Study of Diabetes' Risk Factors and Accelerated Aging According to Socio-economic Status in a Population From the North of France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,014
- 试验地点
- 1
- 主要终点
- Fasting glucose value according to the level of precariousness
研究概览
简要总结
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).
详细描述
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •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
排除标准
- •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
结局指标
主要结局
Fasting glucose value according to the level of precariousness
时间窗: Day 0
Glycemia in g/L Level of precariousness given by EPICES score
次要结局
- Prevalence ratio of (pre)diabetes calculated for clinical, biological and behavioral/environmental explanatory variables(Day 0)
- Assessment of the level of accelerated ageing (DNAmPhenoAge)(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
Jean-Michel Lecerf
Medical director of CPSL
Institut Pasteur de Lille