Cardiovascular DiseasesNCT00037258
Dyslipidemia and Risk of Cardiovascular Disease in Diabetic Men and Women
An observational study of Cardiovascular Diseases and Diabetes Mellitus, Non-insulin Dependent, run by Brigham and Women's Hospital.
Trial summary
To determine the role of dyslipidemia, markers of endothelial dysfunction genetic susceptibility, and dietary fat intake on the development of cardiovascular disease (CVD) complications in Type II diabetes mellitus. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Diabetes Mellitus, Non-insulin Dependent, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2001to Jul 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine the role of dyslipidemia, markers of endothelial dysfunction genetic susceptibility, and dietary fat intake on the development of cardiovascular disease (CVD) complications in Type II diabetes mellitus.
Read the detailed description
BACKGROUND:
The cardiovascular disease complications of Type II diabetes mellitus are a major public health problem. The research is designed to provide new information about the relation of specific biomarkers, genes, and diet on risk of CVD complications in the high-risk Type II diabetes mellitus population.
DESIGN NARRATIVE:
The study assesses biochemical markers of dyslipidemia and endothelial dysfunction, and omega-3 fatty acids in relation to risk of CVD among men and women diagnosed with type 2 diabetes in two large ongoing cohort studies, the Nurses Health Study (NHS) and Health Professionals Follow-up Study (HPFS). By 1998, 12,600 confirmed type 2 diabetic cases had already accumulated in the two cohorts. By the year 2002, 5,507 blood samples prospectively collected from persons with previously or newly diagnosed type 2 diabetes will be available for analyses. Using this unparalleled resource, the investigators will evaluate (1) The relationship between plasma levels of cell adhesion molecules (i.e. sICAM-1, sVCAM-1, E-selectin), diabetic dyslipidemia, and risk of CVD among diabetics; (2) the association between Lp(a) concentrations and risk of CVD among diabetics, independent of high triglycerides and low HDL; (3) the association between long-term intakes of omega-3 fatty acids and CVD risk in diabetes. The main NHS and HPFS grants will provide follow-up and documentation of CVD in addition to covariate information. Overall, the large size of these cohorts, the prospective design, the high follow-up rates, and the availability of archived blood specimens provide a unique opportunity to study the relationship between diabetic dyslipidemia and risk of CVD in an extremely cost-efficient and timely manner. In addition, these two cohorts provide an unusual opportunity to compare lipid profiles and endothelial markers of CVD between diabetic men and women.
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus, Non-insulin Dependent, Heart Diseases, Atherosclerosis, Diabetes Mellitus
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Heart Diseases, Atherosclerosis, Diabetes Mellitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2002 (estimated)
- Study startSep 2001
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Frank Hu, Brigham and Women's Hospital
- Investigators
- Frank Hu, Harvard University School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00037258
- Sponsor's protocol ID
- 1156
- Other IDs
- R01HL065582
- Status last verified
- Mar 2014
- First submitted
- 16 May 2002
- Last updated
- 1 Apr 2014
- Results posted
- No
Publications
Hu FB, Cho E, Rexrode KM, Albert CM, Manson JE. Fish and long-chain omega-3 fatty acid intake and risk of coronary heart disease and total mortality in diabetic women. Circulation. 2003 Apr 15;107(14):1852-7. doi: 10.1161/01.CIR.0000062644.42133.5F. Epub 2003 Mar 31.
PubMed 12668520Goldberger AL, Peng CK, Lipsitz LA. What is physiologic complexity and how does it change with aging and disease? Neurobiol Aging. 2002 Jan-Feb;23(1):23-6. doi: 10.1016/s0197-4580(01)00266-4. No abstract available.
PubMed 11755014Tanasescu M, Cho E, Manson JE, Hu FB. Dietary fat and cholesterol and the risk of cardiovascular disease among women with type 2 diabetes. Am J Clin Nutr. 2004 Jun;79(6):999-1005. doi: 10.1093/ajcn/79.6.999.
PubMed 15159229Shai I, Rimm EB, Schulze MB, Rifai N, Stampfer MJ, Hu FB. Moderate alcohol intake and markers of inflammation and endothelial dysfunction among diabetic men. Diabetologia. 2004 Oct;47(10):1760-7. doi: 10.1007/s00125-004-1526-0. Epub 2004 Oct 22.
PubMed 15502925Jiang R, Schulze MB, Li T, Rifai N, Stampfer MJ, Rimm EB, Hu FB. Non-HDL cholesterol and apolipoprotein B predict cardiovascular disease events among men with type 2 diabetes. Diabetes Care. 2004 Aug;27(8):1991-7. doi: 10.2337/diacare.27.8.1991.
PubMed 15277429Skinner HG, Michaud DS, Giovannucci EL, Rimm EB, Stampfer MJ, Willett WC, Colditz GA, Fuchs CS. A prospective study of folate intake and the risk of pancreatic cancer in men and women. Am J Epidemiol. 2004 Aug 1;160(3):248-58. doi: 10.1093/aje/kwh214.
PubMed 15257998Schulze MB, Rimm EB, Shai I, Rifai N, Hu FB. Relationship between adiponectin and glycemic control, blood lipids, and inflammatory markers in men with type 2 diabetes. Diabetes Care. 2004 Jul;27(7):1680-7. doi: 10.2337/diacare.27.7.1680.
PubMed 15220246Schulze MB, Rimm EB, Li T, Rifai N, Stampfer MJ, Hu FB. C-reactive protein and incident cardiovascular events among men with diabetes. Diabetes Care. 2004 Apr;27(4):889-94. doi: 10.2337/diacare.27.4.889.
PubMed 15047644Choi HK, Willett WC, Stampfer MJ, Rimm E, Hu FB. Dairy consumption and risk of type 2 diabetes mellitus in men: a prospective study. Arch Intern Med. 2005 May 9;165(9):997-1003. doi: 10.1001/archinte.165.9.997.
PubMed 15883237Qi L, Rimm E, Liu S, Rifai N, Hu FB. Dietary glycemic index, glycemic load, cereal fiber, and plasma adiponectin concentration in diabetic men. Diabetes Care. 2005 May;28(5):1022-8. doi: 10.2337/diacare.28.5.1022.
PubMed 15855561Wang Y, Rimm EB, Stampfer MJ, Willett WC, Hu FB. Comparison of abdominal adiposity and overall obesity in predicting risk of type 2 diabetes among men. Am J Clin Nutr. 2005 Mar;81(3):555-63. doi: 10.1093/ajcn/81.3.555.
PubMed 15755822Schulze MB, Shai I, Rimm EB, Li T, Rifai N, Hu FB. Adiponectin and future coronary heart disease events among men with type 2 diabetes. Diabetes. 2005 Feb;54(2):534-9. doi: 10.2337/diabetes.54.2.534.
PubMed 15677512
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyslipidemia and Risk of Cardiovascular Disease in Diabetic Men and Women
- ClinicalTrials.gov ID
- NCT00037258
- Acronym / sponsor ID
- 1156
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus, Non-insulin Dependent, Heart Diseases, Atherosclerosis, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2001
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 17 May 2002 (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.
To determine the role of dyslipidemia, markers of endothelial dysfunction genetic susceptibility, and dietary fat intake on the development of cardiovascular disease (CVD) complications in Type II diabetes mellitus.
Detailed description
BACKGROUND:
The cardiovascular disease complications of Type II diabetes mellitus are a major public health problem. The research is designed to provide new information about the relation of specific biomarkers, genes, and diet on risk of CVD complications in the high-risk Type II diabetes mellitus population.
DESIGN NARRATIVE:
The study assesses biochemical markers of dyslipidemia and endothelial dysfunction, and omega-3 fatty acids in relation to risk of CVD among men and women diagnosed with type 2 diabetes in two large ongoing cohort studies, the Nurses Health Study (NHS) and Health Professionals Follow-up Study (HPFS). By 1998, 12,600 confirmed type 2 diabetic cases had already accumulated in the two cohorts. By the year 2002, 5,507 blood samples prospectively collected from persons with previously or newly diagnosed type 2 diabetes will be available for analyses. Using this unparalleled resource, the investigators will evaluate (1) The relationship between plasma levels of cell adhesion molecules (i.e. sICAM-1, sVCAM-1, E-selectin), diabetic dyslipidemia, and risk of CVD among diabetics; (2) the association between Lp(a) concentrations and risk of CVD among diabetics, independent of high triglycerides and low HDL; (3) the association between long-term intakes of omega-3 fatty acids and CVD risk in diabetes. The main NHS and HPFS grants will provide follow-up and documentation of CVD in addition to covariate information. Overall, the large size of these cohorts, the prospective design, the high follow-up rates, and the availability of archived blood specimens provide a unique opportunity to study the relationship between diabetic dyslipidemia and risk of CVD in an extremely cost-efficient and timely manner. In addition, these two cohorts provide an unusual opportunity to compare lipid profiles and endothelial markers of CVD between diabetic men and women.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 1 Apr 2014.
- Background: PubMed 12668520Hu FB, Cho E, Rexrode KM, Albert CM, Manson JE. Fish and long-chain omega-3 fatty acid intake and risk of coronary heart disease and total mortality in diabetic women. Circulation. 2003 Apr 15;107(14):1852-7. doi: 10.1161/01.CIR.0000062644.42133.5F. Epub 2003 Mar 31.
- Background: PubMed 11755014Goldberger AL, Peng CK, Lipsitz LA. What is physiologic complexity and how does it change with aging and disease? Neurobiol Aging. 2002 Jan-Feb;23(1):23-6. doi: 10.1016/s0197-4580(01)00266-4. No abstract available.
- Background: PubMed 15159229Tanasescu M, Cho E, Manson JE, Hu FB. Dietary fat and cholesterol and the risk of cardiovascular disease among women with type 2 diabetes. Am J Clin Nutr. 2004 Jun;79(6):999-1005. doi: 10.1093/ajcn/79.6.999.
- Background: PubMed 15502925Shai I, Rimm EB, Schulze MB, Rifai N, Stampfer MJ, Hu FB. Moderate alcohol intake and markers of inflammation and endothelial dysfunction among diabetic men. Diabetologia. 2004 Oct;47(10):1760-7. doi: 10.1007/s00125-004-1526-0. Epub 2004 Oct 22.
- Background: PubMed 15277429Jiang R, Schulze MB, Li T, Rifai N, Stampfer MJ, Rimm EB, Hu FB. Non-HDL cholesterol and apolipoprotein B predict cardiovascular disease events among men with type 2 diabetes. Diabetes Care. 2004 Aug;27(8):1991-7. doi: 10.2337/diacare.27.8.1991.
- Background: PubMed 15257998Skinner HG, Michaud DS, Giovannucci EL, Rimm EB, Stampfer MJ, Willett WC, Colditz GA, Fuchs CS. A prospective study of folate intake and the risk of pancreatic cancer in men and women. Am J Epidemiol. 2004 Aug 1;160(3):248-58. doi: 10.1093/aje/kwh214.
- Background: PubMed 15220246Schulze MB, Rimm EB, Shai I, Rifai N, Hu FB. Relationship between adiponectin and glycemic control, blood lipids, and inflammatory markers in men with type 2 diabetes. Diabetes Care. 2004 Jul;27(7):1680-7. doi: 10.2337/diacare.27.7.1680.
- Background: PubMed 15047644Schulze MB, Rimm EB, Li T, Rifai N, Stampfer MJ, Hu FB. C-reactive protein and incident cardiovascular events among men with diabetes. Diabetes Care. 2004 Apr;27(4):889-94. doi: 10.2337/diacare.27.4.889.
- Background: PubMed 15883237Choi HK, Willett WC, Stampfer MJ, Rimm E, Hu FB. Dairy consumption and risk of type 2 diabetes mellitus in men: a prospective study. Arch Intern Med. 2005 May 9;165(9):997-1003. doi: 10.1001/archinte.165.9.997.
- Background: PubMed 15855561Qi L, Rimm E, Liu S, Rifai N, Hu FB. Dietary glycemic index, glycemic load, cereal fiber, and plasma adiponectin concentration in diabetic men. Diabetes Care. 2005 May;28(5):1022-8. doi: 10.2337/diacare.28.5.1022.
- Background: PubMed 15755822Wang Y, Rimm EB, Stampfer MJ, Willett WC, Hu FB. Comparison of abdominal adiposity and overall obesity in predicting risk of type 2 diabetes among men. Am J Clin Nutr. 2005 Mar;81(3):555-63. doi: 10.1093/ajcn/81.3.555.
- Background: PubMed 15677512Schulze MB, Shai I, Rimm EB, Li T, Rifai N, Hu FB. Adiponectin and future coronary heart disease events among men with type 2 diabetes. Diabetes. 2005 Feb;54(2):534-9. doi: 10.2337/diabetes.54.2.534.
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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.
Frank Hu
Harvard University School of Public Health
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Diabetes Mellitus, Non-insulin Dependent, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
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 NCT00037258, which also lists 12 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 1 Apr 2014.