Atherosclerosis and Omega-3 Fatty Acids in Alaskan Natives
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Atherosclerosis
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005236
First Posted
May 25, 2000
Last Updated
February 17, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005236
Brief Title
Atherosclerosis and Omega-3 Fatty Acids in Alaskan Natives
Study Type
Observational
2. Study Status
Record Verification Date
April 2000
Overall Recruitment Status
Completed
Study Start Date
December 1988 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 1994 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To determine whether there were differences in the prevalence and extent of atherosclerotic lesions in the coronaries and aortas between Alaskan natives and non-natives, and whether the extent of the lesions was related to omega-3 fatty acids in blood and tissues.
Detailed Description
BACKGROUND:
Purported low mortality from coronary heart disease in Eskimos from Greenland, Canada, or Alaska has been interpreted by many investigators as synonymous with the absence of or reduced amount of atherosclerotic lesions in the coronary arteries compared to populations with a high rate of coronary heart disease. It was thought that this study would help to clarify the role of omega-3 fatty acids in atherosclerosis but also would help in making a decision whether to recommend to the general public the inclusion of fish oils, which contain large amounts of these fatty acids in the diet, for prevention and/or reduction of atherosclerotic heart disease.
DESIGN NARRATIVE:
Coronary arteries, aortas, blood, adipose tissue, and liver were collected at autopsy from deceased Alaskan natives, aged 5 years and above, dying of all causes and from a similar number of age- and sex-matched non-native Alaskans. Tested standardized methods of gross evaluation, histomorphometry, and chemistry were used to characterize, measure, and evaluate the prevalence and extent of atherosclerosis in arteries. Chemical methods for determination of blood and tissue lipids and gas liquid chromatographic methods for determination of fatty acids in various lipid fractions in plasma and tissues were used. Risk factors for coronary artery disease were evaluated from tissues taken at autopsy. Hypertension was evaluated by an examination of kidney arterioles. Cigarette smoking was evaluated by measurement of thiocyanate in the blood and the presence or absence of diabetes was evaluated by measuring glycosylation of hemoglobin from red blood cells. Findings were compared with those studied in other populations such as Blacks and whites in New Orleans, and Japanese, Norwegians and nineteen other ethnic groups in the International Atherosclerosis Project.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Atherosclerosis, Coronary Arteriosclerosis
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
9341586
Citation
Newman WP 3rd, Middaugh JP, Guzman MA, Propst MT, Rogers DR. Comparison of atherosclerosis in alaska Natives and nonnatives. Arch Pathol Lab Med. 1997 Oct;121(10):1069-75.
Results Reference
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PubMed Identifier
8576959
Citation
Batzer MA, Arcot SS, Phinney JW, Alegria-Hartman M, Kass DH, Milligan SM, Kimpton C, Gill P, Hochmeister M, Ioannou PA, Herrera RJ, Boudreau DA, Scheer WD, Keats BJ, Deininger PL, Stoneking M. Genetic variation of recent Alu insertions in human populations. J Mol Evol. 1996 Jan;42(1):22-9. doi: 10.1007/BF00163207.
Results Reference
background
PubMed Identifier
7605388
Citation
Scheer WD, Boudreau DA, Malcom GT, Middaugh JP. Apolipoprotein E and atherosclerosis in Alaska Natives. Atherosclerosis. 1995 Apr 24;114(2):197-202. doi: 10.1016/0021-9150(94)05483-y.
Results Reference
background
PubMed Identifier
7991620
Citation
Batzer MA, Stoneking M, Alegria-Hartman M, Bazan H, Kass DH, Shaikh TH, Novick GE, Ioannou PA, Scheer WD, Herrera RJ, et al. African origin of human-specific polymorphic Alu insertions. Proc Natl Acad Sci U S A. 1994 Dec 6;91(25):12288-92. doi: 10.1073/pnas.91.25.12288.
Results Reference
background
PubMed Identifier
8096960
Citation
Newman WP, Middaugh JP, Propst MT, Rogers DR. Atherosclerosis in Alaska Natives and non-natives. Lancet. 1993 Apr 24;341(8852):1056-7. doi: 10.1016/0140-6736(93)92413-n.
Results Reference
background
PubMed Identifier
8871682
Citation
Mulvad G, Pedersen HS, Hansen JC, Dewailly E, Jul E, Pedersen M, Deguchi Y, Newman WP, Malcom GT, Tracy RE, Middaugh JP, Bjerregaard P. The Inuit diet. Fatty acids and antioxidants, their role in ischemic heart disease, and exposure to organochlorines and heavy metals. An international study. Arctic Med Res. 1996;55 Suppl 1:20-4.
Results Reference
background
PubMed Identifier
8901165
Citation
Boudreau DA, Middaugh JP, Mulvad G, Pedersen HS, Hansen JC, Malcom GT, Newman WP 3rd. Project meeting report: atherosclerosis & omega 3 fatty acids in Arctic Natives. Arctic Med Res. 1996 Jan;55(1):27-31. No abstract available.
Results Reference
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Atherosclerosis and Omega-3 Fatty Acids in Alaskan Natives
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