ID

45617

Beschrijving

Principal Investigator: Donna Arnett, PhD, College of Public Health, University of Kentucky, Lexington, KY, USA MeSH: Lipids,Cardiovascular Diseases,Acute-Phase Proteins,Glucose Metabolism Disorders,Blood Pressure,Body Mass Index,Adiponectin https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001359 The GOLDN study was initiated to assess how genetic factors interact with environmental (diet and drug) interventions to influence blood levels of triglycerides and other atherogenic lipid species and inflammation markers (registered at clinicaltrials.gov, number NCT00083369). The study recruited Caucasian participants primarily from three-generational pedigrees from two NHLBI Family Heart Study (FHS) field centers (Minneapolis, MN and Salt Lake City, UT). Only families with at least two siblings were recruited and only participants who did not take lipid-lowering agents (pharmaceuticals or nutraceuticals) for at least 4 weeks prior to the initial visit were included. The diet intervention followed the protocol of Patsch et al. (1992). The whipping cream (83% fat) meal had 700 Calories/m2 body surface area (2.93 mJ/m2 body surface area): 3% of calories were derived from protein (instant nonfat dry milk) and 14% from carbohydrate (sugar). The ratio of polyunsaturated to saturated fat was 0.06 and the cholesterol content of the average meal was 240 mg. The mixture was blended with ice and flavorings. Blood samples were drawn immediately before (fasting) and at 3.5 and 6 hours after consuming the high-fat meal. The diet intervention was administered at baseline as well as after a 3-week treatment with 160 mg micronized fenofibrate. Participants were given the option to complete one or both (diet and drug) interventions. Of all participants, 1079 had phenotypic data and provided appropriate consent, and underwent whole genome sequencing through the Trans-Omics for Precision Medicine (TOPMed) program. Comprehensive phenotypic and pedigree data for GOLDN study participants are available through dbGaP phs000741.

Link

dbGaP study = phs001359

Trefwoorden

Versies (1)
  1. 26-02-23 26-02-23 - Simon Heim
Houder van rechten

Donna Arnett, PhD, College of Public Health, University of Kentucky, Lexington, KY, USA

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26 februari 2023

DOI

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Licentie

Creative Commons BY 4.0
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dbGaP phs001359 NHLBI TOPMed: GOLDN Epigenetic Determinants of Lipid Response to Dietary Fat and Fenofibrate

Engels

Eligibility Criteria

4 Formulieren  
Inclusion and exclusion criteria
Beschrijving

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
To participate in the GOLDN study, participants were required to be identified through families previously screened in the NHLBI FHS Minnesota or Utah centers. Because FHS was conducted exclusively in participants of Caucasian descent, the GOLDN population is entirely white, and this was scientifically acceptable when originally funded because (a) the source cohort was all of Caucasian descent and (b) PROGENI as a program had representation from other ethnic groups. For GOLDN, eligible family members were 18 years of age or older, had fasting triglycerides < 1500 mg/dL, were in a family with at least two members in a sibship, had normal liver function tests (i.e., aspartate transaminase and alanine transaminase tests within normal range), and creatinine values ≤ 2.0. Anyone with a history of liver, kidney, pancreas, gall bladder disease or malabsorption was excluded, as were pregnant women or women of childbearing potential not using an acceptable form of contraception, or anyone requiring insulin to treat diabetes. Individuals using hypolipidemic drugs were asked to consult with their physician and were taken off medications at least four weeks prior to the study after informed consent for drug withdrawal was obtained. Participants in the current study provided written informed consent to DNA sharing options that allowed future research to be conducted from stored specimens.
Beschrijving

To participate in the GOLDN study, participants were required to be identified through families previously screened in the NHLBI FHS Minnesota or Utah centers. Because FHS was conducted exclusively in participants of Caucasian descent, the GOLDN population is entirely white, and this was scientifically acceptable when originally funded because (a) the source cohort was all of Caucasian descent and (b) PROGENI as a program had representation from other ethnic groups. For GOLDN, eligible family members were 18 years of age or older, had fasting triglycerides < 1500 mg/dL, were in a family with at least two members in a sibship, had normal liver function tests (i.e., aspartate transaminase and alanine transaminase tests within normal range), and creatinine values ≤ 2.0. Anyone with a history of liver, kidney, pancreas, gall bladder disease or malabsorption was excluded, as were pregnant women or women of childbearing potential not using an acceptable form of contraception, or anyone requiring insulin to treat diabetes. Individuals using hypolipidemic drugs were asked to consult with their physician and were taken off medications at least four weeks prior to the study after informed consent for drug withdrawal was obtained. Participants in the current study provided written informed consent to DNA sharing options that allowed future research to be conducted from stored specimens.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0947630
UMLS CUI [1,2]
C0679646
UMLS CUI [1,3]
C0205396
UMLS CUI [1,4]
C2064690
UMLS CUI [1,5]
C1955970
UMLS CUI [1,6]
C0026183
UMLS CUI [1,7]
C0042124
UMLS CUI [1,8]
C4704895
UMLS CUI [1,9]
C0679646
UMLS CUI [1,10]
C0007457
UMLS CUI [1,11]
C1879533
UMLS CUI [1,12]
C5441552
UMLS CUI [1,13]
C0086282
UMLS CUI [1,14]
C0001779
UMLS CUI [1,15]
C2874288
UMLS CUI [1,16]
C0438235
UMLS CUI [1,17]
C0004002
UMLS CUI [1,18]
C0001899
UMLS CUI [1,19]
C0010294
UMLS CUI [1,20]
C0455550
UMLS CUI [1,21]
C0455686
UMLS CUI [1,22]
C0558976
UMLS CUI [1,23]
C0683519
UMLS CUI [1,24]
C0030286
UMLS CUI [1,25]
C3714745
UMLS CUI [1,26]
C0033011
UMLS CUI [1,27]
C4324275
UMLS CUI [1,28]
C0680251
UMLS CUI [1,29]
C2919192
UMLS CUI [1,30]
C4227726
UMLS CUI [1,31]
C0086440
UMLS CUI [1,32]
C0548440
UMLS CUI [1,33]
C5421123
UMLS CUI [1,34]
C0021430
UMLS CUI [1,35]
C1546942
UMLS CUI [1,36]
C0012854
UMLS CUI [1,37]
C0035168
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Similar models

Eligibility Criteria

4 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
To participate in the GOLDN study, participants were required to be identified through families previously screened in the NHLBI FHS Minnesota or Utah centers. Because FHS was conducted exclusively in participants of Caucasian descent, the GOLDN population is entirely white, and this was scientifically acceptable when originally funded because (a) the source cohort was all of Caucasian descent and (b) PROGENI as a program had representation from other ethnic groups. For GOLDN, eligible family members were 18 years of age or older, had fasting triglycerides < 1500 mg/dL, were in a family with at least two members in a sibship, had normal liver function tests (i.e., aspartate transaminase and alanine transaminase tests within normal range), and creatinine values ≤ 2.0. Anyone with a history of liver, kidney, pancreas, gall bladder disease or malabsorption was excluded, as were pregnant women or women of childbearing potential not using an acceptable form of contraception, or anyone requiring insulin to treat diabetes. Individuals using hypolipidemic drugs were asked to consult with their physician and were taken off medications at least four weeks prior to the study after informed consent for drug withdrawal was obtained. Participants in the current study provided written informed consent to DNA sharing options that allowed future research to be conducted from stored specimens.
Item
To participate in the GOLDN study, participants were required to be identified through families previously screened in the NHLBI FHS Minnesota or Utah centers. Because FHS was conducted exclusively in participants of Caucasian descent, the GOLDN population is entirely white, and this was scientifically acceptable when originally funded because (a) the source cohort was all of Caucasian descent and (b) PROGENI as a program had representation from other ethnic groups. For GOLDN, eligible family members were 18 years of age or older, had fasting triglycerides < 1500 mg/dL, were in a family with at least two members in a sibship, had normal liver function tests (i.e., aspartate transaminase and alanine transaminase tests within normal range), and creatinine values ≤ 2.0. Anyone with a history of liver, kidney, pancreas, gall bladder disease or malabsorption was excluded, as were pregnant women or women of childbearing potential not using an acceptable form of contraception, or anyone requiring insulin to treat diabetes. Individuals using hypolipidemic drugs were asked to consult with their physician and were taken off medications at least four weeks prior to the study after informed consent for drug withdrawal was obtained. Participants in the current study provided written informed consent to DNA sharing options that allowed future research to be conducted from stored specimens.
boolean
C0947630 (UMLS CUI [1,1])
C0679646 (UMLS CUI [1,2])
C0205396 (UMLS CUI [1,3])
C2064690 (UMLS CUI [1,4])
C1955970 (UMLS CUI [1,5])
C0026183 (UMLS CUI [1,6])
C0042124 (UMLS CUI [1,7])
C4704895 (UMLS CUI [1,8])
C0679646 (UMLS CUI [1,9])
C0007457 (UMLS CUI [1,10])
C1879533 (UMLS CUI [1,11])
C5441552 (UMLS CUI [1,12])
C0086282 (UMLS CUI [1,13])
C0001779 (UMLS CUI [1,14])
C2874288 (UMLS CUI [1,15])
C0438235 (UMLS CUI [1,16])
C0004002 (UMLS CUI [1,17])
C0001899 (UMLS CUI [1,18])
C0010294 (UMLS CUI [1,19])
C0455550 (UMLS CUI [1,20])
C0455686 (UMLS CUI [1,21])
C0558976 (UMLS CUI [1,22])
C0683519 (UMLS CUI [1,23])
C0030286 (UMLS CUI [1,24])
C3714745 (UMLS CUI [1,25])
C0033011 (UMLS CUI [1,26])
C4324275 (UMLS CUI [1,27])
C0680251 (UMLS CUI [1,28])
C2919192 (UMLS CUI [1,29])
C4227726 (UMLS CUI [1,30])
C0086440 (UMLS CUI [1,31])
C0548440 (UMLS CUI [1,32])
C5421123 (UMLS CUI [1,33])
C0021430 (UMLS CUI [1,34])
C1546942 (UMLS CUI [1,35])
C0012854 (UMLS CUI [1,36])
C0035168 (UMLS CUI [1,37])
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