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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287404
• Other study ID #: GCRC-2395
• Secondary ID: GCRC-2395
• Status: Completed
• Phase: N/A
• First received: February 3, 2006
• Last updated: December 19, 2007
• Start date: October 2005
• Est. completion date: September 2006

Study information

• Verified date: December 2007
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	University of North Carolina Diabetes Care Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina	LipoScience, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (9)

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Bottorff MB. Underidentification and undertreatment issues. J Manag Care Pharm. 2003 Jan-Feb;9(1 Suppl):6-8. — View Citation

Craig SR, Amin RV, Russell DW, Paradise NF. Blood cholesterol screening influence of fasting state on cholesterol results and management decisions. J Gen Intern Med. 2000 Jun;15(6):395-9. — View Citation

Garvey WT, Kwon S, Zheng D, Shaughnessy S, Wallace P, Hutto A, Pugh K, Jenkins AJ, Klein RL, Liao Y. Effects of insulin resistance and type 2 diabetes on lipoprotein subclass particle size and concentration determined by nuclear magnetic resonance. Diabetes. 2003 Feb;52(2):453-62. — View Citation

Iovine C, Vaccaro O, Gentile A, Romano G, Pisanti F, Riccardi G, Rivellese AA. Post-prandial triglyceride profile in a population-based sample of Type 2 diabetic patients. Diabetologia. 2004 Jan;47(1):19-22. Epub 2003 Nov 26. — View Citation

National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. — View Citation

Teno S, Uto Y, Nagashima H, Endoh Y, Iwamoto Y, Omori Y, Takizawa T. Association of postprandial hypertriglyceridemia and carotid intima-media thickness in patients with type 2 diabetes. Diabetes Care. 2000 Sep;23(9):1401-6. — View Citation

Tsai MY, Georgopoulos A, Otvos JD, Ordovas JM, Hanson NQ, Peacock JM, Arnett DK. Comparison of ultracentrifugation and nuclear magnetic resonance spectroscopy in the quantification of triglyceride-rich lipoproteins after an oral fat load. Clin Chem. 2004 Jul;50(7):1201-4. Epub 2004 May 13. — View Citation

Weiss R, Harder M, Rowe J. The relationship between nonfasting and fasting lipid measurements in patients with or without type 2 diabetes mellitus receiving treatment with 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors. Clin Ther. 2003 May;25(5):1490-7. — View Citation