DiabetesPrévenDIAB 2NCT06866002
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
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 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. 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
- 2,011 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 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.
Who may be able to join
- Participant in the PrévenDIAB study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Institut Pasteur de Lille, Lille
Hauts de France, 59019
Frédéric BATTEUX, Pr, 0320877316, frederic.batteux@pasteur-lille.fr
Frédéric BATTEUX, Pr
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Diabetes, Prediabetes
- Being tested
- Biological analysis, Physical examination and Questionnaires, Physical examination and Questionnaires
- Keywords
- Risk factors, Precarious, Accelerated aging, (Pre) diabetes
- 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 (arterial stiffness) for the patients of the subgroup and others questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Main Group | observational descriptive cohort 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 blood 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
Measured: Day 0
Secondary outcomes (4)
Prevalence ratio of (pre)diabetes calculated for clinical, biological and behavioral/environmental explanatory variables
In %
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 posted10 Mar 2025
- Study start5 Mar 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,011 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur de Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Coralie BERTHIER, Institut Pasteur de Lille
- Investigators
- Philippe FROGUEL, Study chair, PhD PRECIDIABMatthias VANDESQUILLE, Study director, PhD PRECIDIAB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866002
- Sponsor's protocol ID
- 2024-A02836-41
- Acronym
- PrévenDIAB 2
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 10 Mar 2025
- 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 10 Mar 2025. 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 - 3-year Follow-up
- ClinicalTrials.gov ID
- NCT06866002
- Acronym / sponsor ID
- PrévenDIAB 2 / 2024-A02836-41
- Conditions
- Diabetes, Prediabetes
- Keywords
- Risk factors, Precarious, Accelerated aging, (Pre) diabetes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,011 participants (estimated)
- Lead sponsor
- Institut Pasteur de LilleUniversity, hospital or other
- Study start
- 5 Mar 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Mar 2025 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main Group | – | Other: Biological analysis, Physical examination and Questionnairesobservational descriptive cohort |
| 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 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.
Key inclusion criteria (1 listed)
- Participant in the PrévenDIAB study
Key exclusion criteria (3 listed)
- 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
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 (arterial stiffness) for the patients of the subgroup and others questionnaires. | Other | Sub group |
Primary outcome
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
4 secondary outcomes
Prevalence ratio of (pre)diabetes calculated for clinical, biological and behavioral/environmental explanatory variables
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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- 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.
Philippe FROGUEL study chair
PhD PRECIDIAB
Matthias VANDESQUILLE study director
PhD 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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 10 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frédéric BATTEUX, Pr (0320877316, frederic.batteux@pasteur-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting blood glucose and Hb1Ac (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 10 Mar 2025.