Clinical trial NCT00287404: Measuring Cholesterol in the Fasting and Postmeal State in Patients With Type 2 Diabetes
Official title: A Comparison of NMR and Chemical Lipid Analysis in the Fasting and Postprandial State in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
hyperlipidemia
dyslipidemia
fasting lipids
postprandial lipids
Non-HDL cholesterol
NMR lipoanalysis
ATP III guidelines
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: LipoScience, Inc.
First posted: 2006-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: University of North Carolina Diabetes Care Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: John Buse, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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