NCT05717491

Brief Summary

Populations in precarious situations or with low socio-economic status have an increased risk of diabetes and accelerated aging. According to the population studied, the elements that can explain these health inequalities are not unequivocal and remain poorly known. The north of France, particularly affected by socio-economic disparities, has a prevalence of diabetes among the highest in metropolitan France. This is why investigators want to study the clinical, biological, social and behavioural risk factors of the entry into diabetes and accelerated aging among a large population in the North of France. This study aims to characterize the population (among which a majority (55%) suffers from precarious conditions) who come to carry out their health examination at the Pasteur Institute in Lille in order to study the risk factors to better explain these health inequalities. This research consists of a main descriptive observational, cross-sectional study carried out on 2233 volunteers (main group) over 18 months, and a complementary analytical case-control study that will be offered to 216 participants (sub-group).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,014

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 14, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

December 14, 2021

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

2.3 years

First QC Date

December 14, 2021

Last Update Submit

April 19, 2024

Conditions

Keywords

(Pre) diabetesRisk factorsPrecariousAccelerated aging

Outcome Measures

Primary Outcomes (1)

  • Fasting glucose value according to the level of precariousness

    Glycemia in g/L Level of precariousness given by EPICES score

    Day 0

Secondary Outcomes (5)

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

    Day 0

  • Assessment of the level of accelerated ageing (DNAmPhenoAge)

    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

Cross-sectional study

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 (bone densitometry and 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 a low socioeconomic level have an increased risk of entering diabetes and aging accelerated. Depending on the populations studied, the elements that could explain these health inequalities are not unequivocal and are still badly known. The Hauts-de-France region, particularly affected by disparities socio-economic, has one of the most prevalent diabetes high in the metropolis. This is why it's important to study the factors clinical, biological, social and behavioral risks of entry in diabetes and accelerated aging in a large population of North of France. This study aims to characterize the population of the Centre's consultants of Health Examinations at the Institut Pasteur de Lille, of which a majority (55%) suffers from precarious conditions, in order to study the risk factors to better explain these health inequalities.

You may qualify if:

  • Adult, male or female
  • Consultant for the health prevention examination at the Examination Centre of Health of the Institut Pasteur of Lille
  • Available to follow the constraints generated by the study
  • Signature of the informed consent
  • Status of insured person in France

You may not qualify if:

  • Adult deprived of liberty or under judicial protection
  • Impediment to give the free and informed consent (understanding, persons under guardianship/curators, etc.)
  • Incompatible scheduling
  • Other reason (state of health or concomitant treatments,...) considered by the principal investigator or a qualified co-investigator not compatible with the proper conduct of the clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Pasteur de Lille

Lille, Hauts-de-France, 59019, France

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

DNA methylation

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 Dr FROGUEL, PhD

    PRECIDIAB

    STUDY CHAIR
  • Matthias Mr VANDESQUILLE, PhD

    PRECIDIAB

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical director of CPSL

Study Record Dates

First Submitted

December 14, 2021

First Posted

February 8, 2023

Study Start

December 14, 2021

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations