Not Yet Recruiting

NCT Number: NCT06866002

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases PreDiabetes Prediabetic State

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Pasteur de Lille, Lille

Hauts de France, 59019, France

Location contact

Frédéric BATTEUX, Pr

CONTACT

[email protected]

0320877316

Frédéric BATTEUX, Pr

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participant in the PrévenDIAB study

Exclusion criteria

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

Treatment and study plan

Biological analysis, Physical examination and Questionnaires

Other

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

Physical examination and Questionnaires

Other

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.

Primary outcomes

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

Secondary outcomes

Prevalence ratio of (pre)diabetes calculated for clinical, biological and behavioral/environmental explanatory variables

Time frame: Day 0

In %
Prevalence ratio of (pre) diabetes and accelerated aging according to the socio-economic status

Time frame: Day 0

In %
Risk (odds Ratio) of (pre) diabetes and accelerated aging according to social, economic, cultural and professional status

Time frame: Until Day 90

Without units
Risk (odds Ratio) of (pre) diabetes and accelerated aging for assessed exposures

Time frame: Until Day 90

Without units

Study contacts

Contact information is provided by the study sponsor or research team.

Frédéric BATTEUX, Pr

CONTACT

[email protected]

0320877316

Sponsors and collaborators

Lead sponsor

Institut Pasteur de Lille

Other

Registry information

Acronym: PrévenDIAB 2

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Mar 10, 2025
Registry last updated: Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting

Pilot Study of "Bottarga" Supplementation: A Little-known, Sustainable "Blue" Food

NCT06988462

Body Weight, Diabetes

Sommerville, Massachusetts, United States

View Trial Details

Completed