A Study on Effect of Health Promotion for Prevention NIDDM in People With Prediabetes
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|ClinicalTrials.gov Identifier: NCT00257218|
Recruitment Status : Unknown
Verified November 2005 by National Taiwan University Hospital.
Recruitment status was: Not yet recruiting
First Posted : November 22, 2005
Last Update Posted : November 22, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Behavioral: Life style modification||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1000 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2006|
- Incidence of diabetes mellitus
- insulin sensitivity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00257218
|Contact: Hung-Yuan Li, Ph.D||05-5323911 ext firstname.lastname@example.org|
|Chia Nan University of Pharmacy and Science|
|Tainan, Taiwan, 717|
|Principal Investigator:||Jung-Nan Wei, Ph.D.||Chia Nan University of Pharmacy and Science|