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


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Health Promotion / Disease Prevention / Safety



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

This study is not yet open for patient recruitment.
Verified by National Taiwan University Hospital November 2005

Sponsors and Collaborators: National Taiwan University Hospital
National Science Council, Taiwan
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00257218

Purpose

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 Intervention
Diabetes Mellitus
 Behavior: Life style modification

MedlinePlus related topics:  Diabetes

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Placebo Control, Factorial Assignment, Efficacy Study

Further study details as provided by National Taiwan University Hospital:
Primary Outcomes: Incidence of diabetes mellitus
Secondary Outcomes: insulin sensitivity
Expected Total Enrollment:  1000

Study start: January 2006

Eligibility

Ages Eligible for Study:  40 Years   -   60 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00257218

Hung-Yuan Li, Ph.D      05-5323911  Ext. 5775    p91421007@ntu.edu.tw

Taiwan
      Chia Nan University of Pharmacy and Science, Tainan,  717,  Taiwan

Study chairs or principal investigators

Jung-Nan Wei, Ph.D.,  Principal Investigator,  Chia Nan University of Pharmacy and Science   

More Information

Study ID Numbers:  9461701008
Last Updated:  December 8, 2005
Record first received:  November 21, 2005
ClinicalTrials.gov Identifier:  NCT00257218
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2006-01-10

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Page Updated: September 17, 2004
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