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

Diabetes Clinical Trial

— PREVENDIAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05717491
• Other study ID #: 2021-A01727-34
• Status: Completed
• Start date: December 14, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: Institut Pasteur de Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2014
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• PreDiabetes

Intervention

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

Locations

Country	Name	City	State
France	Institut Pasteur de Lille	Lille	Hauts De France

Sponsors (2)

Lead Sponsor	Collaborator
Institut Pasteur de Lille	National Center for Precision Diabetic Medicine,PreciDIAB

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting glucose value according to the level of precariousness	Glycemia in g/L Level of precariousness given by EPICES score	Day 0
Secondary	Prevalence ratio of (pre)diabetes calculated for clinical, biological and behavioral/environmental explanatory variables	In %	Day 0
Secondary	Assessment of the level of accelerated ageing (DNAmPhenoAge)	In units of years	Day 0
Secondary	Prevalence ratio of (pre) diabetes and accelerated aging according to the socio-economic status	In %	Day 0
Secondary	Risk (odds Ratio) of (pre) diabetes and accelerated aging according to social, economic, cultural and professional status	Without units	Until Day 90
Secondary	Risk (odds Ratio) of (pre) diabetes and accelerated aging for assessed exposures	Without units	Until Day 90

External Links

•   National Center for Precision Medicine on Diabetes - PreciDIAB