Cardiovascular DiseasesNCT00005236
Atherosclerosis and Omega-3 Fatty Acids in Alaskan Natives
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Atherosclerosis
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Dec 1988to Nov 1994
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the 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.
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Atherosclerosis, Coronary Artery Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startDec 1988
- Study completionNov 1994
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 National Heart, Lung, and Blood Institute (NHLBI)The 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
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005236
- Sponsor's protocol ID
- 1117
- Other IDs
- R01HL042082
- Status last verified
- Apr 2000
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
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.
PubMed 9341586Batzer 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.
PubMed 8576959Scheer 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.
PubMed 7605388Batzer 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.
PubMed 7991620Newman 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.
PubMed 8096960Mulvad 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.
PubMed 8871682Boudreau 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.
PubMed 8901165
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atherosclerosis and Omega-3 Fatty Acids in Alaskan Natives
- ClinicalTrials.gov ID
- NCT00005236
- Acronym / sponsor ID
- 1117
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Dec 1988
- Study completion
- Nov 1994 (actual)
- First posted
- 26 May 2000 (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 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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- 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 18 Feb 2016.
- Background: PubMed 9341586Newman 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.
- Background: PubMed 8576959Batzer 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.
- Background: PubMed 7605388Scheer 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.
- Background: PubMed 7991620Batzer 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.
- Background: PubMed 8096960Newman 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.
- Background: PubMed 8871682Mulvad 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.
- Background: PubMed 8901165Boudreau 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Feb 2016. 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 NCT00005236, which also lists 7 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 18 Feb 2016.