ID

37397

Descripción

Cut Down on Carbohydrate Usage in the Diet of Type 2 Diabetes - Mechanisms of Effective Therapy of Diabetes by Selective Choice of Macronutrients - The Phenotype Study; ODM derived from: https://clinicaltrials.gov/show/NCT02472951

Link

https://clinicaltrials.gov/show/NCT02472951

Palabras clave

Versiones (1)
  1. 22/7/19 22/7/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

22 de julio de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT02472951

Inglés

Eligibility Type 2 Diabetes NCT02472951

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
men age 18-70 years
Descripción

Gender | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
postmenopausal women age 55-70 years
Descripción

Gender | Age | Postmenopausal state

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0232970
non-smoker (abstinent at least 6 months)
Descripción

Non-smoker

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0337672
hba1c < 74 mmol/mol
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
fasting blood glucose < 11 mmol/l (mean of 3 measurements)
Descripción

Fasting blood glucose measurement mean

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0428568
UMLS CUI [1,2]
C0444504
negative (<25 iu/l) plasma glutamate decarboxylase (gad-65) antibodies (igg)
Descripción

Plasma Glutamate decarboxylase 65 antibody Negative | Measurement of glutamate decarboxylase 65 antibody

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C0806227
UMLS CUI [1,3]
C1513916
UMLS CUI [2]
C1295017
hemoglobin > 7.5 mmol/l (men); > 6.8 mmol/l (women)
Descripción

Hemoglobin measurement | Gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
normal thrombocytes (140-400 x 109/l)
Descripción

Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
egfr > 45 ml/min per 1.73 m2
Descripción

Estimated Glomerular Filtration Rate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3811844
alkaline phosphatase < 140 iu/l
Descripción

Alkaline phosphatase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201850
alanine aminotransferase < 70 iu/l
Descripción

Alanine aminotransferase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201836
normal international normalized ratio (0.9-1.2)
Descripción

International Normalized Ratio

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525032
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
critical illness
Descripción

Critical Illness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0010340
anti-diabetic drugs other than metformin (maximum of 2000 mg / day)
Descripción

Antidiabetics U/day Maximum | Exception Metformin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0456683
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
steroid treatment e.g. prednisolone
Descripción

Steroid therapy | prednisolone

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0149783
UMLS CUI [2]
C0032950
reported or journalized severe food allergy or intolerance
Descripción

Food Allergy Severe | Food intolerance Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0016470
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0149696
UMLS CUI [2,2]
C0205082
reported or journalized gut disease e.g. crohn's disease, coeliac disease
Descripción

Gastrointestinal Disease | Crohn Disease | Celiac Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0010346
UMLS CUI [3]
C0007570
reported or journalized alcohol dependence syndrome
Descripción

Alcoholic Intoxication, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001973
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Similar models

Eligibility Type 2 Diabetes NCT02472951

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
men age 18-70 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender | Age | Postmenopausal state
Item
postmenopausal women age 55-70 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
Non-smoker
Item
non-smoker (abstinent at least 6 months)
boolean
C0337672 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c < 74 mmol/mol
boolean
C0474680 (UMLS CUI [1])
Fasting blood glucose measurement mean
Item
fasting blood glucose < 11 mmol/l (mean of 3 measurements)
boolean
C0428568 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Plasma Glutamate decarboxylase 65 antibody Negative | Measurement of glutamate decarboxylase 65 antibody
Item
negative (<25 iu/l) plasma glutamate decarboxylase (gad-65) antibodies (igg)
boolean
C0032105 (UMLS CUI [1,1])
C0806227 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C1295017 (UMLS CUI [2])
Hemoglobin measurement | Gender
Item
hemoglobin > 7.5 mmol/l (men); > 6.8 mmol/l (women)
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Platelet Count measurement
Item
normal thrombocytes (140-400 x 109/l)
boolean
C0032181 (UMLS CUI [1])
Estimated Glomerular Filtration Rate
Item
egfr > 45 ml/min per 1.73 m2
boolean
C3811844 (UMLS CUI [1])
Alkaline phosphatase measurement
Item
alkaline phosphatase < 140 iu/l
boolean
C0201850 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
alanine aminotransferase < 70 iu/l
boolean
C0201836 (UMLS CUI [1])
International Normalized Ratio
Item
normal international normalized ratio (0.9-1.2)
boolean
C0525032 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Critical Illness
Item
critical illness
boolean
C0010340 (UMLS CUI [1])
Antidiabetics U/day Maximum | Exception Metformin
Item
anti-diabetic drugs other than metformin (maximum of 2000 mg / day)
boolean
C0935929 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Steroid therapy | prednisolone
Item
steroid treatment e.g. prednisolone
boolean
C0149783 (UMLS CUI [1])
C0032950 (UMLS CUI [2])
Food Allergy Severe | Food intolerance Severe
Item
reported or journalized severe food allergy or intolerance
boolean
C0016470 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0149696 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Gastrointestinal Disease | Crohn Disease | Celiac Disease
Item
reported or journalized gut disease e.g. crohn's disease, coeliac disease
boolean
C0017178 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
C0007570 (UMLS CUI [3])
Alcoholic Intoxication, Chronic
Item
reported or journalized alcohol dependence syndrome
boolean
C0001973 (UMLS CUI [1])
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