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DEMOJUAN- DEMOnstration Area for Primary Prevention of Type 2 Diabetes, JUAN Mina and Barranquilla, Colombia (DEMOJUAN)

2016年7月25日 更新者:Centro de Investigacion Sanitaria

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

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

730

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Barranquilla、哥伦比亚
        • Camino Bosques de María
      • Barranquilla、哥伦比亚
        • Camino Sur Occidente El Pueblo
      • Barranquilla、哥伦比亚
        • Centro de INvestigacion Sanitaria
      • Barranquilla、哥伦比亚
        • Paso Las Malvinas
      • Barranquilla、哥伦比亚
        • Paso Nueva Era

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

34年 至 69年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Lifestyle intervention (nutrition)
The 200 study participants of this arm will first receive 6 months of nutritional counseling and thereafter combined nutrition/physical activity counseling during 18 month. The counseling sessions consists of monthly group seminars (10 participants/group) and totally 6 individual visits with a nutritionist and 6 visits with a physical activity expert.
The 200 study participants of this arm will first receive 6 months of Nutritional counseling and thereafter combined nutrition/physical activity counseling during 18 month. The counseling sessions consists of monthly group seminars (10 participants/group) and totally 6 individual visits with a nutritionist and 6 visits with a physical activity expert.
实验性的:Lifestyle counseling (physical activity)
The 200 study participants of this arm will first receive 6 months of physical activity counseling and thereafter combined nutrition/physical activity counseling during 18 month. The counseling sessions consists of monthly group seminars (10 participants/group) and totally 6 individual visits with a nutritionist and 6 visits with a physical activity expert.
The 200 study participants of this arm will first receive 6 months of physical activity counseling and thereafter combined nutrition/physical activity counseling during 18 month. The counseling sessions consists of monthly group seminars (10 participants/group) and totally 6 individual visits with a nutritionist and 6 visits with a physical activity expert.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The proportion of patients who reach normal levels of all glycaemic parameters.
大体时间: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
Month 24 of the intervention

次要结果测量

结果测量
措施说明
大体时间
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).
大体时间:Month 24 of the intervention
  • Proportion of patients whose blood pressure level is less than 130/80 mmHg
  • Proportion of patients whose serum HDL cholesterol level is more than 1.2 mmol/l
  • Proportion of patients whose serum LDL cholesterol level is less than 2.0 mmol/l
  • Proportion of patients whose total/HDL cholesterol ratio is less than 4.0
  • Proportion of patients whose weight reduction is more than 5%
Month 24 of the intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jaakko O Tuomilehto, MD, PhD、University of Helsinki
  • 学习椅:Tania Acosta, MD、CIIS LTDA
  • 学习椅:Noël C Barengo, MD, PhD, MPH、CIIS LTDA
  • 研究主任:Astrid Arrieta, MD、CIIS LTDA
  • 学习椅:Carlos Ricaurte、CIIS LTDA

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年2月1日

初级完成 (实际的)

2013年1月1日

研究完成 (实际的)

2015年3月1日

研究注册日期

首次提交

2011年2月12日

首先提交符合 QC 标准的

2011年2月14日

首次发布 (估计)

2011年2月15日

研究记录更新

最后更新发布 (估计)

2016年7月26日

上次提交的符合 QC 标准的更新

2016年7月25日

最后验证

2016年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • LT09-258

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

The study group is ready to share the data in de-identified format once the main results have been reported or in case any journal may ask for the data to run a check.

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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