Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05717491 |
| Other study ID # |
2021-A01727-34 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 14, 2021 |
| Est. completion date |
March 31, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Institut Pasteur de Lille |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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).
Description:
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)
Secondary Objectives specific to the main group:
- Characterize the population and analyze the risk factors (clinical, biological,
socio-economic and behavioural) of diabetes and prediabetes in this population.
- Study the level of biological ageing and factors associated with accelerated ageing.
- Estimate the risk of (pre)diabetes and accelerated aging based on socio-economic
profile.
Secondary Objectives specific to the sub-group:
- Assess the impact of economic, social and cultural capital on health in terms of
diabetes and accelerated aging.
- Analyze the effect on diabetes and accelerated aging of the exposures assessed: body
composition, physical activity, arterial rigidity, cognitive status, psychiatric
disorders, fragility, pain.
Secondary endpoints specific to the main group: :
- Prevalence ratio of diabetes and prediabetes calculated for:
- Clinical, paraclinical parameters (Oral examination, Muscle strength,Advanced
glycation products) and anthropometric parameters (medical history, height, weight,
BMI, Waist and hip circumference, Neck circumference, body composition measurement,
Systolic and diastolic blood pressure, Unipedal stance test).
- Biological (blood and genetic).
- Behavioural/environmental predictors: (socio-economic status, physical
activity(RICCI GAGNON), diet(HDI), quality of life (MQLI), stress-anxiety(PSS),
toxic habits, fragility(FRIED) ).
- Assessment of the level of ageing
- Biological Aging Marker: DNAmPhenoAge (DNA methylation phenotypic age)
- Accelerated ageing: age regression DNAmPhenoAge on chronological age
- Analysis of age-related parameters (inflammatory, renal, hormonal, body composition
measurement, fragility, advanced glycation products, muscle strength) and
correlation with methylation rate and DNAmPhenoAge.
- Prevalence ratio of (pre)diabetes and accelerated aging according to socio-economic
status
- Evaluation of (pre)diabetes: fasting blood sugar
- Accelerated Aging Assessment: DNAm PhenoAge
- Social Status Assessment: EPICES Q1 to Q5 Score
- Assessment of economic status: Income level
Secondary endpoints specific to the subgroup:
- Risk (OR) of (pre)diabetes and accelerated aging according to social, economic, cultural
and marital status
- Evaluation of (pre)diabetes: fasting blood sugar
- Accelerated Aging Assessment: DNAmPhenoAge
- Socio-economic and cultural criteria
- Social status (EPICES score)
- Economic status (income)
- Cultural status (semi-directive interview)
- Professional status (educational level, socio-professional category, marital
status)
- Risk (OR) of (pre)diabetes and accelerated aging for assessed exposures:
- Evaluation of (pre)diabetes: fasting blood sugar
- Accelerated Aging Assessment: DNAmPhenoAge
- Exposure Assessment
- Arterial Stiffness Index
- Body composition (mineral density, lean mass, fat mass) (DEXA test)
- Insomnia Severity Index (ISI)
- Cognitive Status (MOCA)
- Physical Activity (GPAQ Questionnaire)
- Alcohol consumption (FACE)
- Psychiatric disorders (MINI)
- Fragility (REFS score)
- Pain Scale (EVA)
