NCT00083369

Brief Summary

To characterize the genetic basis of the variable response of triglycerides to two environmental contexts, one that raises triglycerides (dietary fat), and one that lowers triglycerides (fenofibrate treatment.)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,327

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2002

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 24, 2004

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

6.7 years

First QC Date

May 21, 2004

Last Update Submit

November 16, 2013

Conditions

AtherosclerosisCardiovascular DiseasesHeart Diseases

Outcome Measures

Primary Outcomes (1)

  • describe the association between blood lipids and gene variants

    Blood lipids were measured by the following: triglyceride, high-density cholesterol, low-density cholesterol concentrations. We will describe the association between blood lipids and gene variants.

    3 weeks after start of fenofibrate intervention // 3 weeks after start of fenofibrate intervention

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects meeting entry criteria

You may qualify if:

  • ≥18 years of age
  • fasting TGs \<1,500 mg/dl
  • willingness to participate in the study and attend the scheduled clinic exams
  • member of a family with at least two members in a sibship
  • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) results within normal range
  • creatinine ≤2.0 mg/dl

You may not qualify if:

  • history of liver, kidney, pancreas, or gall bladder disease or malabsorption
  • current pregnancy
  • insulin use
  • use of lipid-lowering drugs (including prescription, over the counter, and nutriceuticals; volunteers taking these agents were withdrawn from them at least 4 weeks prior to the study with physician's approval)
  • use of warfarin
  • women of childbearing potential not using an acceptable form of contraception
  • known hyper-sensitivity to fenofibrate
  • history of pancreatitis within 12 months prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Slade E, Irvin MR, Xie K, Arnett DK, Claas SA, Kind T, Fardo DW, Graf GA. Age and sex are associated with the plasma lipidome: findings from the GOLDN study. Lipids Health Dis. 2021 Apr 3;20(1):30. doi: 10.1186/s12944-021-01456-2.

    PMID: 33812378DERIVED

  • Aslibekyan S, Almasy L, Province MA, Absher DM, Arnett DK. Data for GAW20: genome-wide DNA sequence variation and epigenome-wide DNA methylation before and after fenofibrate treatment in a family study of metabolic phenotypes. BMC Proc. 2018 Sep 17;12(Suppl 9):35. doi: 10.1186/s12919-018-0114-0. eCollection 2018.

    PMID: 30275886DERIVED

  • Blanco-Rojo R, Delgado-Lista J, Lee YC, Lai CQ, Perez-Martinez P, Rangel-Zuniga O, Smith CE, Hidalgo B, Alcala-Diaz JF, Gomez-Delgado F, Parnell LD, Arnett DK, Tucker KL, Lopez-Miranda J, Ordovas JM. Interaction of an S100A9 gene variant with saturated fat and carbohydrates to modulate insulin resistance in 3 populations of different ancestries. Am J Clin Nutr. 2016 Aug;104(2):508-17. doi: 10.3945/ajcn.116.130898. Epub 2016 Jul 20.

    PMID: 27440084DERIVED

  • Fretts AM, Follis JL, Nettleton JA, Lemaitre RN, Ngwa JS, Wojczynski MK, Kalafati IP, Varga TV, Frazier-Wood AC, Houston DK, Lahti J, Ericson U, van den Hooven EH, Mikkila V, Kiefte-de Jong JC, Mozaffarian D, Rice K, Renstrom F, North KE, McKeown NM, Feitosa MF, Kanoni S, Smith CE, Garcia ME, Tiainen AM, Sonestedt E, Manichaikul A, van Rooij FJ, Dimitriou M, Raitakari O, Pankow JS, Djousse L, Province MA, Hu FB, Lai CQ, Keller MF, Perala MM, Rotter JI, Hofman A, Graff M, Kahonen M, Mukamal K, Johansson I, Ordovas JM, Liu Y, Mannisto S, Uitterlinden AG, Deloukas P, Seppala I, Psaty BM, Cupples LA, Borecki IB, Franks PW, Arnett DK, Nalls MA, Eriksson JG, Orho-Melander M, Franco OH, Lehtimaki T, Dedoussis GV, Meigs JB, Siscovick DS. Consumption of meat is associated with higher fasting glucose and insulin concentrations regardless of glucose and insulin genetic risk scores: a meta-analysis of 50,345 Caucasians. Am J Clin Nutr. 2015 Nov;102(5):1266-78. doi: 10.3945/ajcn.114.101238. Epub 2015 Sep 9.

    PMID: 26354543DERIVED

  • Dashti HS, Aslibekyan S, Scheer FA, Smith CE, Lamon-Fava S, Jacques P, Lai CQ, Tucker KL, Arnett DK, Ordovas JM. Clock Genes Explain a Large Proportion of Phenotypic Variance in Systolic Blood Pressure and This Control Is Not Modified by Environmental Temperature. Am J Hypertens. 2016 Jan;29(1):132-40. doi: 10.1093/ajh/hpv082. Epub 2015 Jun 4.

    PMID: 26045533DERIVED

  • Tanaka T, Ngwa JS, van Rooij FJ, Zillikens MC, Wojczynski MK, Frazier-Wood AC, Houston DK, Kanoni S, Lemaitre RN, Luan J, Mikkila V, Renstrom F, Sonestedt E, Zhao JH, Chu AY, Qi L, Chasman DI, de Oliveira Otto MC, Dhurandhar EJ, Feitosa MF, Johansson I, Khaw KT, Lohman KK, Manichaikul A, McKeown NM, Mozaffarian D, Singleton A, Stirrups K, Viikari J, Ye Z, Bandinelli S, Barroso I, Deloukas P, Forouhi NG, Hofman A, Liu Y, Lyytikainen LP, North KE, Dimitriou M, Hallmans G, Kahonen M, Langenberg C, Ordovas JM, Uitterlinden AG, Hu FB, Kalafati IP, Raitakari O, Franco OH, Johnson A, Emilsson V, Schrack JA, Semba RD, Siscovick DS, Arnett DK, Borecki IB, Franks PW, Kritchevsky SB, Lehtimaki T, Loos RJ, Orho-Melander M, Rotter JI, Wareham NJ, Witteman JC, Ferrucci L, Dedoussis G, Cupples LA, Nettleton JA. Genome-wide meta-analysis of observational studies shows common genetic variants associated with macronutrient intake. Am J Clin Nutr. 2013 Jun;97(6):1395-402. doi: 10.3945/ajcn.112.052183. Epub 2013 May 1.

    PMID: 23636237DERIVED

  • Frazier-Wood AC, Kabagambe EK, Wojczynski MK, Borecki IB, Tiwari HK, Smith CE, Ordovas JM, Arnett DK. The association between LRP-1 variants and chylomicron uptake after a high fat meal. Nutr Metab Cardiovasc Dis. 2013 Nov;23(11):1154-8. doi: 10.1016/j.numecd.2012.12.007. Epub 2013 Feb 26.

    PMID: 23484911DERIVED

MeSH Terms

Conditions

AtherosclerosisCardiovascular DiseasesHeart Diseases

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Donna Arnett

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2004

First Posted

May 24, 2004

Study Start

September 1, 2002

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

November 19, 2013

Record last verified: 2013-11