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临床试验/NCT02542722
NCT02542722已完成不适用

Prevention of Type 2 Diabetes Mellitus (Egabro-Pizarra Study)

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud0 个研究点目标入组 390 人开始时间: 2009年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
390
主要终点
Incidence of type 2 diabetes in subjects at risk

研究概览

简要总结

It will be selected 1274 subject older than 40 years of the population of Cabra in order to realize a sociodemographic and habits (toxic, food, of physical activity) survey. It will be realized a physical exploration including anthropometry, blood pressure, oral glucose tolerance test, blood extractions (basal and after 120 ' of the OGTT). Several biochemical determinations will be realized (p.e. marker of fat intake and marker of inflammation) The proposed intervention consists of a series of clinical visits and phone calls programmed with the aim to change the dietetic and physical activity habits of people. The Pizarra study (financed with other grants and realised with the same methodology) will be use as cohort control. Though the basic aim of the project is to achieve a reduction of the of diabetes incidence with a hygienic - sanitary intervention, the ambition of knowing the major number of possible factors that can participate in this process constitutes a complex project capable of analyzing the problem from diverse points of view. Endocrinologists (of two Andalusian hospitals), clinical biochemists, geneticists and dietitians they join in this project to approach an integral way the etiopathogeny of the diabetes type 2.

详细描述

  1. Intervention study population: Egabro Study. This study commenced in 2009 in Cabra, a town of 20,000 inhabitants located in the Subbética region of Cordoba Province (Spain). The study includes persons aged over 40 years.
  2. Control population: Pizarra Study. The Pizarra Study is in progress since 1995. The details of this study have been the subject of multiple publications (see CVs). The start of the Egabro Study coincided with the third evaluation of the Pizarra cohort, as well as the extension of the population base, which will now enable the whole population of Pizarra aged over 40 years to be studied.
  3. Design: A prospective cohort study with exposure to an intervention on hygiene and health habits:

Cohort A. Egabro Study:

First phase: Cross-sectional prevalence study Second phase: Intensive intervention study in certain risk groups (Cohort study, with a control group)

Cohort B. Pizarra Study:

First phase: Prevalence study (cross-sectional, extension of the initial cohort) Second phase: Follow-up of the cohort, to be used as a control group for the intervention study in the Egabro project 4. Subjects susceptible to the intervention:

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
None

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •impaired fasting glucose and/or impaired oral glucose tolerance test.

排除标准

  • •type 2 diabetes mellitus previously diagnosed. In the last 6 months: serious illness or surgery, delivery or breastfeeding.

研究组 & 干预措施

Control

Active Comparator

General dietary and physical exercise recommendations

干预措施: Control (Behavioral)

Intervention

Experimental

Intensive intervention on dietary and physical exercise habits.

干预措施: Intensive Intervention (Behavioral)

结局指标

主要结局

Incidence of type 2 diabetes in subjects at risk

时间窗: 12 and 24 months

Incidence (at 12 and 24 months) of type 2 diabetes diagnosed by oral glucose tolerance test (OGTT) according WHO criteria in subjects with impaired OGTT.

次要结局

未报告次要终点

研究者

发起方
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
申办方类型
Other
责任方
Sponsor

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