Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT06866002
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-10
First Post:
2025-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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
Sponsor:
Institut Pasteur de Lille
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PrévenDIAB 2
Brief 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.
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: