a Population from the North of France - 3-year Follow-up (PrévenDIAB 2)

March 4, 2025 updated by: Coralie BERTHIER, Institut Pasteur de Lille

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objective : To measure changes in fasting glycemic control after 3 years in PrevenDIAB-1 study participants according to socioeconomic status

Primary efficacy endpoint : fasting plasma 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

Secondary objectivesspecific to the main group :

  • Observe the evolution of anthropometric factors such as BMI (weight), waist circumference and various measures of body composition, and determine their role in the evolution of glycemia.
  • Observe the evolution of clinical, biological, metabolomic, behavioral and environmental factors, and determine their role in the evolution of glycemia.
  • Measure the impact of PrevenDIAB-1 (+/- prevention intervention) on changes in behaviour and health perception according to socio-economic status (has the completion of a health check-up enabled people to resume a course of care and/or raise awareness/engage in prevention?)
  • Gather information on subjects' possible participation in preventive actions, define them (type, duration, indication, etc.) and assess their potential impact on risk factors.
  • Propose a personalized care pathway for different risk profiles (roadmap defined for people with diabetes or morbid obesity, for example), create a city-hospital link and follow up with subjects by telephone at 6 months to obtain their feedback/opinions on the management of their pathology.

Secondary Objectives specific to the sub-group:

  • Measure changes in the following subgroup parameters:

    • physical activity
    • sleep
    • alcohol consumption
    • frailty
    • arterial stiffness
    • cognitive status
  • Determine the link with pre-diabetes and diabetes.

  • Obtain qualitative data by setting up focus groups on the co-creation of a "space of trust" promoting health empowerment.

    • This work will be carried out by a "health and human sciences" post-doc in 2025.

Study Type

Observational

Enrollment (Estimated)

2011

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Hauts de France, France, 59019

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • Participant in the PrévenDIAB study

Exclusion Criteria:

  • Subject participating in another clinical study or in a period of exclusion from another study and incompatible with PrévenDIAB-2 follow-up
  • Refusal to participate in study
  • Scheduling impossible

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sub group
Case control study
Other: Physical examination and Questionnaires
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.
Main Group
observational descriptive cohort
Other: Biological analysis, Physical examination and Questionnaires
Biological analysis, Physical examination and questionnaires will be performed for all patients of the main group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fasting blood glucose and Hb1Ac
Time Frame: Day 0
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence ratio of (pre)diabetes calculated for clinical, biological and behavioral/environmental explanatory variables
Time Frame: Day 0
In %
Day 0
Prevalence ratio of (pre) diabetes and accelerated aging according to the socio-economic status
Time Frame: Day 0
In %
Day 0
Risk (odds Ratio) of (pre) diabetes and accelerated aging according to social, economic, cultural and professional status
Time Frame: Until Day 90
Without units
Until Day 90
Risk (odds Ratio) of (pre) diabetes and accelerated aging for assessed exposures
Time Frame: Until Day 90
Without units
Until Day 90

Collaborators and Investigators

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

Sponsor

Institut Pasteur de Lille

Investigators

  • Study Chair: Philippe FROGUEL, PhD PRECIDIAB
  • Study Director: Matthias VANDESQUILLE, PhD PRECIDIAB

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 (Estimated)

March 5, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A02836-41

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

product manufactured in and exported from the U.S.

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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