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

NCT00257218 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2005-11-22

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Life style modification

Sponsors & Collaborators

  • National Science and Technology Council, Taiwan

    collaborator OTHER_GOV

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Jung-Nan Wei, Ph.D. · Chia Nan University of Pharmacy and Science

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-01-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00257218 on ClinicalTrials.gov