A Study on Effect of Health Promotion for Prevention NIDDM in People With Prediabetes
1 other identifier
interventional
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2005
CompletedFirst Posted
Study publicly available on registry
November 22, 2005
CompletedStudy Start
First participant enrolled
January 1, 2006
CompletedNovember 22, 2005
November 1, 2005
November 21, 2005
November 21, 2005
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of diabetes mellitus
Secondary Outcomes (1)
insulin sensitivity
Interventions
Eligibility Criteria
You may qualify if:
- fasting glucose level 100-125mg/dl
- OGTT 2hr glucose level 140-199 mg/dl
You may not qualify if:
- established diabetes mellitus: use of diabetic medication, fasting glucose \>=126 mg/dl, OGTT 2ht glucose level \>=200mg/dl
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chia Nan University of Pharmacy and Science
Tainan, 717, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jung-Nan Wei, Ph.D.
Chia Nan University of Pharmacy and Science
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 21, 2005
First Posted
November 22, 2005
Study Start
January 1, 2006
Last Updated
November 22, 2005
Record last verified: 2005-11