Cardiovascular DiseasesNCT00005528
Genetics of CVD Risk Factors in Samoans
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To evaluate the role of known genes involved in lipid metabolism on serum lipid and apolipoprotein levels in Samoans residing in American and Western Samoa, who were exposed to the biobehavioral changes of modernization. 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, Obesity
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1995to Feb 2000
- 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 evaluate the role of known genes involved in lipid metabolism on serum lipid and apolipoprotein levels in Samoans residing in American and Western Samoa, who were exposed to the biobehavioral changes of modernization.
Read the detailed description
BACKGROUND:
Modernizing Samoans are characterized by high levels of certain cardiovascular disease (CVD) risk factors such as extreme adiposity and high prevalences of obesity and hypertension. However, lipid levels in Samoans such as total cholesterol and high density lipoprotein (HDL) cholesterol are not consistent with their obesity and not always consistent with ecological measures of modernization.
DESIGN NARRATIVE:
The cross-sectional study used serum lipid and lipoprotein and dietary data collected in 1994 and 1995 in American and Western Samoa to compare the American and Western Samoans. Quantitative determinations were made of lipid and apolipoprotein levels differences between the two groups. Estimates were made of the effects of dietary intake, body size, and smoking on lipid and apolipoproteins. Cross-sectional analyses were performed on genetic factors influencing lipid and lipoprotein levels. Statistical analyses were conducted to test hypotheses about gene-environment interactions and gene-gene interactions in polynesians from American Samoa and Western Samoa.
Diet, physical activity and body size vary with exposure to the influences of economic modernization and the adoption of non-traditional behaviors. Although adiposity and its central distribution, insulin, blood pressure and dietary cholesterol increase from Western Samoa to American Samoa, saturated fat intakes due to coconuts and cigarette smoking are greater in Western Samoa. Thus, modernization does not produce simple unilineal changes in risk factors. The investigators examined very specific hypotheses, based on the cross-sectional data collected in 1994 and 1995, about the influence of genes on lipids, about genetic interactions on lipids and about concrete environmental and specific gene interactions on lipid outcomes.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity, Atherosclerosis
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Obesity, Atherosclerosis
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 startApr 1995
- Study completionFeb 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Investigators
- Mohammad Kamboh, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005528
- Sponsor's protocol ID
- 5060
- Other IDs
- R01HL052611
- Status last verified
- Aug 2004
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Kamboh MI, McGarvey ST, Aston CE, Ferrell RE, Bausserman L. Plasma lipoprotein(a) distribution and its correlates among Samoans. Hum Biol. 2000 Apr;72(2):321-36.
PubMed 10803663Newman JD, McGarvey ST, Steele MS. Longitudinal association of cardiovascular reactivity and blood pressure in Samoan adolescents. Psychosom Med. 1999 Mar-Apr;61(2):243-9. doi: 10.1097/00006842-199903000-00017.
PubMed 10204978Galanis DJ, McGarvey ST, Quested C, Sio B, Afele-Fa'amuli SA. Dietary intake of modernizing Samoans: implications for risk of cardiovascular disease. J Am Diet Assoc. 1999 Feb;99(2):184-90. doi: 10.1016/s0002-8223(99)00044-9.
PubMed 9972185Steele MS, McGarvey ST. Anger expression, age, and blood pressure in modernizing Samoan adults. Psychosom Med. 1997 Nov-Dec;59(6):632-7. doi: 10.1097/00006842-199711000-00013.
PubMed 9407584Steele MS, McGarvey ST. Expression of anger by Samoan adults. Psychol Rep. 1996 Dec;79(3 Pt 2):1339-48. doi: 10.2466/pr0.1996.79.3f.1339.
PubMed 9009791DePrince K, McGarvey ST, McAllister AE, Bausserman L, Aston CE, Ferrell RE, Kamboh MI. Genetic effect of two APOA repeat polymorphisms (kringle 4 and pentanucleotide repeats) on plasma Lp(a) levels in American Samoans. Hum Biol. 2001 Feb;73(1):91-104. doi: 10.1353/hub.2001.0006.
PubMed 11332648Moffett S, Martinson J, Shriver MD, Deka R, McGarvey ST, Barrantes R, Ferrell RE. Genetic diversity and evolution of the human leptin locus tetranucleotide repeat. Hum Genet. 2002 May;110(5):412-7. doi: 10.1007/s00439-002-0715-5. Epub 2002 Apr 4.
PubMed 12073010McGarvey ST, Forrest W, Weeks DE, Sun G, Smelser D, Tufa J, Viali S, Deka R. Human leptin locus (LEP) alleles and BMI in Samoans. Int J Obes Relat Metab Disord. 2002 Jun;26(6):783-8. doi: 10.1038/sj.ijo.0801996.
PubMed 12037648Tsai HJ, Sun G, Weeks DE, Kaushal R, Wolujewicz M, McGarvey ST, Tufa J, Viali S, Deka R. Type 2 diabetes and three calpain-10 gene polymorphisms in Samoans: no evidence of association. Am J Hum Genet. 2001 Dec;69(6):1236-44. doi: 10.1086/324646. Epub 2001 Nov 5.
PubMed 11704924Choh AC, Gage TB, McGarvey ST, Comuzzie AG. Genetic and environmental correlations between various anthropometric and blood pressure traits among adult Samoans. Am J Phys Anthropol. 2001 Aug;115(4):304-11. doi: 10.1002/ajpa.1086.
PubMed 11471128
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of CVD Risk Factors in Samoans
- ClinicalTrials.gov ID
- NCT00005528
- Acronym / sponsor ID
- 5060
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 1995
- Study completion
- Feb 2000 (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 evaluate the role of known genes involved in lipid metabolism on serum lipid and apolipoprotein levels in Samoans residing in American and Western Samoa, who were exposed to the biobehavioral changes of modernization.
Detailed description
BACKGROUND:
Modernizing Samoans are characterized by high levels of certain cardiovascular disease (CVD) risk factors such as extreme adiposity and high prevalences of obesity and hypertension. However, lipid levels in Samoans such as total cholesterol and high density lipoprotein (HDL) cholesterol are not consistent with their obesity and not always consistent with ecological measures of modernization.
DESIGN NARRATIVE:
The cross-sectional study used serum lipid and lipoprotein and dietary data collected in 1994 and 1995 in American and Western Samoa to compare the American and Western Samoans. Quantitative determinations were made of lipid and apolipoprotein levels differences between the two groups. Estimates were made of the effects of dietary intake, body size, and smoking on lipid and apolipoproteins. Cross-sectional analyses were performed on genetic factors influencing lipid and lipoprotein levels. Statistical analyses were conducted to test hypotheses about gene-environment interactions and gene-gene interactions in polynesians from American Samoa and Western Samoa.
Diet, physical activity and body size vary with exposure to the influences of economic modernization and the adoption of non-traditional behaviors. Although adiposity and its central distribution, insulin, blood pressure and dietary cholesterol increase from Western Samoa to American Samoa, saturated fat intakes due to coconuts and cigarette smoking are greater in Western Samoa. Thus, modernization does not produce simple unilineal changes in risk factors. The investigators examined very specific hypotheses, based on the cross-sectional data collected in 1994 and 1995, about the influence of genes on lipids, about genetic interactions on lipids and about concrete environmental and specific gene interactions on lipid outcomes.
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 13 May 2016.
- Background: PubMed 10803663Kamboh MI, McGarvey ST, Aston CE, Ferrell RE, Bausserman L. Plasma lipoprotein(a) distribution and its correlates among Samoans. Hum Biol. 2000 Apr;72(2):321-36.
- Background: PubMed 10204978Newman JD, McGarvey ST, Steele MS. Longitudinal association of cardiovascular reactivity and blood pressure in Samoan adolescents. Psychosom Med. 1999 Mar-Apr;61(2):243-9. doi: 10.1097/00006842-199903000-00017.
- Background: PubMed 9972185Galanis DJ, McGarvey ST, Quested C, Sio B, Afele-Fa'amuli SA. Dietary intake of modernizing Samoans: implications for risk of cardiovascular disease. J Am Diet Assoc. 1999 Feb;99(2):184-90. doi: 10.1016/s0002-8223(99)00044-9.
- Background: PubMed 9407584Steele MS, McGarvey ST. Anger expression, age, and blood pressure in modernizing Samoan adults. Psychosom Med. 1997 Nov-Dec;59(6):632-7. doi: 10.1097/00006842-199711000-00013.
- Background: PubMed 9009791Steele MS, McGarvey ST. Expression of anger by Samoan adults. Psychol Rep. 1996 Dec;79(3 Pt 2):1339-48. doi: 10.2466/pr0.1996.79.3f.1339.
- Background: PubMed 11332648DePrince K, McGarvey ST, McAllister AE, Bausserman L, Aston CE, Ferrell RE, Kamboh MI. Genetic effect of two APOA repeat polymorphisms (kringle 4 and pentanucleotide repeats) on plasma Lp(a) levels in American Samoans. Hum Biol. 2001 Feb;73(1):91-104. doi: 10.1353/hub.2001.0006.
- Background: PubMed 12073010Moffett S, Martinson J, Shriver MD, Deka R, McGarvey ST, Barrantes R, Ferrell RE. Genetic diversity and evolution of the human leptin locus tetranucleotide repeat. Hum Genet. 2002 May;110(5):412-7. doi: 10.1007/s00439-002-0715-5. Epub 2002 Apr 4.
- Background: PubMed 12037648McGarvey ST, Forrest W, Weeks DE, Sun G, Smelser D, Tufa J, Viali S, Deka R. Human leptin locus (LEP) alleles and BMI in Samoans. Int J Obes Relat Metab Disord. 2002 Jun;26(6):783-8. doi: 10.1038/sj.ijo.0801996.
- Background: PubMed 11704924Tsai HJ, Sun G, Weeks DE, Kaushal R, Wolujewicz M, McGarvey ST, Tufa J, Viali S, Deka R. Type 2 diabetes and three calpain-10 gene polymorphisms in Samoans: no evidence of association. Am J Hum Genet. 2001 Dec;69(6):1236-44. doi: 10.1086/324646. Epub 2001 Nov 5.
- Background: PubMed 11471128Choh AC, Gage TB, McGarvey ST, Comuzzie AG. Genetic and environmental correlations between various anthropometric and blood pressure traits among adult Samoans. Am J Phys Anthropol. 2001 Aug;115(4):304-11. doi: 10.1002/ajpa.1086.
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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.
Mohammad Kamboh
University of Pittsburgh
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 13 May 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 NCT00005528, which also lists 10 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 13 May 2016.