Cardiovascular Risk FactorBPRHSNCT01231958
Boston Puerto Rican Health Study
An observational study of Cardiovascular Risk Factor, run by University of Massachusetts, Lowell at 3 sites in United States.
Trial summary
The investigators long-term goal is to understand the complex interactions of diet and other behavioral and environmental factors, genetics, and psychosocial stress on the high and apparently increasing prevalence of cardiovascular disease (CVD) risk factors in Puerto Rican adults. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- The Heart Healthy Initiative for Hispanic Adults (HIP)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,650 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2004to 30 Nov 2017
- 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Puerto Ricans older adults, aged 45-75 years, living in the Boston area.
Who may be able to join
- self-identified Puerto Rican decent
- aged 45-75 at baseline
- able to answer questions in English or Spanish
- living in the Boston, MA metropolitan area
Who cannot join
- unable to answer questions due to serious health conditions
- plan to move away from the area within two years
- Mini Mental State Examination (MMSE) score </=10
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tufts University
Boston, Massachusetts, 02111
Northeastern University
Boston, Massachusetts, 02115
University of Massachusetts Lowell
Lowell, Massachusetts, 01854
About this study
Official title: The Boston Puerto Rican Health Study: Center for Population Health and Health Disparities
The investigators long-term goal is to understand the complex interactions of diet and other behavioral and environmental factors, genetics, and psychosocial stress on the high and apparently increasing prevalence of cardiovascular disease (CVD) risk factors in Puerto Rican adults.
Read the detailed description
Puerto Rican adults living on the mainland US have documented health disparities; however, little research has been conducted with this second largest Hispanic subgroup. Our long-term goal is to understand the complex interactions of diet and other behavioral and environmental factors, genetics, and psychosocial stress on the high and apparently increasing prevalence of cardiovascular disease (CVD) risk factors in Puerto Rican adults. As this group is rapidly growing, understanding the reasons for this risk is of great importance. Our initial funding period for the Boston Puerto Rican Center for Population Health and Health Disparities (BPR-CPHHD, 2003-08) focused on the role of stress on physical disability and cognitive decline, through physiological dysregulation or "allostatic load." During that investigation, it became clear that risk factors for CVD were highly prevalent. These findings are in contrast to the commonly held belief that there is a Hispanic paradox--lower heart disease and mortality despite greater poverty. Importantly, the Puerto Rican population differs considerably in ancestral genetic history and in exposures to known risk factors from other Hispanic groups. They have unique dietary intake patterns, as well as social, cultural and environmental structures that contribute and affect reaction to stressors. During our initial funding period, we successfully assembled a cohort of 1500 Puerto Rican adults, aged 45-75 years at baseline, and completed two-year follow-up interviews on more than 1250 participants. As this population is aging and growing rapidly, the high prevalence and apparent cohort effect of increased heart disease risk factors suggest that 1) this population has serious health disparities in heart disease risk factors and 2) heart disease will become an even greater problem for this group in the near future. Our overall aim for this renewal is, therefore, to extend follow-up and to measure and analyze relevant characteristics and CVD risk factors, and to add additional contextual and outcome measures for CVD risk in this established cohort of Puerto Rican adults, so that we may better understand the dynamics of these disparities. Our model follows the transdisciplinary "cells to society" concept developed jointly with our partner CPHHDs during the initial funding period, with consideration of genetic variation in relation to longitudinal change in allostatic load and biochemical indicators of risk; with additional focus on social networks, neighborhood characteristics (physical space and access to food) and environment (air pollution) factors as social determinants of health. Finally, using community based participatory techniques, we will implement and test a multidimensional intervention that focuses on diet and exercise, but that also fully considers the social and physical environment to ensure success. With participation of our community partners, and the support of our administrative, biostatistics and laboratory cores, our team is efficiently poised to make significant contributions to understanding the factors that contribute to the apparent growing threat of heart disease in this highly disadvantaged group-while providing insights that may be useful to other vulnerable groups. The continuation of our cohort, with its rich constellation of measures, will allow us to unravel some of the complex etiologic interactions which contribute to CVD risk, so that effective interventions may be implemented. To date, we have completed approximately 840 5-year follow-up interviews.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- The Heart Healthy Initiative for Hispanic Adults (HIP)
- Keywords
- Puerto Rican; CVD; Hispanic; health disparities; allostatic load; diet
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Heart Healthy Initiative for Hispanic Adults (HIP)Behavioural
This randomized controlled pilot intervention study will include 150 Hispanic adults (45-75y) in the Greater Boston area. Participants will be randomized to either the intervention or control group after completing their baseline interview. The intervention group will receive 6 months of weekly group educational sessions, Zumba fitness classes and interactions with an embodied computer agent (ECA). The fitness classes and interactions with the ECA will continue for the second 6 months of the 1 year intervention. Intervention activities will occur at community centers in the greater Boston area. Control participants will receive standard of care for the first 6 months and will be offered the full intervention (weekly group educational sessions, Zumba fitness classes and interactions with the ECA) for the second 6 months of the study. Participants will complete an interview and blood draw at baseline, 6 months, and 12 months.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular disease risk
Measured: 5 years
Secondary outcomes (1)
10-year risk of Coronary Heart Disease (CHD)
10-year risk of CHD will be assessed using the Framingham Risk Score
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startJun 2004
- Primary completionOct 2009
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (108)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,650 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Lowell
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA), Tufts University, Northeastern University
- Responsible party
- Principal investigator, Katherine Tucker, University of Massachusetts, Lowell
- Investigators
- Katherine L. Tucker, PhD, Principal investigator, University of Massachusetts, Lowell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231958
- Sponsor's protocol ID
- P50HL105185
- Other IDs
- P01AG023394
- Acronym
- BPRHS
- Status last verified
- Mar 2020
- First submitted
- 4 Oct 2010
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Warnecke RB, Oh A, Breen N, Gehlert S, Paskett E, Tucker KL, Lurie N, Rebbeck T, Goodwin J, Flack J, Srinivasan S, Kerner J, Heurtin-Roberts S, Abeles R, Tyson FL, Patmios G, Hiatt RA. Approaching health disparities from a population perspective: the National Institutes of Health Centers for Population Health and Health Disparities. Am J Public Health. 2008 Sep;98(9):1608-15. doi: 10.2105/AJPH.2006.102525. Epub 2008 Jul 16.
PubMed 18633099Paskett ED, Reeves KW, McLaughlin JM, Katz ML, McAlearney AS, Ruffin MT, Halbert CH, Merete C, Davis F, Gehlert S. Recruitment of minority and underserved populations in the United States: the Centers for Population Health and Health Disparities experience. Contemp Clin Trials. 2008 Nov;29(6):847-61. doi: 10.1016/j.cct.2008.07.006. Epub 2008 Jul 31.
PubMed 18721901Orho-Melander M, Melander O, Guiducci C, Perez-Martinez P, Corella D, Roos C, Tewhey R, Rieder MJ, Hall J, Abecasis G, Tai ES, Welch C, Arnett DK, Lyssenko V, Lindholm E, Saxena R, de Bakker PI, Burtt N, Voight BF, Hirschhorn JN, Tucker KL, Hedner T, Tuomi T, Isomaa B, Eriksson KF, Taskinen MR, Wahlstrand B, Hughes TE, Parnell LD, Lai CQ, Berglund G, Peltonen L, Vartiainen E, Jousilahti P, Havulinna AS, Salomaa V, Nilsson P, Groop L, Altshuler D, Ordovas JM, Kathiresan S. Common missense variant in the glucokinase regulatory protein gene is associated with increased plasma triglyceride and C-reactive protein but lower fasting glucose concentrations. Diabetes. 2008 Nov;57(11):3112-21. doi: 10.2337/db08-0516. Epub 2008 Aug 4.
PubMed 18678614Tucker KL, Mattei J, Noel SE, Collado BM, Mendez J, Nelson J, Griffith J, Ordovas JM, Falcon LM. The Boston Puerto Rican Health Study, a longitudinal cohort study on health disparities in Puerto Rican adults: challenges and opportunities. BMC Public Health. 2010 Mar 1;10:107. doi: 10.1186/1471-2458-10-107.
PubMed 20193082Fullerton SM, Anderson EE, Cowan K, Malen RC, Brugge D. Awareness of Federal Regulatory Mechanisms Relevant to Community-Engaged Research: Survey of Health Disparities-Oriented NIH-Funded Investigators. J Empir Res Hum Res Ethics. 2015 Feb;10(1):13-21. doi: 10.1177/1556264614561964. Epub 2014 Dec 10.
PubMed 25742662Cooper LA, Ortega AN, Ammerman AS, Buchwald D, Paskett ED, Powell LH, Thompson B, Tucker KL, Warnecke RB, McCarthy WJ, Viswanath KV, Henderson JA, Calhoun EA, Williams DR. Calling for a bold new vision of health disparities intervention research. Am J Public Health. 2015 Jul;105 Suppl 3(Suppl 3):S374-6. doi: 10.2105/AJPH.2014.302386. Epub 2015 Apr 23. No abstract available.
PubMed 25905830Glik D, Sharif MZ, Tucker KL, Tejada SA, Prelip ML, Ammerman AS, Keyserling TC, Torres SE, Pitts SJ. Community engagement to support cardiovascular disease prevention in disparities populations: three case studies. J Health Dispar Res Pract Apr 2016;9:71-87.
Lai CQ, Tucker KL, Parnell LD, Adiconis X, Garcia-Bailo B, Griffith J, Meydani M, Ordovas JM. PPARGC1A variation associated with DNA damage, diabetes, and cardiovascular diseases: the Boston Puerto Rican Health Study. Diabetes. 2008 Apr;57(4):809-16. doi: 10.2337/db07-1238. Epub 2007 Dec 27.
PubMed 18162502Smith CE, Tucker KL, Yiannakouris N, Garcia-Bailo B, Mattei J, Lai CQ, Parnell LD, Ordovas JM. Perilipin polymorphism interacts with dietary carbohydrates to modulate anthropometric traits in hispanics of Caribbean origin. J Nutr. 2008 Oct;138(10):1852-8. doi: 10.1093/jn/138.10.1852.
PubMed 18806092DeVos L, Chanson A, Liu Z, Ciappio ED, Parnell LD, Mason JB, Tucker KL, Crott JW. Associations between single nucleotide polymorphisms in folate uptake and metabolizing genes with blood folate, homocysteine, and DNA uracil concentrations. Am J Clin Nutr. 2008 Oct;88(4):1149-58. doi: 10.1093/ajcn/88.4.1149.
PubMed 18842806Junyent M, Tucker KL, Smith CE, Garcia-Rios A, Mattei J, Lai CQ, Parnell LD, Ordovas JM. The effects of ABCG5/G8 polymorphisms on plasma HDL cholesterol concentrations depend on smoking habit in the Boston Puerto Rican Health Study. J Lipid Res. 2009 Mar;50(3):565-573. doi: 10.1194/jlr.P800041-JLR200. Epub 2008 Nov 12.
PubMed 19005228Perez-Martinez P, Corella D, Shen J, Arnett DK, Yiannakouris N, Tai ES, Orho-Melander M, Tucker KL, Tsai M, Straka RJ, Province M, Kai CS, Perez-Jimenez F, Lai CQ, Lopez-Miranda J, Guillen M, Parnell LD, Borecki I, Kathiresan S, Ordovas JM. Association between glucokinase regulatory protein (GCKR) and apolipoprotein A5 (APOA5) gene polymorphisms and triacylglycerol concentrations in fasting, postprandial, and fenofibrate-treated states. Am J Clin Nutr. 2009 Jan;89(1):391-9. doi: 10.3945/ajcn.2008.26363. Epub 2008 Dec 3.
PubMed 19056598Lai CQ, Tucker KL, Choudhry S, Parnell LD, Mattei J, Garcia-Bailo B, Beckman K, Burchard EG, Ordovas JM. Population admixture associated with disease prevalence in the Boston Puerto Rican health study. Hum Genet. 2009 Mar;125(2):199-209. doi: 10.1007/s00439-008-0612-7. Epub 2008 Dec 24.
PubMed 19107526Lai CQ, Parnell LD, Arnett DK, Garcia-Bailo B, Tsai MY, Kabagambe EK, Straka RJ, Province MA, An P, Borecki IB, Tucker KL, Ordovas JM. WDTC1, the ortholog of Drosophila adipose gene, associates with human obesity, modulated by MUFA intake. Obesity (Silver Spring). 2009 Mar;17(3):593-600. doi: 10.1038/oby.2008.561. Epub 2008 Dec 18.
PubMed 19238144Gao X, Scott T, Falcon LM, Wilde PE, Tucker KL. Food insecurity and cognitive function in Puerto Rican adults. Am J Clin Nutr. 2009 Apr;89(4):1197-203. doi: 10.3945/ajcn.2008.26941. Epub 2009 Feb 18.
PubMed 19225117
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Boston Puerto Rican Health Study: Center for Population Health and Health Disparities
- ClinicalTrials.gov ID
- NCT01231958
- Acronym / sponsor ID
- BPRHS / P50HL105185
- Conditions
- Cardiovascular Risk Factor
- Keywords
- Puerto Rican; CVD; Hispanic; health disparities; allostatic load; diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,650 participants (actual)
- Lead sponsor
- University of Massachusetts, LowellUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA), Tufts University, Northeastern University
- Study start
- Jun 2004
- Primary completion
- Oct 2009 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 1 Nov 2010 (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.
The investigators long-term goal is to understand the complex interactions of diet and other behavioral and environmental factors, genetics, and psychosocial stress on the high and apparently increasing prevalence of cardiovascular disease (CVD) risk factors in Puerto Rican adults.
Detailed description
Puerto Rican adults living on the mainland US have documented health disparities; however, little research has been conducted with this second largest Hispanic subgroup. Our long-term goal is to understand the complex interactions of diet and other behavioral and environmental factors, genetics, and psychosocial stress on the high and apparently increasing prevalence of cardiovascular disease (CVD) risk factors in Puerto Rican adults. As this group is rapidly growing, understanding the reasons for this risk is of great importance. Our initial funding period for the Boston Puerto Rican Center for Population Health and Health Disparities (BPR-CPHHD, 2003-08) focused on the role of stress on physical disability and cognitive decline, through physiological dysregulation or "allostatic load." During that investigation, it became clear that risk factors for CVD were highly prevalent. These findings are in contrast to the commonly held belief that there is a Hispanic paradox--lower heart disease and mortality despite greater poverty. Importantly, the Puerto Rican population differs considerably in ancestral genetic history and in exposures to known risk factors from other Hispanic groups. They have unique dietary intake patterns, as well as social, cultural and environmental structures that contribute and affect reaction to stressors. During our initial funding period, we successfully assembled a cohort of 1500 Puerto Rican adults, aged 45-75 years at baseline, and completed two-year follow-up interviews on more than 1250 participants. As this population is aging and growing rapidly, the high prevalence and apparent cohort effect of increased heart disease risk factors suggest that 1) this population has serious health disparities in heart disease risk factors and 2) heart disease will become an even greater problem for this group in the near future. Our overall aim for this renewal is, therefore, to extend follow-up and to measure and analyze relevant characteristics and CVD risk factors, and to add additional contextual and outcome measures for CVD risk in this established cohort of Puerto Rican adults, so that we may better understand the dynamics of these disparities. Our model follows the transdisciplinary "cells to society" concept developed jointly with our partner CPHHDs during the initial funding period, with consideration of genetic variation in relation to longitudinal change in allostatic load and biochemical indicators of risk; with additional focus on social networks, neighborhood characteristics (physical space and access to food) and environment (air pollution) factors as social determinants of health. Finally, using community based participatory techniques, we will implement and test a multidimensional intervention that focuses on diet and exercise, but that also fully considers the social and physical environment to ensure success. With participation of our community partners, and the support of our administrative, biostatistics and laboratory cores, our team is efficiently poised to make significant contributions to understanding the factors that contribute to the apparent growing threat of heart disease in this highly disadvantaged group-while providing insights that may be useful to other vulnerable groups. The continuation of our cohort, with its rich constellation of measures, will allow us to unravel some of the complex etiologic interactions which contribute to CVD risk, so that effective interventions may be implemented. To date, we have completed approximately 840 5-year follow-up interviews.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Puerto Ricans older adults, aged 45-75 years, living in the Boston area.
Key inclusion criteria (4 listed)
- self-identified Puerto Rican decent
- aged 45-75 at baseline
- able to answer questions in English or Spanish
- living in the Boston, MA metropolitan area
Key exclusion criteria (3 listed)
- unable to answer questions due to serious health conditions
- plan to move away from the area within two years
- Mini Mental State Examination (MMSE) score </=10
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Heart Healthy Initiative for Hispanic Adults (HIP)This randomized controlled pilot intervention study will include 150 Hispanic adults (45-75y) in the Greater Boston area. Participants will be randomized to either the intervention or control group after completing their baseline interview. The intervention group will receive 6 months of weekly group educational sessions, Zumba fitness classes and interactions with an embodied computer agent (ECA). The fitness classes and interactions with the ECA will continue for the second 6 months of the 1 year intervention. Intervention activities will occur at community centers in the greater Boston area. Control participants will receive standard of care for the first 6 months and will be offered the full intervention (weekly group educational sessions, Zumba fitness classes and interactions with the ECA) for the second 6 months of the study. Participants will complete an interview and blood draw at baseline, 6 months, and 12 months. | Behavioural | – |
Primary outcome
Cardiovascular disease risk
Time frame: 5 years
1 secondary outcome
10-year risk of Coronary Heart Disease (CHD)
Time frame: 5 years
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 25 Mar 2020.
- Background: PubMed 18633099Warnecke RB, Oh A, Breen N, Gehlert S, Paskett E, Tucker KL, Lurie N, Rebbeck T, Goodwin J, Flack J, Srinivasan S, Kerner J, Heurtin-Roberts S, Abeles R, Tyson FL, Patmios G, Hiatt RA. Approaching health disparities from a population perspective: the National Institutes of Health Centers for Population Health and Health Disparities. Am J Public Health. 2008 Sep;98(9):1608-15. doi: 10.2105/AJPH.2006.102525. Epub 2008 Jul 16.
- Background: PubMed 18721901Paskett ED, Reeves KW, McLaughlin JM, Katz ML, McAlearney AS, Ruffin MT, Halbert CH, Merete C, Davis F, Gehlert S. Recruitment of minority and underserved populations in the United States: the Centers for Population Health and Health Disparities experience. Contemp Clin Trials. 2008 Nov;29(6):847-61. doi: 10.1016/j.cct.2008.07.006. Epub 2008 Jul 31.
- Background: PubMed 18678614Orho-Melander M, Melander O, Guiducci C, Perez-Martinez P, Corella D, Roos C, Tewhey R, Rieder MJ, Hall J, Abecasis G, Tai ES, Welch C, Arnett DK, Lyssenko V, Lindholm E, Saxena R, de Bakker PI, Burtt N, Voight BF, Hirschhorn JN, Tucker KL, Hedner T, Tuomi T, Isomaa B, Eriksson KF, Taskinen MR, Wahlstrand B, Hughes TE, Parnell LD, Lai CQ, Berglund G, Peltonen L, Vartiainen E, Jousilahti P, Havulinna AS, Salomaa V, Nilsson P, Groop L, Altshuler D, Ordovas JM, Kathiresan S. Common missense variant in the glucokinase regulatory protein gene is associated with increased plasma triglyceride and C-reactive protein but lower fasting glucose concentrations. Diabetes. 2008 Nov;57(11):3112-21. doi: 10.2337/db08-0516. Epub 2008 Aug 4.
- Background: PubMed 20193082Tucker KL, Mattei J, Noel SE, Collado BM, Mendez J, Nelson J, Griffith J, Ordovas JM, Falcon LM. The Boston Puerto Rican Health Study, a longitudinal cohort study on health disparities in Puerto Rican adults: challenges and opportunities. BMC Public Health. 2010 Mar 1;10:107. doi: 10.1186/1471-2458-10-107.
- Background: PubMed 25742662Fullerton SM, Anderson EE, Cowan K, Malen RC, Brugge D. Awareness of Federal Regulatory Mechanisms Relevant to Community-Engaged Research: Survey of Health Disparities-Oriented NIH-Funded Investigators. J Empir Res Hum Res Ethics. 2015 Feb;10(1):13-21. doi: 10.1177/1556264614561964. Epub 2014 Dec 10.
- Background: PubMed 25905830Cooper LA, Ortega AN, Ammerman AS, Buchwald D, Paskett ED, Powell LH, Thompson B, Tucker KL, Warnecke RB, McCarthy WJ, Viswanath KV, Henderson JA, Calhoun EA, Williams DR. Calling for a bold new vision of health disparities intervention research. Am J Public Health. 2015 Jul;105 Suppl 3(Suppl 3):S374-6. doi: 10.2105/AJPH.2014.302386. Epub 2015 Apr 23. No abstract available.
- BackgroundGlik D, Sharif MZ, Tucker KL, Tejada SA, Prelip ML, Ammerman AS, Keyserling TC, Torres SE, Pitts SJ. Community engagement to support cardiovascular disease prevention in disparities populations: three case studies. J Health Dispar Res Pract Apr 2016;9:71-87.
- Results publication: PubMed 18162502Lai CQ, Tucker KL, Parnell LD, Adiconis X, Garcia-Bailo B, Griffith J, Meydani M, Ordovas JM. PPARGC1A variation associated with DNA damage, diabetes, and cardiovascular diseases: the Boston Puerto Rican Health Study. Diabetes. 2008 Apr;57(4):809-16. doi: 10.2337/db07-1238. Epub 2007 Dec 27.
- Results publication: PubMed 18806092Smith CE, Tucker KL, Yiannakouris N, Garcia-Bailo B, Mattei J, Lai CQ, Parnell LD, Ordovas JM. Perilipin polymorphism interacts with dietary carbohydrates to modulate anthropometric traits in hispanics of Caribbean origin. J Nutr. 2008 Oct;138(10):1852-8. doi: 10.1093/jn/138.10.1852.
- Results publication: PubMed 18842806DeVos L, Chanson A, Liu Z, Ciappio ED, Parnell LD, Mason JB, Tucker KL, Crott JW. Associations between single nucleotide polymorphisms in folate uptake and metabolizing genes with blood folate, homocysteine, and DNA uracil concentrations. Am J Clin Nutr. 2008 Oct;88(4):1149-58. doi: 10.1093/ajcn/88.4.1149.
- Results publication: PubMed 19005228Junyent M, Tucker KL, Smith CE, Garcia-Rios A, Mattei J, Lai CQ, Parnell LD, Ordovas JM. The effects of ABCG5/G8 polymorphisms on plasma HDL cholesterol concentrations depend on smoking habit in the Boston Puerto Rican Health Study. J Lipid Res. 2009 Mar;50(3):565-573. doi: 10.1194/jlr.P800041-JLR200. Epub 2008 Nov 12.
- Results publication: PubMed 19056598Perez-Martinez P, Corella D, Shen J, Arnett DK, Yiannakouris N, Tai ES, Orho-Melander M, Tucker KL, Tsai M, Straka RJ, Province M, Kai CS, Perez-Jimenez F, Lai CQ, Lopez-Miranda J, Guillen M, Parnell LD, Borecki I, Kathiresan S, Ordovas JM. Association between glucokinase regulatory protein (GCKR) and apolipoprotein A5 (APOA5) gene polymorphisms and triacylglycerol concentrations in fasting, postprandial, and fenofibrate-treated states. Am J Clin Nutr. 2009 Jan;89(1):391-9. doi: 10.3945/ajcn.2008.26363. Epub 2008 Dec 3.
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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.
Katherine L. Tucker, PhD principal investigator
University of Massachusetts, Lowell
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk Factor, run by University of Massachusetts, Lowell at 3 sites 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 3 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 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does the primary outcome measure?
Cardiovascular disease risk (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01231958, which also lists 108 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 25 Mar 2020; AzTrials last refreshed its copy on 26 Oct 2026.