ID

45902

Beschrijving

Principal Investigator: Rex Chisholm, PhD, Northwestern University MeSH: Diabetes Mellitus, Type 2 https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000984 Type 2 Diabetes Mellitus (T2DM) is a chronic and sometimes debilitating disease that affects millions of adults in the USA. Metformin is commonly prescribed for T2DM; yet some T2DM patients do not tolerate it or respond well. This pharmacogenomics study will examine response, as both change in T2DM patients' weight and hemoglobin A1c (HbA1c) levels, to different doses of metformin, by extracting this data from the electronic health record (EHR), for T2DM subjects taking metformin found by prescription orders in the EHR, and identified as cases with the EHR phenotype algorithm published by Kho et. al. in 2012 (PMID: 22101970 as part of the eMERGE (electronic Medical Records and Genomics; dbGaP phs000237, phs000297, phs000360, phs000368, phs000888, and phs000948) project.

Link

dbGaP study = phs000984

Trefwoorden

  1. 13-12-23 13-12-23 - Simon Heim
Houder van rechten

Rex Chisholm, PhD, Northwestern University

Geüploaded op

13 december 2023

DOI

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Licentie

Creative Commons BY 4.0

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dbGaP phs000984 Pharmacogenomics of Metformin Dose Response in T2DM Patients

Eligibility Criteria

  1. StudyEvent: SEV1
    1. Eligibility Criteria
    2. This subject consent data table includes subjects IDs, consent information, mapping to subject aliases, and affection status for subject with type 2 diabetes mellitus (T2DM) taking metformin.
    3. This subject sample mapping data table includes a mapping of study subject IDs to sample IDs. Samples are the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs. The data table also includes sample aliases and sample use.
    4. This subject phenotype data table includes subjects year and decade of birth, gender, race, ethnicity, and case/control status for subject with type 2 diabetes mellitus (T2DM) taking metformin.
    5. This sample attributes data table includes body site where sample was collected, analyte type, tumor status, and histological type.
    6. This data table includes HbA1c measurements, age when the measurements were taken, and the index number which uniquely indentifies lab values within each year.
    7. This data table includes weight measurements, binary flag indicating possible pregnancy around time of weight measure, age when weight was recorded, and the index number which uniquely indentifies lab values within each year.
    8. This pedigree data table includes family ID, subject ID, father and mother ID, and subject gender to link subjects of the same family.
Inclusion and exclusion criteria
Beschrijving

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
Subjects were determined using an electronic algorithm for type 2 diabetes mellitus deployed with an existing EMR that was previously published by Kho AN, Hayes MG, Rasmussen-Torvik L, et al. Use of diverse electronic medical record systems to identify genetic risk for type 2 diabetes within a genome-wide association study. J Am Med Inform Assoc. 2012 Mar-Apr;19(2):212-8. Epub 2011 Nov 19. PMID: 22101970.
Beschrijving

Subjects were determined using an electronic algorithm for type 2 diabetes mellitus deployed with an existing EMR that was previously published by Kho AN, Hayes MG, Rasmussen-Torvik L, et al. Use of diverse electronic medical record systems to identify genetic risk for type 2 diabetes within a genome-wide association study. J Am Med Inform Assoc. 2012 Mar-Apr;19(2):212-8. Epub 2011 Nov 19. PMID: 22101970.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1148554
UMLS CUI [1,3]
C0002045
UMLS CUI [1,4]
C4014362
UMLS CUI [1,5]
C2362543
UMLS CUI [1,6]
C1704324
UMLS CUI [1,7]
C1517512
UMLS CUI [1,8]
C0205396
UMLS CUI [1,9]
C2350277
Additional inclusion criteria included having been prescribed metformin.
Beschrijving

Additional inclusion criteria included having been prescribed metformin.

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0025598
UMLS CUI [1,3]
C0278329
There were no additional exclusion criteria.
Beschrijving

There were no additional exclusion criteria.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1298908

Similar models

Eligibility Criteria

  1. StudyEvent: SEV1
    1. Eligibility Criteria
    2. This subject consent data table includes subjects IDs, consent information, mapping to subject aliases, and affection status for subject with type 2 diabetes mellitus (T2DM) taking metformin.
    3. This subject sample mapping data table includes a mapping of study subject IDs to sample IDs. Samples are the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs. The data table also includes sample aliases and sample use.
    4. This subject phenotype data table includes subjects year and decade of birth, gender, race, ethnicity, and case/control status for subject with type 2 diabetes mellitus (T2DM) taking metformin.
    5. This sample attributes data table includes body site where sample was collected, analyte type, tumor status, and histological type.
    6. This data table includes HbA1c measurements, age when the measurements were taken, and the index number which uniquely indentifies lab values within each year.
    7. This data table includes weight measurements, binary flag indicating possible pregnancy around time of weight measure, age when weight was recorded, and the index number which uniquely indentifies lab values within each year.
    8. This pedigree data table includes family ID, subject ID, father and mother ID, and subject gender to link subjects of the same family.
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])
Subjects were determined using an electronic algorithm for type 2 diabetes mellitus deployed with an existing EMR that was previously published by Kho AN, Hayes MG, Rasmussen-Torvik L, et al. Use of diverse electronic medical record systems to identify genetic risk for type 2 diabetes within a genome-wide association study. J Am Med Inform Assoc. 2012 Mar-Apr;19(2):212-8. Epub 2011 Nov 19. PMID: 22101970.
Item
Subjects were determined using an electronic algorithm for type 2 diabetes mellitus deployed with an existing EMR that was previously published by Kho AN, Hayes MG, Rasmussen-Torvik L, et al. Use of diverse electronic medical record systems to identify genetic risk for type 2 diabetes within a genome-wide association study. J Am Med Inform Assoc. 2012 Mar-Apr;19(2):212-8. Epub 2011 Nov 19. PMID: 22101970.
boolean
C0681850 (UMLS CUI [1,1])
C1148554 (UMLS CUI [1,2])
C0002045 (UMLS CUI [1,3])
C4014362 (UMLS CUI [1,4])
C2362543 (UMLS CUI [1,5])
C1704324 (UMLS CUI [1,6])
C1517512 (UMLS CUI [1,7])
C0205396 (UMLS CUI [1,8])
C2350277 (UMLS CUI [1,9])
Additional inclusion criteria included having been prescribed metformin.
Item
Additional inclusion criteria included having been prescribed metformin.
boolean
C1512693 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C0278329 (UMLS CUI [1,3])
There were no additional exclusion criteria.
Item
There were no additional exclusion criteria.
boolean
C0680251 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])

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