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临床试验/NCT01311401
NCT01311401Unknown不适用

Predictors of Future Type 2 Diabetes Mellitus in Circassians Minority in Israel

Ziv Hospital1 个研究点 分布在 1 个国家目标入组 670 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
670
试验地点
1
主要终点
New incidences of Type II Diabetes Mellitus in Circassians minority in Israel

研究概览

简要总结

The aim

The aim of the present study is:

  1. The metabolic risk factors that can predict diabetes after 10 years in a Circassians population-based sample of people who were aged 35 years or older and living in Israel.
  2. To define the incidence of type 2 diabetes mellitus in Circassians minority in Israel.

The hypothesis of the study:

High fasting glucose has the most powerful predictive value for type 2 diabetes mellitus in the future.

The claimed importance of the study:

Finding a powerful risk factor for future diabetes mellitus can contribute to intensifying the preventive measures in a small part of the population, by that to reduce the incidence of new diabetes without increasing the health cost.

详细描述

Research design and methods The present study is a 10 year, nested prospective cohort, population-based survey of the metabolic syndrome risk factors including type 2 diabetes mellitus. The original cross-sectional survey was conducted in two small Circassian villages in north Israel with 4000 inhabitants. The baseline evaluation was performed between 1996 and - 1997. Among the 739 randomly selected men (n=289) and women (n=450 of the 4000 individuals who were aged 35 years or older. Mean age of men was 53.2±11.8 years and of women was 52± years. Mean BMI for men and women was 27.5± and 29.4± Kg/m2, respectively. Plasma glucose level for men and women was mg/dL(22).

The investigators will recruit the same cohort in the proposed study and individuals who were free of diabetes at base line will be included. The number of deceased changed their residence and those who will decline to participate in the follow-up study will be reported.

The protocol was approved by the Ethics Committee of the Ziv hospital and all participants will give an informed consent.

Clinical data. Body mass index (BMI), fasting blood glucose, blood total cholesterol, triglycerides, low density cholesterol (LDL), high density cholesterol (HDL) and blood pressure measurements were done 10 years ago. In the present study, after 8 hours of caloric fast, blood glucose levels will be tested and patients will be asked about known recent diabetes mellitus in the last 10 years or treatment by dietary, hypoglycemic drugs or insulin.

Laboratory data. In the morning, after an overnight caloric fast, venous blood will be sampled for the measurement of plasma concentrations of glucose. The blood levels of glucose will be done by Olympus 640 at ZIV hospital. Diagnosis of diabetes. At baseline and at the 10-year follow-up, the presence of diabetes will be established according to World Health Organization (WHO) criteria (84), i.e., when fasting glucose will be ≥126 mg/dl or when the participants will have a clinical diagnosis of the disease and treatment was ongoing (diet, drugs).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Previous participation in similar study which was occured 10 years ago

排除标准

  • 未提供

结局指标

主要结局

New incidences of Type II Diabetes Mellitus in Circassians minority in Israel

时间窗: 14 years

次要结局

未报告次要终点

研究者

发起方
Ziv Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Osamah Hussein

Dr. Osamah Hussein

Ziv Hospital

研究点 (1)

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