Viewing Study NCT00287404



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Study NCT ID: NCT00287404
Status: COMPLETED
Last Update Posted: 2007-12-28
First Post: 2006-02-03

Brief Title: Measuring Cholesterol in the Fasting and Postmeal State in Patients With Type 2 Diabetes
Sponsor: University of North Carolina
Organization: University of North Carolina Chapel Hill

Study Overview

Official Title: A Comparison of NMR and Chemical Lipid Analysis in the Fasting and Postprandial State in Patients With Type 2 Diabetes
Status: COMPLETED
Status Verified Date: 2007-12
Last Known Status: None
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: Many patients with type 2 diabetes have difficulty attaining cholesterol goals partly due to the recommendations for fasting measurements that may not be practical in the typical clinical setting Focus toward therapy is shifting toward non-fasting assessments but little is known about the usefulness of this approach in diabetes where postmeal cholesterol levels are more abnormal This is an observational study examining fasting and postmeal lipids cholesterol in patients with type 2 diabetes using standard means and NMR
Detailed Description: Current treatment guidelines for dyslipidemia focus on fasting lipid panels specifically LDL cholesterol LDL but compliance has been shown to be poor Therefore focus has shifted to non-fasting measurements However there has been limited data in patients with type 2 diabetes and further study is needed to illuminate the lipid changes that occur in the non-fasting state This observational study examines fasting and postprandial lipids in patients with type 2 diabetes using standard chemical analysis and NMR For comparison lipid panels will be obtained at baseline and 3 hours following a standard meal in 30 patients with type 2 diabetes These measurements will then be analyzed based on current ATP III guidelines We will investigate the degree to which the postprandial assessments agree with the fasting assessments and the agreement between LDL and the two alternative measures --- non-HDL and NMR-LDL

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
Secondary IDs
Secondary ID Type Domain Link
GCRC-2395 None None None