Study of Diabetes' Risk Factors and Accelerated Aging According to Socio-economic Status in a Population From the North of France

NCT ID: NCT05717491

Last Updated: 2024-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2014 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-14

Study Completion Date

2024-03-31

Brief Summary

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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).

Detailed Description

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Primary Objective : Assessment of Prevalence of Prediabetes and Diabetes by Socio-Economic Status

Primary efficacy endpoint : Fasting glucose value based on EPICES score :

Glycemia:

* Normal: fasting glucose ≤ 1g/l
* Prediabetes: fasting glucose \>1 g/l and ≤1.25 g/l
* Diabetes: fasting glucose \>1.25 g/l

EPICES score: quintiles of score distribution (Q1 to Q5)

Secondary Objectives specific to the main group:

* Characterize the population and analyze the risk factors (clinical, biological, socio-economic and behavioural) of diabetes and prediabetes in this population.
* Study the level of biological ageing and factors associated with accelerated ageing.
* Estimate the risk of (pre)diabetes and accelerated aging based on socio-economic profile.

Secondary Objectives specific to the sub-group:

* Assess the impact of economic, social and cultural capital on health in terms of diabetes and accelerated aging.
* Analyze the effect on diabetes and accelerated aging of the exposures assessed: body composition, physical activity, arterial rigidity, cognitive status, psychiatric disorders, fragility, pain.

Secondary endpoints specific to the main group: :

* Prevalence ratio of diabetes and prediabetes calculated for:

* Clinical, paraclinical parameters (Oral examination, Muscle strength,Advanced glycation products) and anthropometric parameters (medical history, height, weight, BMI, Waist and hip circumference, Neck circumference, body composition measurement, Systolic and diastolic blood pressure, Unipedal stance test).
* Biological (blood and genetic).
* Behavioural/environmental predictors: (socio-economic status, physical activity(RICCI GAGNON), diet(HDI), quality of life (MQLI), stress-anxiety(PSS), toxic habits, fragility(FRIED) ).
* Assessment of the level of ageing

* Biological Aging Marker: DNAmPhenoAge (DNA methylation phenotypic age)
* Accelerated ageing: age regression DNAmPhenoAge on chronological age
* Analysis of age-related parameters (inflammatory, renal, hormonal, body composition measurement, fragility, advanced glycation products, muscle strength) and correlation with methylation rate and DNAmPhenoAge.
* Prevalence ratio of (pre)diabetes and accelerated aging according to socio-economic status

* Evaluation of (pre)diabetes: fasting blood sugar
* Accelerated Aging Assessment: DNAm PhenoAge
* Social Status Assessment: EPICES Q1 to Q5 Score
* Assessment of economic status: Income level

Secondary endpoints specific to the subgroup:

* Risk (OR) of (pre)diabetes and accelerated aging according to social, economic, cultural and marital status

* Evaluation of (pre)diabetes: fasting blood sugar
* Accelerated Aging Assessment: DNAmPhenoAge
* Socio-economic and cultural criteria

* Social status (EPICES score)
* Economic status (income)
* Cultural status (semi-directive interview)
* Professional status (educational level, socio-professional category, marital status)
* Risk (OR) of (pre)diabetes and accelerated aging for assessed exposures:

* Evaluation of (pre)diabetes: fasting blood sugar
* Accelerated Aging Assessment: DNAmPhenoAge
* Exposure Assessment

* Arterial Stiffness Index
* Body composition (mineral density, lean mass, fat mass) (DEXA test)
* Insomnia Severity Index (ISI)
* Cognitive Status (MOCA)
* Physical Activity (GPAQ Questionnaire)
* Alcohol consumption (FACE)
* Psychiatric disorders (MINI)
* Fragility (REFS score)
* Pain Scale (EVA)

Conditions

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Diabetes PreDiabetes

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Main group

Cross-sectional study

Biological analysis, Physical examination and Questionnaires

Intervention Type OTHER

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

Sub group

Case control study

Physical examination and Questionnaires

Intervention Type OTHER

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.

Interventions

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Biological analysis, Physical examination and Questionnaires

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

Intervention Type OTHER

Physical examination and Questionnaires

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Participation in another clinical study or in a period of exclusion from another study
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Precision Diabetic Medicine,PreciDIAB

UNKNOWN

Sponsor Role collaborator

Institut Pasteur de Lille

OTHER

Sponsor Role lead

Responsible Party

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Jean-Michel Lecerf

Medical director of CPSL

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philippe Dr FROGUEL, PhD

Role: STUDY_CHAIR

PRECIDIAB

Matthias Mr VANDESQUILLE, PhD

Role: STUDY_DIRECTOR

PRECIDIAB

Locations

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Institut Pasteur de Lille

Lille, Hauts-de-France, France

Site Status

Countries

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France

Related Links

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https://www.precidiab.org/en/precidiab-national-center-for-precision-medicine-on-diabetes/

National Center for Precision Medicine on Diabetes - PreciDIAB

Other Identifiers

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2021-A01727-34

Identifier Type: -

Identifier Source: org_study_id

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