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

NCT ID: NCT00257218

Last Updated: 2005-11-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Life style modification

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Jung-Nan Wei, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chia Nan University of Pharmacy and Science

Locations

Chia Nan University of Pharmacy and Science

Tainan City, , Taiwan

Countries

Taiwan

Central Contacts

Hung-Yuan Li, Ph.D

Role: CONTACT

Phone: 05-5323911

Email: p91421007@ntu.edu.tw

Other Identifiers

9461701008

Identifier Type: -

Identifier Source: org_study_id