Type 2 DiabetesNCT00287404
Measuring Cholesterol in the Fasting and Postmeal State in Patients With Type 2 Diabetes
An observational study of Type 2 Diabetes, run by University of North Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Sep 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-75
- male or female
- Type 2 diabetes
- Hemoglobin A1C less than 9 at last measurement (within 3 months)
Who cannot join
- Pregnancy
- Non-English speaking.
- Inability to fast for 12 hours
- Hypoglycemia requiring assistance in the previous 6 months
- Unwilling to consume the standardized meal
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Diabetes Care Center
Durham, North Carolina, 27713
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, hyperlipidemia, dyslipidemia, fasting lipids, postprandial lipids, Non-HDL cholesterol, NMR lipoanalysis, ATP III guidelines
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperlipidemias, Dyslipidemias
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startOct 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of North Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- LipoScience, Inc.
- Investigators
- John Buse, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287404
- Sponsor's protocol ID
- GCRC-2395
- Other IDs
- GCRC-2395
- Status last verified
- Dec 2007
- First submitted
- 3 Feb 2006
- Last updated
- 28 Dec 2007
- Results posted
- No
Publications
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.
PubMed 14613352Craig 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.
PubMed 10886474Bittner 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.
PubMed 15249764Iovine 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.
PubMed 14647893Teno 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.
PubMed 10977041Weiss 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.
PubMed 12867223Garvey 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.
PubMed 12540621Tsai 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.
PubMed 15142979National 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.
PubMed 12485966Dungan 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.
PubMed 17892636
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of NMR and Chemical Lipid Analysis in the Fasting and Postprandial State in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00287404
- Acronym / sponsor ID
- GCRC-2395
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, hyperlipidemia, dyslipidemia, fasting lipids, postprandial lipids, Non-HDL cholesterol, NMR lipoanalysis, ATP III guidelines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University of North CarolinaUniversity, hospital or other
- Collaborators
- LipoScience, Inc.
- Study start
- Oct 2005
- Study completion
- Sep 2006
- First posted
- 6 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20-75
- male or female
- Type 2 diabetes
- Hemoglobin A1C less than 9 at last measurement (within 3 months)
Key exclusion criteria (5 listed)
- Pregnancy
- Non-English speaking.
- Inability to fast for 12 hours
- Hypoglycemia requiring assistance in the previous 6 months
- Unwilling to consume the standardized meal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2007.
- Background: PubMed 14613352Bottorff 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.
- Background: PubMed 10886474Craig 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.
- Background: PubMed 15249764Bittner 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.
- Background: PubMed 14647893Iovine 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.
- Background: PubMed 10977041Teno 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.
- Background: PubMed 12867223Weiss 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.
- Background: PubMed 12540621Garvey 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.
- Background: PubMed 15142979Tsai 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.
- Background: PubMed 12485966National 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.
- Derived from this study: PubMed 17892636Dungan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Buse, MD, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by University of North Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00287404, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2007.