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临床试验/NCT04463160
NCT04463160招募中不适用

Study of the Factors Favoring the Transition From Prediabetes to Diabetes on Reunion Island. Impact of the "Say No to Diabetes" Intervention.

Centre Hospitalier Universitaire de la Réunion1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2019年7月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
1
主要终点
The impact of the "Say No to Diabetes" intervention on the incidence of type 2 diabetes

研究概览

简要总结

The management of diabetes and its complications in Reunion island is one of the priority areas of health. Indeed, the impact of diabetes on the health of the Reunion island population is major: the prevalence of diabetes treated in Reunion island is the highest in France (10% of the population), and gestational diabetes is found in 10% of pregnancies. Reunionese diabetics develop severe complications, in particular cardiovascular (strokes, myocardial infarction).

This results in 3 times higher mortality linked to diabetes on Reunion Island, in particular among those under 65 years of age. Despite all the screening and prevention programs put in place, the weight of diabetic disease continues to increase in our island, and this is more accelerated than in the other French departments with 4,300 new cases of diabetes / year, 95% of which type 2 diabetics (T2D). The presentation of type 2 diabetic patients in Reunion island also differs from the Metropolis with subjects more often female (56%), thinner and younger at the discovery of diabetes. These data highlight the need to better understand the factors underlying the diabetes "epidemic" in Reunion island.

The rise in blood sugar until the onset of diabetes is a continuous phenomenon reflecting the progressive suffering of the organs used to maintain carbohydrate homeostasis. Thus, we talk about fasting hyperglycemia when the fasting blood sugar is between 1.10 and 1.25 g / L (6.1-6.9 mmol / l) and glucose intolerance when the blood sugar 2 hours after taking 75 g of glucose is between 1.40 and 1.99 g / L (7.8-11.0 mmol / l). Subjects with fasting hyperglycemia or glucose intolerance constitute the target population at very high risk of developing diabetes (up to 70% of these subjects). They have an increased risk of developing diabetes at 1 year multiplied by 5 to 10 compared to normoglycemic subjects, hence the name "prediabetic subjects". This great variability in the risk of developing diabetes highlights the presence of associated risk / protective factors which it is important to find in order to adapt the monitoring and management. It is important in Reunion island, in view of the specificities presented by our population, to understand the pre-diabetes / diabetes transition and the risk and protective factors.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Subject aged 25 to 70 with pre-diabetes defined by fasting blood sugar between 1.10 and 1.25 g / l (6.1 and 6.9 mmol / l) or blood sugar between 1.40 and 1.99 g / l (7.8 and 11.0 mmol / l) 2 hours after taking 75g of glucose (HGPO test), dating from less than 3 months.
  • •Consulting one of the general practitioners involved in the study, whatever the initial reason for the consultation
  • •able to answer a telephone survey questionnaire
  • •who have never been diagnosed or treated for diabetes with the exception of gestational diabetes
  • •Person affiliated or beneficiary of a social security scheme.
  • •Free, informed and written consent signed

排除标准

  • •People likely to leave Reunion within 2 years
  • •Persons placed under guardianship, curators, safeguard of justice, person participating in another research including an exclusion period still in progress.
  • •Person with severely impaired physical and / or psychological health, who, according to the investigator, may affect the compliance of the study participant.
  • •Pregnancy in progress

研究组 & 干预措施

prevention program for prediabetes "Say No to Diabetes"

Experimental

干预措施: prevention program for prediabetes "Say No to Diabetes" (Other)

No prevention program

No Intervention

结局指标

主要结局

The impact of the "Say No to Diabetes" intervention on the incidence of type 2 diabetes

时间窗: 2 years

Diabetes : fasting blood glucose ≥ 1.26 g / l (7 mmol / l), or blood sugar 2 hours after taking 75 g of glucose during HGPO ≥2 g / l (11.1 mmol / l)

次要结局

  • Numer of patients with diagnosic of type 2 diabetes in subjects identified as pre-diabetic(2 years)
  • Number of patients return to normal blood sugar(2 years)
  • HbA1c assay for the diagnosis of glucose intolerance and prediabetes compared to HGPO(2 years)

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

研究点 (1)

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