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临床试验/NCT01296100
NCT01296100已完成不适用

DEMOnstration Area for Primary Prevention of Type 2 Diabetes, JUAN Mina and Barranquilla, Colombia

Centro de Investigacion Sanitaria5 个研究点 分布在 1 个国家目标入组 730 人开始时间: 2011年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
730
试验地点
5
主要终点
The proportion of patients who reach normal levels of all glycaemic parameters.

研究概览

简要总结

The main aim of this study is to investigate to what extent it is possible to reach normal glucose metabolism and optimal cardiovascular disease (CVD) risk factor levels with early lifestyle interventions in people at high risk of type 2 diabetes compared with those who receive standard therapy (usual care) only.

The project will show the effect of these interventions for the first time in people of low socio-economic levels living in a Caribbean environment.

详细描述

Type 2 diabetes (T2D) is one of the fastest growing public health problems in both developed and developing countries. The development of T2D is a slow process and involves both genetic and environmental effects. It is commonly agreed that T2D may develop only in people that carry a genetic predisposition to the disease. Based on epidemiological observations about half of the people will develop T2D during their lifetime, and up to 30-35% will have IGT. Therefore, it is likely that more than half of the population carry genes that predispose the development of T2D. In people genetically predisposed to the disease, the probability to develop T2D is very high once exposed to unhealthy lifestyles such as obesity, unbalanced diet and physical inactivity. While we cannot change the genes, the only way to prevent T2D and its serious complications is the modification of lifestyle risk factors. Therefore, it is very important to understand the role of preventive lifestyle intervention as a key treatment in T2D prevention. Once established, T2D is difficult to treat. Despite pharmacologic treatment blood glucose levels trend to increase over time. Thus, the most efficient way to manage T2D is to prevent diabetes from developing. Also complications of T2D can best be postponed by postponing the onset of the primary disease itself. The efforts to prevent the disease need to start as early as possible and address all susceptibility factors. Fortunately, recent studies have convincingly demonstrated that prevention of T2D is possible. This project will show for the first time how lifestyle interventions work in people with IGT in the Caribbean population. The results of this study will be sued for policy making and planning of primary prevention activities not only in the local health-care system but in the entire Caribbean region.

研究设计

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

入排标准

年龄范围
34 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 34-69 years-of-age with diagnosed IGT
  • Informed consent given.

排除标准

  • Patients with pharmacologically-treated diabetes
  • Hypertriglyceridaemia under drug treatment
  • History of life-limiting diseases or events
  • Unwillingness to sign the informed consent.

结局指标

主要结局

The proportion of patients who reach normal levels of all glycaemic parameters.

时间窗: Month 24 of the intervention

* Proportion of patients whose fasting glucose level is less than 6.1 mmol/l * Proportion of patients whose 2-hour glucose level is less than 7.8 mmol/l

次要结局

  • Difference in reduction of 10 year-estimated cardiovascular risk score of 10% between the standard therapy control group and the lifestyle intervention groups (WHO CVD prediction chart).(Month 24 of the intervention)

研究者

发起方
Centro de Investigacion Sanitaria
申办方类型
Network
责任方
Sponsor

研究点 (5)

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