- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00287404
Measuring Cholesterol in the Fasting and Postmeal State in Patients With Type 2 Diabetes
19. december 2007 opdateret af: University of North Carolina
A Comparison of NMR and Chemical Lipid Analysis in the Fasting and Postprandial State in Patients With Type 2 Diabetes
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding
30
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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North Carolina
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Durham, North Carolina, Forenede Stater, 27713
- University of North Carolina Diabetes Care Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tidsperspektiver: Fremadrettet
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: John Buse, MD, PhD, University of North Carolina, Chapel Hill
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2005
Studieafslutning
1. september 2006
Datoer for studieregistrering
Først indsendt
3. februar 2006
Først indsendt, der opfyldte QC-kriterier
3. februar 2006
Først opslået (Skøn)
6. februar 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. december 2007
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. december 2007
Sidst verificeret
1. december 2007
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GCRC-2395
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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