ID

37313

Beschrijving

Peripheral Insulin Uptake in Type 2 Diabetes Mellitus and in Non-Diabetic Individuals; ODM derived from: https://clinicaltrials.gov/show/NCT02031341

Link

https://clinicaltrials.gov/show/NCT02031341

Trefwoorden

Versies (2)
  1. 16-07-19 16-07-19 -
  2. 16-07-19 16-07-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

16 juli 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02031341

Engels

Eligibility Type 2 Diabetes Mellitus NCT02031341

1 Formulieren  
Criteria
Beschrijving

Criteria

written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
hemodynamically stable with a systolic blood pressure > 100 mmhg
Beschrijving

Stable status Hemodynamic | Systolic Pressure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0019010
UMLS CUI [2]
C0871470
medical need to undergo a cag procedure as determined by cardiologist
Beschrijving

Patient need for Coronary angiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0085532
exclusion criteria for all participants:
Beschrijving

Exclusion Criteria Participants All

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0679646
UMLS CUI [1,3]
C0444868
ongoing myocardial infarction as determined from elevated cardiac markers
Beschrijving

Myocardial Infarction | Cardiac markers Elevated

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C1271630
UMLS CUI [2,2]
C3163633
participation in an investigational trial within 90 days prior to present study
Beschrijving

Study Subject Participation Status | Therapies, Investigational

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
donation of blood (> 100 ml) within 90 days prior to present study
Beschrijving

Blood Donation Amount

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
serious mental impairment or language problems i.e. preventing to understand the study protocol/aim
Beschrijving

Mental impairment | Language problems | Study Protocol Comprehension Excluded

Datatype

boolean

Alias
UMLS CUI [1]
C0683322
UMLS CUI [2]
C1405458
UMLS CUI [3,1]
C2348563
UMLS CUI [3,2]
C0162340
UMLS CUI [3,3]
C0332196
use or recent use (within 3 months of study participation) of oral glucocorticoids
Beschrijving

Glucocorticoids Oral

Datatype

boolean

Alias
UMLS CUI [1,1]
C0017710
UMLS CUI [1,2]
C1527415
inclusion criteria for non-diabetic individuals:
Beschrijving

Inclusion criteria Persons Without Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0027361
UMLS CUI [1,3]
C0332288
UMLS CUI [1,4]
C0011849
30 years ≤ age ≤ 80 years (extremes included)
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
fasting glucose level of < 7.0 mmol/l and hba1c < 6.5% (= < 48 mmol/mol)
Beschrijving

Fasting blood glucose measurement | Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0428568
UMLS CUI [2]
C0474680
exclusion criteria for non-diabetic individuals:
Beschrijving

Exclusion Criteria Persons Without Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0027361
UMLS CUI [1,3]
C0332288
UMLS CUI [1,4]
C0011849
known t2dm/use of glucose-lowering medication
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | Hypoglycemic Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0020616
inclusion criteria for t2dm patients:
Beschrijving

Inclusion criteria Non-Insulin-Dependent Diabetes Mellitus Patients

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0011860
UMLS CUI [1,3]
C0030705
30 years ≤ age ≤ 80 years (extremes included)
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
fasting glucose level of > 7.0 mmol/l, or hba1c > 6.5 (= > 48 mmol/mol) or known t2dm
Beschrijving

Fasting blood glucose measurement | Hemoglobin A1c measurement | Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0428568
UMLS CUI [2]
C0474680
UMLS CUI [3]
C0011860
exclusion criteria for t2dm patients:
Beschrijving

Exclusion Criteria Non-Insulin-Dependent Diabetes Mellitus Patients

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0011860
UMLS CUI [1,3]
C0030705
treatment with insulin preparations
Beschrijving

Insulin preparations

Datatype

boolean

Alias
UMLS CUI [1]
C0021641
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02031341

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Stable status Hemodynamic | Systolic Pressure
Item
hemodynamically stable with a systolic blood pressure > 100 mmhg
boolean
C0205360 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
Patient need for Coronary angiography
Item
medical need to undergo a cag procedure as determined by cardiologist
boolean
C0686904 (UMLS CUI [1,1])
C0085532 (UMLS CUI [1,2])
Exclusion Criteria Participants All
Item
exclusion criteria for all participants:
boolean
C0680251 (UMLS CUI [1,1])
C0679646 (UMLS CUI [1,2])
C0444868 (UMLS CUI [1,3])
Myocardial Infarction | Cardiac markers Elevated
Item
ongoing myocardial infarction as determined from elevated cardiac markers
boolean
C0027051 (UMLS CUI [1])
C1271630 (UMLS CUI [2,1])
C3163633 (UMLS CUI [2,2])
Study Subject Participation Status | Therapies, Investigational
Item
participation in an investigational trial within 90 days prior to present study
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Blood Donation Amount
Item
donation of blood (> 100 ml) within 90 days prior to present study
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Mental impairment | Language problems | Study Protocol Comprehension Excluded
Item
serious mental impairment or language problems i.e. preventing to understand the study protocol/aim
boolean
C0683322 (UMLS CUI [1])
C1405458 (UMLS CUI [2])
C2348563 (UMLS CUI [3,1])
C0162340 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
Glucocorticoids Oral
Item
use or recent use (within 3 months of study participation) of oral glucocorticoids
boolean
C0017710 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Inclusion criteria Persons Without Diabetes Mellitus
Item
inclusion criteria for non-diabetic individuals:
boolean
C1512693 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C0011849 (UMLS CUI [1,4])
Age
Item
30 years ≤ age ≤ 80 years (extremes included)
boolean
C0001779 (UMLS CUI [1])
Fasting blood glucose measurement | Hemoglobin A1c measurement
Item
fasting glucose level of < 7.0 mmol/l and hba1c < 6.5% (= < 48 mmol/mol)
boolean
C0428568 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Exclusion Criteria Persons Without Diabetes Mellitus
Item
exclusion criteria for non-diabetic individuals:
boolean
C0680251 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C0011849 (UMLS CUI [1,4])
Diabetes Mellitus, Non-Insulin-Dependent | Hypoglycemic Agents
Item
known t2dm/use of glucose-lowering medication
boolean
C0011860 (UMLS CUI [1])
C0020616 (UMLS CUI [2])
Inclusion criteria Non-Insulin-Dependent Diabetes Mellitus Patients
Item
inclusion criteria for t2dm patients:
boolean
C1512693 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
Age
Item
30 years ≤ age ≤ 80 years (extremes included)
boolean
C0001779 (UMLS CUI [1])
Fasting blood glucose measurement | Hemoglobin A1c measurement | Diabetes Mellitus, Non-Insulin-Dependent
Item
fasting glucose level of > 7.0 mmol/l, or hba1c > 6.5 (= > 48 mmol/mol) or known t2dm
boolean
C0428568 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
Exclusion Criteria Non-Insulin-Dependent Diabetes Mellitus Patients
Item
exclusion criteria for t2dm patients:
boolean
C0680251 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
Insulin preparations
Item
treatment with insulin preparations
boolean
C0021641 (UMLS CUI [1])
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