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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2006

Primary Outcome Measures :
  1. Incidence of diabetes mellitus

Secondary Outcome Measures :
  1. insulin sensitivity

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00257218

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Contact: Hung-Yuan Li, Ph.D 05-5323911 ext 5775

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Chia Nan University of Pharmacy and Science
Tainan, Taiwan, 717
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
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Principal Investigator: Jung-Nan Wei, Ph.D. Chia Nan University of Pharmacy and Science
Layout table for additonal information Identifier: NCT00257218    
Other Study ID Numbers: 9461701008
First Posted: November 22, 2005    Key Record Dates
Last Update Posted: November 22, 2005
Last Verified: November 2005