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

A Comparison of NMR and Chemical Lipid Analysis in the Fasting and Postprandial State in Patients With Type 2 Diabetes

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00287404

Enrollment

Registered

2006-02-06

Start date

2005-10-31

Completion date

2006-09-30

Last updated

2007-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes, hyperlipidemia, dyslipidemia, fasting lipids, postprandial lipids, Non-HDL cholesterol, NMR lipoanalysis, ATP III guidelines

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Countries

United States

Outcome results