DiabetesPREVENDIABNCT05717491
Study of Diabetes' Risk Factors and Accelerated Aging According to Socio-economic Status in a Population From the North of France
An observational study of Diabetes and PreDiabetes, run by Institut Pasteur de Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, PreDiabetes
- What is being tested?
- Biological analysis, Physical examination and Questionnaires and Physical examination and Questionnaires
- How many people
- 2,014 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2021to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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).
Read the detailed 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)
- Conditions
- Diabetes, PreDiabetes
- Being tested
- Biological analysis, Physical examination and Questionnaires, Physical examination and Questionnaires
- Keywords
- (Pre) diabetes, Risk factors, Precarious, Accelerated aging
- Medical subject headings
- Diabetes Mellitus, Prediabetic State, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological analysis, Physical examination and QuestionnairesOther
Biological analysis, Physical examination and questionnaires will be performed for all patients of the main group.
Physical examination and QuestionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Main group | Cross-sectional study Receives: Other: Biological analysis, Physical examination and Questionnaires | |
| Sub group | Case control study Receives: Other: Physical examination and Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glucose value according to the level of precariousness
Glycemia in g/L Level of precariousness given by EPICES score
Measured: Day 0
Secondary outcomes (5)
Prevalence ratio of (pre)diabetes calculated for clinical, biological and behavioral/environmental explanatory variables
In %
Measured: Day 0
Assessment of the level of accelerated ageing (DNAmPhenoAge)
In units of years
Measured: Day 0
Prevalence ratio of (pre) diabetes and accelerated aging according to the socio-economic status
In %
Measured: Day 0
Risk (odds Ratio) of (pre) diabetes and accelerated aging according to social, economic, cultural and professional status
Without units
Measured: Until Day 90
Risk (odds Ratio) of (pre) diabetes and accelerated aging for assessed exposures
Without units
Measured: Until Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start14 Dec 2021
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,014 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur de Lille
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Precision Diabetic Medicine,PreciDIAB
- Responsible party
- Principal investigator, Jean-Michel Lecerf, Institut Pasteur de Lille
- Investigators
- Philippe Dr FROGUEL, PhD, Study chair, PRECIDIABMatthias Mr VANDESQUILLE, PhD, Study director, PRECIDIAB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717491
- Sponsor's protocol ID
- 2021-A01727-34
- Acronym
- PREVENDIAB
- Status last verified
- Apr 2024
- First submitted
- 14 Dec 2021
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Diabetes' Risk Factors and Accelerated Aging According to Socio-economic Status in a Population From the North of France
- ClinicalTrials.gov ID
- NCT05717491
- Acronym / sponsor ID
- PREVENDIAB / 2021-A01727-34
- Conditions
- Diabetes, PreDiabetes
- Keywords
- (Pre) diabetes, Risk factors, Precarious, Accelerated aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,014 participants (actual)
- Lead sponsor
- Institut Pasteur de LilleUniversity, hospital or other
- Collaborators
- National Center for Precision Diabetic Medicine,PreciDIAB
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main group | – | Other: Biological analysis, Physical examination and QuestionnairesCross-sectional study |
| Sub group | – | Other: Physical examination and QuestionnairesCase control study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological analysis, Physical examination and QuestionnairesBiological analysis, Physical examination and questionnaires will be performed for all patients of the main group. | Other | Main group |
| Physical examination and QuestionnairesIn 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. | Other | Sub group |
Primary outcome
Fasting glucose value according to the level of precariousness
Time frame: Day 0
Glycemia in g/L Level of precariousness given by EPICES score
5 secondary outcomes
Prevalence ratio of (pre)diabetes calculated for clinical, biological and behavioral/environmental explanatory variables
Time frame: Day 0
Assessment of the level of accelerated ageing (DNAmPhenoAge)
Time frame: Day 0
Prevalence ratio of (pre) diabetes and accelerated aging according to the socio-economic status
Time frame: Day 0
Risk (odds Ratio) of (pre) diabetes and accelerated aging according to social, economic, cultural and professional status
Time frame: Until Day 90
Risk (odds Ratio) of (pre) diabetes and accelerated aging for assessed exposures
Time frame: Until Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- National Center for Precision Medicine on Diabetes - PreciDIABLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Dr FROGUEL, PhD study chair
PRECIDIAB
Matthias Mr VANDESQUILLE, PhD study director
PRECIDIAB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and PreDiabetes, run by Institut Pasteur de Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting glucose value according to the level of precariousness (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.