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临床试验/NCT00257218
NCT00257218Unknown不适用

A Study on Effect of Health Promotion for Prevention NIDDM in People With Prediabetes

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2006年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
2
主要终点
Incidence of diabetes mellitus

研究概览

简要总结

OBJECTIVE - The role of health promotion for patients with impaired fasting glucose on preventing or delay the progression of diabetes mellitus has not been widely investigated in Taiwan. The purposes of this study are to explore the nature history of prediabetes, to evaluate the incidence of DM in prediabetes and to establish the cohort of people with prediabetes. Further study will be based on this cohort to evaluate the effect of health promotion and to compare the concentration of certain protein in their serum, such as adiponectin.

RESEARCH DESIGN AND METHODS -A total of 600 subjects aged 40-60 years with impaired fasting glucose (100-125 mg/dl) were randomly selected from the Peng-Hu clinics during January 2003 and December 2003. Anthropometric, biochemical, and metabolic characteristics will be measured, including weight, height, waist circumference, oral glucose tolerance test, triglyceride, high and low density cholesterol, blood pressure and insulin resistance etc. A questionnaire interviews with subjects regarding demographic characteristics is also performed. 300 subjects will receive education of health promotion. Simultaneously, 150 subjects with normal fasting plasma glucose (<100 mg/dl) will selected for comparison.

Statistical Analysis - Descriptive data will be described as means and SDs for continuous variables, and analysis of variance (ANOVA) and Chi-square tests were used for assessing the significances. Bonferroni method was used for post-hoc comparison in ANOVA. Multiple linear regressions were used for predicting determinants of FPG. We tested the variables scales in this study for multicollinearity by correlation matrix and VIF (variance inflation factor). Odds ratios (ORs) and the 95% confidence interval (CI) were calculated to estimate the relative risk of diabetes mellitus by logistic regression model. A p-value below 0.05 was considered significant. The statistical analyses were performed with SPSS statistical Package.

研究设计

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

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • fasting glucose level 100-125mg/dl
  • OGTT 2hr glucose level 140-199 mg/dl

排除标准

  • established diabetes mellitus: use of diabetic medication, fasting glucose >=126 mg/dl, OGTT 2ht glucose level >=200mg/dl

结局指标

主要结局

Incidence of diabetes mellitus

次要结局

  • insulin sensitivity

研究者

申办方类型
Other

研究点 (2)

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