ID

39371

Beschreibung

Effect of Genetic Variants in MATE1 and OCT3 on the Pharmacodynamics of Metformin in African Americans; ODM derived from: https://clinicaltrials.gov/show/NCT01681693

Link

https://clinicaltrials.gov/show/NCT01681693

Stichworte

Versionen (1)
  1. 03.01.20 03.01.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

3. Januar 2020

DOI

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Creative Commons BY 4.0
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Eligibility Healthy NCT01681693

Englisch

Eligibility Healthy NCT01681693

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Healthy NCT01681693
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects self-identify racial background, identify themselves, parents and four grandparents as african american
Beschreibung

African American | Parent African American | Grandparent Quantity African American

Datentyp

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2,1]
C0030551
UMLS CUI [2,2]
C0085756
UMLS CUI [3,1]
C0337471
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0085756
subject status is healthy volunteer from t in the event that diabetes is indicated in a normal subject based on ogtt results, we will notify the patients' primary care physician. he sophie cohort or diagnosis of t2dm based on american diabetes association (ada) criteria
Beschreibung

Healthy Volunteers | Indication Diabetes Mellitus Oral Glucose Tolerance Test | Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0011849
UMLS CUI [2,3]
C0029161
UMLS CUI [3]
C0011860
subjects over 18 years old and below 60 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
subjects who are healthy on the basis of medical history, physical examinations and laboratory tests if healthy volunteer from sophie
Beschreibung

Healthy Medical History | Healthy Physical Examination | Healthy Laboratory Procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3898900
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C3898900
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C3898900
UMLS CUI [3,2]
C0022885
subjects who agree with the written informed consent to participate in the study
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
unable to confirm african-american ethnicity
Beschreibung

Confirmation of African American Ethnicity Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521091
UMLS CUI [1,2]
C4540921
UMLS CUI [1,3]
C0332268
under 18 years old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
pregnant or lactating women (female subjects will have a urine pregnancy test at the screening visit).
Beschreibung

Pregnancy | Breast Feeding | Gender Urine pregnancy test

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0430056
prior history of any allergic reaction to metformin
Beschreibung

Metformin allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0571648
has a risk of congestive heart failure requiring pharmacologic treatment (medical history)
Beschreibung

At risk Congestive heart failure | Requirement Pharmacotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1444641
UMLS CUI [1,2]
C0018802
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0013216
has a prior history of renal* or hepatic dysfunction (renal and hepatic function will be evaluated based on screening blood tests conducted prior to study enrollment)
Beschreibung

Renal dysfunction Previous | Liver Dysfunction Previous | Renal function Hematologic Test | Liver function Hematologic Test

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3279454
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C0232804
UMLS CUI [3,2]
C0018941
UMLS CUI [4,1]
C0232741
UMLS CUI [4,2]
C0018941
risk of urinary or gastric retention or narrow-angle glaucoma (by medical history examination)
Beschreibung

At risk Urinary Retention | At risk Gastric retention | At risk Angle Closure Glaucoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1444641
UMLS CUI [1,2]
C0080274
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0585136
UMLS CUI [3,1]
C1444641
UMLS CUI [3,2]
C0017605
impaired renal function (e.g as suggested by abnormal creatinine clearance, egfr <60 or serum creatinine >1.4 mg/dl in females and >1.5 mg/dl in males) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction (heart attack), and septicemia, abnormal heart rhythms (tachyarrhythmias; heart beat > 100 beats per minute).
Beschreibung

Renal Insufficiency | Creatinine clearance measurement Abnormal | Estimated Glomerular Filtration Rate | Creatinine measurement, serum | Gender | Shock | Myocardial Infarction | Septicemia | Cardiac Arrhythmia | Tachyarrhythmia | Heart beat BPM

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2,1]
C0373595
UMLS CUI [2,2]
C0205161
UMLS CUI [3]
C3811844
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0079399
UMLS CUI [6]
C0036974
UMLS CUI [7]
C0027051
UMLS CUI [8]
C0036690
UMLS CUI [9]
C0003811
UMLS CUI [10]
C0080203
UMLS CUI [11,1]
C0425583
UMLS CUI [11,2]
C0439385
impaired hepatic function (> 1.5 times the upper limit of normal)
Beschreibung

Liver Dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
evidence of anemia (hemoglobin <10 g)
Beschreibung

Anemia | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
taking a medication that could confound study results, such as known substrates or inhibitors of oct3 and mate1, such as cimetidine.
Beschreibung

Pharmaceutical Preparations Interfere with Research results | SLC22A3 Substrate | SLC22A3 Inhibitor | SLC47A1 Substrate | SLC47A1 Inhibitor | Cimetidine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C1420138
UMLS CUI [2,2]
C3891814
UMLS CUI [3,1]
C1420138
UMLS CUI [3,2]
C1999216
UMLS CUI [4,1]
C1853262
UMLS CUI [4,2]
C3891814
UMLS CUI [5,1]
C1853262
UMLS CUI [5,2]
C1999216
UMLS CUI [6]
C0008783
they do not provide consent to participate in the study.
Beschreibung

Informed Consent Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
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Ähnliche Modelle

Eligibility Healthy NCT01681693

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Healthy NCT01681693
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
African American | Parent African American | Grandparent Quantity African American
Item
subjects self-identify racial background, identify themselves, parents and four grandparents as african american
boolean
C0085756 (UMLS CUI [1])
C0030551 (UMLS CUI [2,1])
C0085756 (UMLS CUI [2,2])
C0337471 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0085756 (UMLS CUI [3,3])
Healthy Volunteers | Indication Diabetes Mellitus Oral Glucose Tolerance Test | Diabetes Mellitus, Non-Insulin-Dependent
Item
subject status is healthy volunteer from t in the event that diabetes is indicated in a normal subject based on ogtt results, we will notify the patients' primary care physician. he sophie cohort or diagnosis of t2dm based on american diabetes association (ada) criteria
boolean
C1708335 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
C0029161 (UMLS CUI [2,3])
C0011860 (UMLS CUI [3])
Age
Item
subjects over 18 years old and below 60 years
boolean
C0001779 (UMLS CUI [1])
Healthy Medical History | Healthy Physical Examination | Healthy Laboratory Procedures
Item
subjects who are healthy on the basis of medical history, physical examinations and laboratory tests if healthy volunteer from sophie
boolean
C3898900 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C3898900 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C3898900 (UMLS CUI [3,1])
C0022885 (UMLS CUI [3,2])
Informed Consent
Item
subjects who agree with the written informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Confirmation of African American Ethnicity Lacking
Item
unable to confirm african-american ethnicity
boolean
C0521091 (UMLS CUI [1,1])
C4540921 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Age
Item
under 18 years old
boolean
C0001779 (UMLS CUI [1])
Pregnancy | Breast Feeding | Gender Urine pregnancy test
Item
pregnant or lactating women (female subjects will have a urine pregnancy test at the screening visit).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0430056 (UMLS CUI [3,2])
Metformin allergy
Item
prior history of any allergic reaction to metformin
boolean
C0571648 (UMLS CUI [1])
At risk Congestive heart failure | Requirement Pharmacotherapy
Item
has a risk of congestive heart failure requiring pharmacologic treatment (medical history)
boolean
C1444641 (UMLS CUI [1,1])
C0018802 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0013216 (UMLS CUI [2,2])
Renal dysfunction Previous | Liver Dysfunction Previous | Renal function Hematologic Test | Liver function Hematologic Test
Item
has a prior history of renal* or hepatic dysfunction (renal and hepatic function will be evaluated based on screening blood tests conducted prior to study enrollment)
boolean
C3279454 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3,1])
C0018941 (UMLS CUI [3,2])
C0232741 (UMLS CUI [4,1])
C0018941 (UMLS CUI [4,2])
At risk Urinary Retention | At risk Gastric retention | At risk Angle Closure Glaucoma
Item
risk of urinary or gastric retention or narrow-angle glaucoma (by medical history examination)
boolean
C1444641 (UMLS CUI [1,1])
C0080274 (UMLS CUI [1,2])
C1444641 (UMLS CUI [2,1])
C0585136 (UMLS CUI [2,2])
C1444641 (UMLS CUI [3,1])
C0017605 (UMLS CUI [3,2])
Renal Insufficiency | Creatinine clearance measurement Abnormal | Estimated Glomerular Filtration Rate | Creatinine measurement, serum | Gender | Shock | Myocardial Infarction | Septicemia | Cardiac Arrhythmia | Tachyarrhythmia | Heart beat BPM
Item
impaired renal function (e.g as suggested by abnormal creatinine clearance, egfr <60 or serum creatinine >1.4 mg/dl in females and >1.5 mg/dl in males) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction (heart attack), and septicemia, abnormal heart rhythms (tachyarrhythmias; heart beat > 100 beats per minute).
boolean
C1565489 (UMLS CUI [1])
C0373595 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C3811844 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
C0036974 (UMLS CUI [6])
C0027051 (UMLS CUI [7])
C0036690 (UMLS CUI [8])
C0003811 (UMLS CUI [9])
C0080203 (UMLS CUI [10])
C0425583 (UMLS CUI [11,1])
C0439385 (UMLS CUI [11,2])
Liver Dysfunction
Item
impaired hepatic function (> 1.5 times the upper limit of normal)
boolean
C0086565 (UMLS CUI [1])
Anemia | Hemoglobin measurement
Item
evidence of anemia (hemoglobin <10 g)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Pharmaceutical Preparations Interfere with Research results | SLC22A3 Substrate | SLC22A3 Inhibitor | SLC47A1 Substrate | SLC47A1 Inhibitor | Cimetidine
Item
taking a medication that could confound study results, such as known substrates or inhibitors of oct3 and mate1, such as cimetidine.
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C1420138 (UMLS CUI [2,1])
C3891814 (UMLS CUI [2,2])
C1420138 (UMLS CUI [3,1])
C1999216 (UMLS CUI [3,2])
C1853262 (UMLS CUI [4,1])
C3891814 (UMLS CUI [4,2])
C1853262 (UMLS CUI [5,1])
C1999216 (UMLS CUI [5,2])
C0008783 (UMLS CUI [6])
Informed Consent Lacking
Item
they do not provide consent to participate in the study.
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
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