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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by National Taiwan University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00257218
First received: November 21, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted

November 21, 2005
November 21, 2005
January 2006
 
Incidence of diabetes mellitus
Same as current
No Changes Posted
insulin sensitivity
Same as current
 
 
 
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.

 
Interventional
 
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Diabetes Mellitus
Behavioral: Life style modification
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1000
 
 

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
Both
40 Years to 60 Years
Yes
Contact: Hung-Yuan Li, Ph.D 05-5323911 ext 5775 p91421007@ntu.edu.tw
Taiwan
 
NCT00257218
9461701008
 
 
National Taiwan University Hospital
National Science Council, Taiwan
Principal Investigator: Jung-Nan Wei, Ph.D. Chia Nan University of Pharmacy and Science
National Taiwan University Hospital
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP