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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00287404
First Posted: February 6, 2006
Last Update Posted: December 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
LipoScience, Inc.
Information provided by:
University of North Carolina, Chapel Hill
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

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
First Submitted: February 3, 2006
First Posted: February 6, 2006
Last Update Posted: December 28, 2007
Last Verified: December 2007

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