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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05325710
Other study ID # 2021-A00375-36
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 20, 2022
Est. completion date April 1, 2028

Study information

Verified date March 2022
Source Ramsay Générale de Santé
Contact JF OUDET
Phone 068346567
Email jf.oudet@ecten.eu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In France, the overall prevalence of diabetes was estimated at 5% of population in 2016, type 2 diabetes (T2DM) corresponding to 90% of cases. However, this figure is greatly underestimated,since it does not take into account people who are untreated or not diagnosed. However,it is estimated that 20 to 30% of adults with diabetes do not are not diagnosed. Conclusions presented during the annual meeting of the european Association for the Study of diabetes (EASD-Berlin) from 2019 suggest that signs precursors of the disease would be present up to 20 years before the diagnosis. The Diagnosis is usually made around 40-50 years. The main factor of risk of T2D is the lifestyle, in particular a diet too rich for a too sedentary daily life. From a medico-economic point of view, chronic pathologies (including diabetes) account for 60% of insurance expenditure illness even though they concern 35% of insured persons, i.e. 20 million patients. The average annual repayment of a type 2 diabetic patient is 4890 euros. This study is part of this context as the starting point a reflection on a different, coordinated management, to know a preventive rather than a curative approach.


Description:

In France, the overall prevalence of diabetes was estimated at 5% of population in 2016, type 2 diabetes (T2DM) corresponding to 90% of cases. However, this figure is greatly underestimated. since it does not take into account people who are untreated or not diagnosed. However, given the silent nature of the disease, it is estimated that 20 to 30% of adults with diabetes do not are not diagnosed. This share decreases with age, falling to 13% among 55-74 year olds. Conclusions presented during the annual meeting of the european Association for the Study of diabetes (EASD-Berlin) from 2019 suggest that signs precursors of the disease would be present up to 20 years before the diagnosis. Type 2 diabetes, or non-insulin dependent diabetes, is a metabolic disease characterized by a chronic excess of sugar in the blood, affecting both men and women. the Diagnosis is usually made around 40-50 years. The main factor of risk of T2D is the lifestyle, in particular a diet too rich for a too sedentary daily life. The direct consequences are an increase in obesity hich is itself a major risk factor for the development of T2D. Among the risk factors, we also find hyperlipidemia, high blood pressure, high blood sugar fasting, stress, smoking, heredity, family history of diabetes, or gestational diabetes. From a medico-economic point of view, chronic pathologies (including diabetes) account for 60% of insurance expenditure illness even though they concern 35% of insured persons, i.e. 20 million patients. The average annual repayment of a type 2 diabetic patient is 4890 euros.This study is part of this context as the starting point a reflection on a different, coordinated management, to know a preventive rather than a curative approach.


Recruitment information / eligibility

Status Recruiting
Enrollment 230
Est. completion date April 1, 2028
Est. primary completion date April 1, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Patient, male or female, over the age of 18 - Patient with a FINDRISC score =10 points - Beneficiary of a French health insurance system - Patient having been informed and having given their consent free, enlightened and written Exclusion Criteria: - Patient over 75 years old - Patient already diagnosed with type 2 diabetes - Patient whose physical and/or psychological health is severely impaired, which according to the investigator may affect the compliance of the study participant. - Patient participating in another research - Patient in period of exclusion from another research always in progress at the time of inclusion. - Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by court order or administration. - Pregnant, breastfeeding or parturient women. - Patient hospitalized without consent

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Study nurse intervention
Contact everay 4 months with a dedicated study nurse

Locations

Country Name City State
France Clinique Aguiléra Biarritz Aquitaine

Sponsors (2)

Lead Sponsor Collaborator
Ramsay Générale de Santé European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary FINDRISC score FINDRISC is a prediction tool to identify patients at risk of developing diabetes without biological analysis. 5 years
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