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临床试验/NCT04907760
NCT04907760尚未招募不适用

Personalized Follow-up Program in the Type 2 Diabetes Prevention

GCS Ramsay Santé pour l'Enseignement et la Recherche0 个研究点目标入组 230 人开始时间: 2021年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
230
主要终点
Risk factors for type 2 diabetes in participants

研究概览

简要总结

In France, the global prevalence of diabetes was estimated to 5% of the population in 2016, the type two diabetes (DT2) corresponding to 90% of cases. This number is widely underestimated because most people are untreated and undiagnosed. Due to the silent character of this disease, it is estimated that 20 à 30 % of diabetic adults have not yet been diagnosed. The conclusions, presented during the annual meeting of EASD in 2019, suggest that the precursor signs of this disease could be present until 20 years before the diagnosis.

Diabetes is a metabolic disease and people are diagnosed, in general, around 40-50 years old. The main risk factor of type II diabetes is lifestyle (rich diet, sedentary) but there is also other factors like hyperlipidemia, high blood pressure, high fasting blood sugar, stress, smoking, heredity, family history of diabetes, or gestational diabetes. This induces an increase of obesity, itself a major risk factor for type II diabetes occurrence.

From an economical aspect, chronic pathologies (including diabetes) represent 60% of health insurance expenses, even though it concerns 35% of insured persons, i.e. 20 million of patients. The average of annual reimbursement for a type 2 diabetic patient is 4890 euros. In this context, this study is the first step of thinking about a different, coordinated care approach, based on a preventive rather than curative approach.

详细描述

This study includes a personalized care program, including the patient follow-up by a nurse during 5 years with a contact every 4 months for the first year, then after every 6 months. The nurse will review the patient's progress and provide advice and contact with professionals: physical activity, psychologists, dieticians, endocrinologists, etc The main objective of this study is to compare, after 5 years of follow-up, the risk factors associated with type 2 diabetes, between participants who received personalized follow-up and those who did not. The secondary objectives are to compare the occurrence of type 2 diabetes, the quality of life and the compliance to the program between participants who received personalized follow-up and those who did not.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Person with a FINDRISC score ≥ 10 points
  • Person who has given his/her express written and informed consent

排除标准

  • Person already diagnosed with a type 2 diabetes

结局指标

主要结局

Risk factors for type 2 diabetes in participants

时间窗: 5 years

Finnish Diabetes Risk Score (FINDRISC score) : 8 items with a total score from 0 to 26 points with 0 (no risk factor) and 26 (highest risk factor)

次要结局

  • Diabetes diagnostic(at 5 years)
  • program compliance(during 5 years)
  • The Quality of Life(at 5 years)

研究者

发起方
GCS Ramsay Santé pour l'Enseignement et la Recherche
申办方类型
Other
责任方
Sponsor

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