Diabetes Mellitus Clinical Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
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