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Cardiovascular DiseasesNCT00005479

Diabetes, Lipoproteins and Accelerated Vascular Disease

An observational study of Cardiovascular Diseases and Heart Diseases, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To better understand the excess cardiovascular disease associated with diabetes mellitus. Read more about this study

Who is it for?
Ages 35 to 75 years
How many people
164 participants
Where
1 siteUnited States
Study dates
Sep 1996to Sep 2009
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 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Individuals with type 2 diabetes mellitus (DM) with or without coronary artery disease (CAD)

Who may be able to join

  • Patients with type 2 diabetes mellitus (DM), defined by medical record diagnosis, fasting glucose >140 mg/dl, or the use of diabetes medications
  • Had a myocardial infarction (MI) any time in the past, a coronary angiogram within the previous year, or an exercise perfusion scan (stress thallium study) within one year
  • Patients with CAD group, defined by the following criteria: documented prior MI, PTCA/stent, CABG, or >75% stenosis in any vessel by coronary angiography.
  • Patients without CAD group, defined as: the absence of a prior MI and <50% stenosis in all vessels by coronary angiography within the past year, or the combination of a normal exercise perfusion scan and the absence of a prior MI or any interventional cardiac procedures.

Who cannot join

  • MI or cardiac procedures within the past 3 months
  • Diagnoses of cancer, severe congestive heart failure (ejection fraction < 20%), kidney or liver disease, pancreatitis, other gastrointestinal conditions,
  • Laboratory values of creatinine levels > 1.3, abnormal liver function tests, abnormal CBC, fasting TG > 400 mg/dl, urine protein > 2+ on urinalysis or > 1000 mg/24 h, abnormal thyroid function tests, body mass index (BMI) > 34 for men and > 37 for women or BMI < 20 for both sexes
  • Age < 35 or > 75 years

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Columbia University

    New York, New York, 10032

Other trials in United States

About this study

Official title: Measures of Postprandial Lipoproteins Are Not Associated With Coronary Artery Disease in Patients With Type 2 Diabetes Mellitus

To better understand the excess cardiovascular disease associated with diabetes mellitus.

Read the detailed description

BACKGROUND:

Diabetes mellitus is associated with a 2-4 fold increase in risk for atherosclerotic cardiovascular disease. Atherosclerotic cardiovascular disease, particularly coronary artery disease, is the leading cause of death in diabetics. The study was a subproject within a program project grant, with Henry Ginsberg as principal investigator. The program project was part of an institute-initiated study on The Etiology of Excess Cardiovascular Disease in Diabetes Mellitus. The initiative originated after discussions between NHLBI and the Juvenile Diabetes Foundation International (JDFI). The Request for Applications (RFA) was originally issued in October 1994 and resulted in the award of one grant The RFA was reissued in December 1995 and resulted in the awarding of five program project grants, the one under discussion among them.

DESIGN NARRATIVE:

The study, subproject 3 within a program project grant, was entitled Atherogenic Triglyceride Rich Lipoproteins in Diabetes. The subproject examined the atherogenicity of hypertriglyceridemia in subjects with non-insulin dependent diabetes mellitus (NIDDM). Subproject 3 tested hypotheses concerning the impact of the size and number of triglyceride-rich lipoproteins (TGRL) on risk for atherosclerotic cardiovascular disease (ASCVD) in several human populations. A case-control study of diabetics with or without coronary artery disease determined if TGRL size and number differed between the groups. In this study, Whites, Blacks and Hispanics with documented coronary artery disease or with less than 50 percent coronary stenosis by angiography were recruited. The hypothesis was tested that increased apoB in small TGRL was associated with coronary artery disease. Fasting and postprandial blood samples were obtained for measurement of TGRL apoB level, TGRL TG:apoB ratio, the amount of apoB in apoE-rich TGRL, and retinyl palmitate clearance. Allelic differences in the apoB, apoE, LPL, and apoCIII genes were examined for effects on the size and number of TGRL: specific hypotheses were tested regarding the impact of these alleles.

TGRL size and number were also compared in diabetics with and without carotid atherosclerosis in the Atherosclerosis Risk in Communities (ARIC) study, in Sioux and Pima Indian tribes that differed in ASCVD rates, and in Blacks, Whites and Hispanics with a range of insulin levels and insulin resistance in the Insulin Resistance and Atherosclerosis Study (IRAS). These studies served both to confirm findings in the case-control study and to provide the opportunity to investigate diverse populations. The collaboration with IRAS allowed determination of the effects of insulin resistance and insulin secretory capacity on TGRL size and number. Finally, experiments with cultured endothelial cells were performed to determine if small TGRL could cause endothelial dysfunction. PMI-1 and VCAM-1 were markers of TGRL effects. In the case-control study, plasma PMI and VCAM-1 were measured to examine their relationship to coronary artery disease and to TGRL size and number.

Dollars awarded were estimated based on the CRISP assignment of $173,249 dollars in FY 1996 for Subproject 3. This was approximately 25 percent of the total dollars awarded and was used to estimated committed dollars.

Medical subject headings
Cardiovascular Diseases, Heart Diseases, Coronary Disease, Atherosclerosis, Carotid Artery Diseases, Diabetes Mellitus, Type 2, Diabetes Mellitus

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2000 (estimated)
  2. Study startSep 1996
  3. Primary completionAug 2001
  4. Study completionSep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005479
Sponsor's protocol ID
CUMC ID unknown (4963)
Other IDs
P01HL057217
Status last verified
Dec 2015
First submitted
25 May 2000
Last updated
28 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Heart Diseases, run by Columbia University 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 4 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 2015. 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?
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 2015.

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