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dbGaP phs001359 NHLBI TOPMed: GOLDN Epigenetic Determinants of Lipid Response to Dietary Fat and Fenofibrate - pht008688.v1.p1

- 2023-02-26 - 4 Formulär, 1 Item-grupp, 6 Dataelement, 1 Språk
Item-grupp: pht008688
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.

pht008689.v1.p1

1 Item-grupp 2 Dataelement

pht008690.v1.p1

1 Item-grupp 9 Dataelement

Eligibility

1 Item-grupp 1 Dataelement

dbGaP phs001215 NHLBI TOPMed: San Antonio Family Heart Study (SAFHS) - Eligibility

- 2023-05-16 - 6 Formulär, 1 Item-grupp, 4 Dataelement, 1 Språk
Item-grupp: IG.elig
Principal Investigator: John Blangero, PhD, University of Texas Rio Grande Valley, Brownsville, TX, USA MeSH: Cardiovascular Diseases,Body Height,Body Weight,Body Mass Index,Waist Circumference,Blood Glucose,Insulin,Diabetes Mellitus, Type 2,Blood Pressure,Cholesterol,Cholesterol, HDL,Triglycerides https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001215 The San Antonio Family Heart Study (SAFHS) is a complex pedigree-based mixed longitudinal study designed to identify low frequency or rare variants influencing susceptibility to cardiovascular disease, using whole genome sequence (WGS) information from 2,590 individuals in large Mexican American pedigrees from San Antonio, Texas. The major objectives of this study are to identify low frequency or rare variants in and around known common variant signals for CVD, as well as to find novel low frequency or rare variants influencing susceptibility to CVD. WGS of the SAFHS cohort has been obtained through three efforts. Approximately 540 WGS were performed commercially at 50X by Complete Genomics, Inc (CGI) as part of the large T2D-GENES Project. The phenotype and genotype data for this group is available at dbGaP under accession number phs000462. An additional ~900 WGS at 30X were obtained through Illumina as part of the R01HL113322 "Whole Genome Sequencing to Identify Causal Genetic Variants Influencing CVD Risk" project. Finally, ~1,150 WGS at 30X WGS were obtained through Illumina funded by a supplement as part of the NHLBI's TOPMed program. Extensive phenotype data are provided for sequenced individuals primarily obtained from the P01HL45522 "Genetics of Atherosclerosis in Mexican Americans" for adults and R01HD049051 for children in these same families. Phenotype information was collected between 1991 and 2016. For this dataset, the SAFHS appellation represents an amalgamation of the original SAFHS participants and an expansion that reexamined families previously recruited for the San Antonio Family Diabetes Study (R01DK042273) and the San Antonio Family Gall Bladder Study (R01DK053889). Due to this substantial examination history, participants may have information from up to five visits. The clinical variables reported are coordinated with TOPMed and include major adverse cardiac events (MACE), T2D status and age at diagnosis, glycemic traits (fasting glucose and insulin), blood pressure, blood lipids (total cholesterol, HDL cholesterol, calculated LDL cholesterol and triglycerides). Additional phenotype data include the medication status at each visit, classified in four categories as any current use of diabetes, hypertension or lipid-lowering medications, and, for females, current use of female hormones. Anthropometric measurements include age, sex, height, weight, hip circumference, waist circumference and derived ratios. PBMC derived gene expression assays for a subset of ~1,060 individuals obtained using the Illumina Sentrix-6 chip is also available from the baseline examination. The WGS data have been jointly called and are available in the current TOPMed accession (phs001215).

pht008628.v2.p2

1 Item-grupp 4 Dataelement

pht008629.v2.p2

1 Item-grupp 6 Dataelement

pht008631.v2.p2

1 Item-grupp 24 Dataelement

pht008632.v2.p2

1 Item-grupp 10 Dataelement

pht008630.v2.p2

1 Item-grupp 2 Dataelement

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 1 Day 13 (Visit 110): Pharmacodynamics, Vital Signs, Drug Administration

- 2018-12-21 - 1 Formulär, 4 Item-grupper, 28 Dataelement, 1 Språk
Item-grupper: Administrative data, Study Drug Administration, Vital Signs, Pharmacodynamic Blood Collection
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Screening Visit: Vital Signs Form

- 2018-11-14 - 1 Formulär, 2 Item-grupper, 20 Dataelement, 1 Språk
Item-grupper: Administrative data, Vital Signs
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Unscheduled Visit: Vital Signs, Physical Examination,

- 2018-12-28 - 1 Formulär, 14 Item-grupper, 69 Dataelement, 1 Språk
Item-grupper: Administrative data, Vital Signs, Blood Pressure, Heart Rate, Respiratory Rate, Temperature, Physical Examination, Assessment, Electrocardiogram, ECG Details, Overall Interpretation of ECG, Central Laboratory Tests, Blood, Urine
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 1 Day 22+26 (Visit 160-170): Vital Signs, Drug Administration, ECG, Laboratory Tests

- 2018-12-24 - 1 Formulär, 11 Item-grupper, 57 Dataelement, 1 Språk
Item-grupper: Administrative data, Vital Signs, Duplicate 1, Duplicate 2, Study Drug Administration, Pharmacokinetic Blood Collection, Period 1 - Day 26, Vital Signs, Duplicate 1, Duplicate 2, Study Drug Administration
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 1 Day 11 (Visit 90): Vital Signs, Pharmacogenetics, Pharmacodynamics, Drug Admission

- 2018-12-21 - 1 Formulär, 6 Item-grupper, 36 Dataelement, 1 Språk
Item-grupper: Administrative data, Admission Criteria, Study Drug Administration, Pharmacogenetic Blood Collection, Vital Signs, Pharmacodynamic Blood Collection
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 2 Day 21 + Day 22

- 2018-12-27 - 1 Formulär, 13 Item-grupper, 69 Dataelement, 1 Språk
Item-grupper: Administrative data, Day 21, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Laboratory Test - Urine HCG, Pharmacodynamic Blood Collection, Pharmacokinetic Blood Collection, Day 22, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Pharmacokinetic Blood Collection
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 2 Day 1 + Day 5

- 2018-12-27 - 1 Formulär, 15 Item-grupper, 80 Dataelement, 1 Språk
Item-grupper: Administrative data, Day 1, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Hematology Test, Chemistry, UA / UDS / Urine HCG / Urine Chemistry, Pharmacodynamic Blood Collection, Pharmacodynamic Blood Collection 2, Day 5, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Study Drug Administration 2
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 1 Day 12 (Visit 100): Vital Signs, Pharmacodynamics, Drug Administration

- 2018-12-21 - 1 Formulär, 4 Item-grupper, 26 Dataelement, 1 Språk
Item-grupper: Administrative data, Study Drug Administration, Vital Signs, Pharmacodynamic Blood Collection
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 1 Day 1 (Visit 80)

- 2018-12-21 - 1 Formulär, 9 Item-grupper, 49 Dataelement, 1 Språk
Item-grupper: Administrative data, Admission Criteria, Study Drug Administration, Laboratory Test - Hematology, Laboratory Test - Chemistry, Laboratory Test - UA / UDS / Urine HCG / Urine Chemistry, Vital Signs, Pharmacodynamic Blood Collection, Pharmacodynamic Blood Collection
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 2 Day 13 + Day 14

- 2018-12-27 - 1 Formulär, 13 Item-grupper, 72 Dataelement, 1 Språk
Item-grupper: Administrative data, Day 13, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Pharmacodynamic Blood Collection, Day 14, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Electrocardiogram, Overall Interpretation of ECG, Study Drug Administration, Pharmacodynamic Blood Collection
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

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