ID

39373

Descrição

The Effects of Mixed Grain on Blood Glucose and Insulin in Healthy Male; ODM derived from: https://clinicaltrials.gov/show/NCT01840982

Link

https://clinicaltrials.gov/show/NCT01840982

Palavras-chave

Versões (1)
  1. 03/01/2020 03/01/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

3 de janeiro de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Healthy People NCT01840982

Inglês

Eligibility Healthy People NCT01840982

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
males, 19~60years old
Descrição

Gender | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
bodyweight was more than 50 kg with ideal body weight within ±30%
Descrição

Body Weight | Ideal Body Weight Percentage

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2,1]
C0421272
UMLS CUI [2,2]
C0439165
less than 100 mg/dl in fasting blood glucose and less than 140 mg/dl in an oral glucose tolerance test (ogtt)
Descrição

Fasting blood glucose measurement | Oral Glucose Tolerance Test

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0428568
UMLS CUI [2]
C0029161
able to give informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
major medical illness such as cardiovascular, neurologic, psychiatric, renal, pulmonary and hepatic diseases
Descrição

Illness Major | Cardiovascular Diseases | Nervous system disorder | Mental disorders | Kidney Diseases | Lung diseases | Liver diseases

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0027765
UMLS CUI [4]
C0004936
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0024115
UMLS CUI [7]
C0023895
history of disease that could interfere with the test products or impede their absorption such as gastrointestinal disease or gastrointestinal surgery
Descrição

Disease Interferes with Investigational New Drugs | Disease Interferes with Absorption Investigational New Drugs | Gastrointestinal Diseases | Gastrointestinal Surgical Procedure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0013230
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C0013230
UMLS CUI [3]
C0017178
UMLS CUI [4]
C0524722
medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
Descrição

Medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
poor vital sign (systolic blood pressure: below 100 mmhg or above 150 mmhg, diastolic blood pressure: below 65 mmhg or above95 mmhg)
Descrição

Vital signs Poor | Systolic Pressure | Diastolic blood pressure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0542537
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
allergic or hypersensitive to any of the ingredients in the test products; treated with any drug within past 2 weeks
Descrição

Hypersensitivity Investigational New Drugs Ingredient

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1550600
participation in any other clinical trials within past 2 months
Descrição

Study Subject Participation Status | Clinical Trials

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
alcohol consumption above 21 units per week or abnormal screening laboratory test
Descrição

Alcohol consumption Units per week | Laboratory test result abnormal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560588
UMLS CUI [2]
C0438215
being judged by the responsible physician of the local study center as unfit to participate in the study
Descrição

Study Subject Participation Status Medically unfit

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3841806
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Similar models

Eligibility Healthy People NCT01840982

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
males, 19~60years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Body Weight | Ideal Body Weight Percentage
Item
bodyweight was more than 50 kg with ideal body weight within ±30%
boolean
C0005910 (UMLS CUI [1])
C0421272 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Fasting blood glucose measurement | Oral Glucose Tolerance Test
Item
less than 100 mg/dl in fasting blood glucose and less than 140 mg/dl in an oral glucose tolerance test (ogtt)
boolean
C0428568 (UMLS CUI [1])
C0029161 (UMLS CUI [2])
Informed Consent
Item
able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Illness Major | Cardiovascular Diseases | Nervous system disorder | Mental disorders | Kidney Diseases | Lung diseases | Liver diseases
Item
major medical illness such as cardiovascular, neurologic, psychiatric, renal, pulmonary and hepatic diseases
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0004936 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0024115 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
Disease Interferes with Investigational New Drugs | Disease Interferes with Absorption Investigational New Drugs | Gastrointestinal Diseases | Gastrointestinal Surgical Procedure
Item
history of disease that could interfere with the test products or impede their absorption such as gastrointestinal disease or gastrointestinal surgery
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C0017178 (UMLS CUI [3])
C0524722 (UMLS CUI [4])
Medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status
Item
medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Vital signs Poor | Systolic Pressure | Diastolic blood pressure
Item
poor vital sign (systolic blood pressure: below 100 mmhg or above 150 mmhg, diastolic blood pressure: below 65 mmhg or above95 mmhg)
boolean
C0518766 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs Ingredient
Item
allergic or hypersensitive to any of the ingredients in the test products; treated with any drug within past 2 weeks
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
Study Subject Participation Status | Clinical Trials
Item
participation in any other clinical trials within past 2 months
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Alcohol consumption Units per week | Laboratory test result abnormal
Item
alcohol consumption above 21 units per week or abnormal screening laboratory test
boolean
C0001948 (UMLS CUI [1,1])
C0560588 (UMLS CUI [1,2])
C0438215 (UMLS CUI [2])
Study Subject Participation Status Medically unfit
Item
being judged by the responsible physician of the local study center as unfit to participate in the study
boolean
C2348568 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
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