Measuring Cholesterol in the Fasting and Postmeal State in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
LipoScience, Inc.
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00287404
First received: February 3, 2006
Last updated: December 19, 2007
Last verified: December 2007
  Purpose

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.


Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Comparison of NMR and Chemical Lipid Analysis in the Fasting and Postprandial State in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Estimated Enrollment: 30
Study Start Date: October 2005
Estimated Study Completion Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 20-75
  • male or female
  • Type 2 diabetes
  • Hemoglobin A1C less than 9 at last measurement (within 3 months)

Exclusion Criteria:

  • Pregnancy
  • Non-English speaking.
  • Inability to fast for 12 hours
  • Hypoglycemia requiring assistance in the previous 6 months
  • Unwilling to consume the standardized meal
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287404

Locations
United States, North Carolina
University of North Carolina Diabetes Care Center
Durham, North Carolina, United States, 27713
Sponsors and Collaborators
University of North Carolina
LipoScience, Inc.
Investigators
Principal Investigator: John Buse, MD, PhD University of North Carolina, Chapel Hill
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00287404     History of Changes
Other Study ID Numbers: GCRC-2395, GCRC-2395
Study First Received: February 3, 2006
Last Updated: December 19, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
type 2 diabetes
hyperlipidemia
dyslipidemia
fasting lipids
postprandial lipids
Non-HDL cholesterol
NMR lipoanalysis
ATP III guidelines

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014