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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,011
- 试验地点
- 1
- 主要终点
- fasting blood glucose and Hb1Ac
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant in the PrévenDIAB study
排除标准
- •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
结局指标
主要结局
fasting blood glucose and Hb1Ac
时间窗: 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
次要结局
- Prevalence ratio of (pre)diabetes calculated for clinical, biological and behavioral/environmental explanatory variables(Day 0)
- Prevalence ratio of (pre) diabetes and accelerated aging according to the socio-economic status(Day 0)
- Risk (odds Ratio) of (pre) diabetes and accelerated aging according to social, economic, cultural and professional status(Until Day 90)
- Risk (odds Ratio) of (pre) diabetes and accelerated aging for assessed exposures(Until Day 90)
研究者
Coralie BERTHIER
Research prevention center manager
Institut Pasteur de Lille