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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Behavioral: Life style modification

• Study Type: Interventional
• Enrollment: 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of diabetes mellitus

Secondary Outcome Measures

Outcome Measure
insulin sensitivity

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Science Council, Taiwan
• Investigators: Principal Investigator: Jung-Nan Wei, Ph.D., Chia Nan University of Pharmacy and Science

Study record dates

Study Major Dates

• Study Start: January 1, 2006

Study Registration Dates

• First Submitted: November 21, 2005
• First Submitted That Met QC Criteria: November 21, 2005
• First Posted (Estimate): November 22, 2005

Study Record Updates

• Last Update Posted (Estimate): November 22, 2005
• Last Update Submitted That Met QC Criteria: November 21, 2005
• Last Verified: November 1, 2005

More Information

Terms related to this study

• Other Study ID Numbers: 9461701008