Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT00287404
Status:
COMPLETED
Last Update Posted:
2007-12-28
First Post:
2006-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measuring Cholesterol in the Fasting and Postmeal State in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-09'}, 'lastUpdateSubmitDate': '2007-12-19', 'studyFirstSubmitDate': '2006-02-03', 'studyFirstSubmitQcDate': '2006-02-03', 'lastUpdatePostDateStruct': {'date': '2007-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-06', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['type 2 diabetes', 'hyperlipidemia', 'dyslipidemia', 'fasting lipids', 'postprandial lipids', 'Non-HDL cholesterol', 'NMR lipoanalysis', 'ATP III guidelines'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '14613352', 'type': 'BACKGROUND', 'citation': 'Bottorff MB. Underidentification and undertreatment issues. J Manag Care Pharm. 2003 Jan-Feb;9(1 Suppl):6-8. doi: 10.18553/jmcp.2003.9.s1.6.'}, {'pmid': '10886474', 'type': 'BACKGROUND', '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. doi: 10.1046/j.1525-1497.2000.03509.x.'}, {'pmid': '15249764', 'type': 'BACKGROUND', 'citation': 'Bittner V. Non-high-density lipoprotein cholesterol: an alternate target for lipid-lowering therapy. Prev Cardiol. 2004 Summer;7(3):122-6; quiz 129-30. doi: 10.1111/j.1520-037x.2004.3094.x.'}, {'pmid': '14647893', 'type': 'BACKGROUND', '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. doi: 10.1007/s00125-003-1269-3. Epub 2003 Nov 26.'}, {'pmid': '10977041', 'type': 'BACKGROUND', '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. doi: 10.2337/diacare.23.9.1401.'}, {'pmid': '12867223', 'type': 'BACKGROUND', '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. doi: 10.1016/s0149-2918(03)80134-0.'}, {'pmid': '12540621', 'type': 'BACKGROUND', '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. doi: 10.2337/diabetes.52.2.453.'}, {'pmid': '15142979', 'type': 'BACKGROUND', '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. doi: 10.1373/clinchem.2004.032938. Epub 2004 May 13.'}, {'pmid': '12485966', 'type': 'BACKGROUND', '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. No abstract available.'}, {'pmid': '17892636', 'type': 'DERIVED', 'citation': 'Dungan KM, Guster T, DeWalt DA, Buse JB. A comparison of lipid and lipoprotein measurements in the fasting and nonfasting states in patients with type 2 diabetes. Curr Med Res Opin. 2007 Nov;23(11):2689-95. doi: 10.1185/030079907x233304.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20-75\n* male or female\n* Type 2 diabetes\n* Hemoglobin A1C less than 9 at last measurement (within 3 months)\n\nExclusion Criteria:\n\n* Pregnancy\n* Non-English speaking.\n* Inability to fast for 12 hours\n* Hypoglycemia requiring assistance in the previous 6 months\n* Unwilling to consume the standardized meal'}, 'identificationModule': {'nctId': 'NCT00287404', 'briefTitle': 'Measuring Cholesterol in the Fasting and Postmeal State in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'A Comparison of NMR and Chemical Lipid Analysis in the Fasting and Postprandial State in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'GCRC-2395'}, 'secondaryIdInfos': [{'id': 'GCRC-2395'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27713', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Diabetes Care Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'John Buse, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'LipoScience, Inc.', 'class': 'INDUSTRY'}]}}}