Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257218
Status:
UNKNOWN
Last Update Posted:
2005-11-22
First Post:
2005-11-21
Brief Title:
A Study on Effect of Health Promotion for Prevention NIDDM in People With Prediabetes
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2005-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgdl 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 mgdl 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 005 was considered significant The statistical analyses were performed with SPSS statistical Package
RESEARCH DESIGN AND METHODS -A total of 600 subjects aged 40-60 years with impaired fasting glucose 100-125 mgdl 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 mgdl 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 005 was considered significant The statistical analyses were performed with SPSS statistical Package
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None