- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00340509
A Genome-Wide Scan For Quantitative Trait Loci of Serum Bilirubin - A Framingham Study
December 13, 2019 updated by: National Heart, Lung, and Blood Institute (NHLBI)
Studies have shown that there is a significant association between serum bilirubin concentrations and risk of coronary artery disease (CAD).
So far, no linkage analysis in humans between serum bilirubin and DNA markers has been reported.
The purpose of this protocol is to identify chromosome regions that contain quantitative trait loci (QTL) involved in serum bilirubin metabolism and bilirubin concentration.
In the Framingham Study, a 10cM genome scan (about 400 markers) has been conducted in more than three hundred families.
Serum bilirubin was measured in the first and second exams of the Framingham Offspring.
These data provide us the opportunity to undertake linkage analyses to map QTL of serum bilirubin.
Study Overview
Status
Completed
Conditions
Detailed Description
Many studies showed that there is a significant relationship between serum bilirubin levels and risk of coronary artery disease (CAD).
We carried out a genome-wide scan for quantitative trait loci of serum bilirubin through the 330 extended Framingham families and found significant evidence of linkage of serum bilirubin to chromosome 2q telomere where an important candidate gene, Uridine diphosphate glycosyltransferase 1 gene (UGT1A1), resides.
The purposes of this protocol are to confirm linkage between serum bilirubin and UGT1A1, mathematical modeling and association studies between the genotypes of UGT1A1 and CAD.
Study Type
Observational
Enrollment (Actual)
1888
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Heart, Lung and Blood Institute (NHLBI), 9000 Rockville Pike
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- INCLUSION CRITERIA:
The study population will include the members of the 330 Framingham Study families and 1888 random individuals.
The Original Cohort will also be included.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gang PH Zheng, Ph.D., National Heart, Lung, and Blood Institute (NHLBI)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Djousse L, Levy D, Cupples LA, Evans JC, D'Agostino RB, Ellison RC. Total serum bilirubin and risk of cardiovascular disease in the Framingham offspring study. Am J Cardiol. 2001 May 15;87(10):1196-200; A4, 7. doi: 10.1016/s0002-9149(01)01494-1. No abstract available.
- Breimer LH, Wannamethee G, Ebrahim S, Shaper AG. Serum bilirubin and risk of ischemic heart disease in middle-aged British men. Clin Chem. 1995 Oct;41(10):1504-8.
- Almasy L, Blangero J. Multipoint quantitative-trait linkage analysis in general pedigrees. Am J Hum Genet. 1998 May;62(5):1198-211. doi: 10.1086/301844.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 26, 2001
Study Completion
July 23, 2013
Study Registration Dates
First Submitted
June 19, 2006
First Submitted That Met QC Criteria
June 19, 2006
First Posted (Estimate)
June 21, 2006
Study Record Updates
Last Update Posted (Actual)
December 16, 2019
Last Update Submitted That Met QC Criteria
December 13, 2019
Last Verified
July 23, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 999902016
- 02-H-N016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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