ID

33111

Beschrijving

The Effect of Byetta and Symlin on Post-meal Meal Blood Sugar Levels in Children With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00950677

Link

https://clinicaltrials.gov/show/NCT00950677

Trefwoorden

Versies (1)
  1. 28-11-18 28-11-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

28 november 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00950677

Engels

Eligibility Type 2 Diabetes NCT00950677

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
children with type 2 diabetes,
Beschrijving

Children | Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2]
C0011860
between the ages of 12-21 years,
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
tanner stage 4-5 for pubertal development,
Beschrijving

Development Pubertal Tanner stage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678723
UMLS CUI [1,2]
C1627769
UMLS CUI [1,3]
C2826146
menstruating females must have a negative urine pregnancy test for inclusion,
Beschrijving

Gender Menstruation Urine pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0025344
UMLS CUI [1,3]
C0430057
must have t2dm for at least 6 months,
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
history of negative anti-glutamic acid decarboxylase (gad) -65 and anti-islet cell antibodies,
Beschrijving

Glutamate decarboxylase 65 antibody Negative | Anti-islet cell antibody negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0806227
UMLS CUI [1,2]
C1513916
UMLS CUI [2]
C3495775
hba1c < 8.5% and on a stable dose of an oral hypoglycemic agent (with or without insulin) over the last 2 months, or well controlled on diet.
Beschrijving

Hemoglobin A1c measurement | Oral hypoglycemic Dose Stable | Insulin | Insulin Absent | Diet Well controlled

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0359086
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C0021641
UMLS CUI [4,1]
C0021641
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0012159
UMLS CUI [5,2]
C3853142
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
a history of a chronic disease other than diabetes (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, dyslipidemia, cholelithiasis etc),
Beschrijving

Chronic disease | Exception Diabetes Mellitus | Leukemia | Asthma | Inflammatory Bowel Diseases | Cystic Fibrosis | Juvenile rheumatoid arthritis | Dyslipidemias | Cholelithiasis

Datatype

boolean

Alias
UMLS CUI [1]
C0008679
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011849
UMLS CUI [3]
C0023418
UMLS CUI [4]
C0004096
UMLS CUI [5]
C0021390
UMLS CUI [6]
C0010674
UMLS CUI [7]
C3714757
UMLS CUI [8]
C0242339
UMLS CUI [9]
C0008350
bmi> 40 kg/m2,
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
weight of < 60 kg,
Beschrijving

Body Weight

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
female with menstrual irregularities,
Beschrijving

Irregular periods

Datatype

boolean

Alias
UMLS CUI [1]
C0156404
allergy to local anesthetics (elamax cream, ethyl chloride),
Beschrijving

Local anesthetic drug allergy | Hypersensitivity Ela-Max | Hypersensitivity Ethyl Chloride

Datatype

boolean

Alias
UMLS CUI [1]
C0570642
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0720170
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0015058
evidence or history of chemical abuse,
Beschrijving

Chemical abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0740858
anemia (age specific normal range for hemoglobin will be used),
Beschrijving

Anemia

Datatype

boolean

Alias
UMLS CUI [1]
C0002871
elevated liver enzymes (defined as more than 3 times the upper limit of the normal range for age),
Beschrijving

Elevated liver enzymes

Datatype

boolean

Alias
UMLS CUI [1]
C0235996
elevated bun or creatinine (defined as more than 3 times the upper limit of the normal range for age),
Beschrijving

Elevated BUN | Serum creatinine raised

Datatype

boolean

Alias
UMLS CUI [1]
C0151539
UMLS CUI [2]
C0700225
use of medications that may increase the blood sugars and admission to the hospital for diabetes related problems over the last 6 months.
Beschrijving

Pharmaceutical Preparations Increasing Blood Glucose | Hospitalization Relation with diabetes-related problem

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0442808
UMLS CUI [1,3]
C0005802
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C3166267
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Similar models

Eligibility Type 2 Diabetes NCT00950677

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Children | Diabetes Mellitus, Non-Insulin-Dependent
Item
children with type 2 diabetes,
boolean
C0008059 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Age
Item
between the ages of 12-21 years,
boolean
C0001779 (UMLS CUI [1])
Development Pubertal Tanner stage
Item
tanner stage 4-5 for pubertal development,
boolean
C0678723 (UMLS CUI [1,1])
C1627769 (UMLS CUI [1,2])
C2826146 (UMLS CUI [1,3])
Gender Menstruation Urine pregnancy test negative
Item
menstruating females must have a negative urine pregnancy test for inclusion,
boolean
C0079399 (UMLS CUI [1,1])
C0025344 (UMLS CUI [1,2])
C0430057 (UMLS CUI [1,3])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
must have t2dm for at least 6 months,
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Glutamate decarboxylase 65 antibody Negative | Anti-islet cell antibody negative
Item
history of negative anti-glutamic acid decarboxylase (gad) -65 and anti-islet cell antibodies,
boolean
C0806227 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C3495775 (UMLS CUI [2])
Hemoglobin A1c measurement | Oral hypoglycemic Dose Stable | Insulin | Insulin Absent | Diet Well controlled
Item
hba1c < 8.5% and on a stable dose of an oral hypoglycemic agent (with or without insulin) over the last 2 months, or well controlled on diet.
boolean
C0474680 (UMLS CUI [1])
C0359086 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0021641 (UMLS CUI [3])
C0021641 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0012159 (UMLS CUI [5,1])
C3853142 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Chronic disease | Exception Diabetes Mellitus | Leukemia | Asthma | Inflammatory Bowel Diseases | Cystic Fibrosis | Juvenile rheumatoid arthritis | Dyslipidemias | Cholelithiasis
Item
a history of a chronic disease other than diabetes (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, dyslipidemia, cholelithiasis etc),
boolean
C0008679 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
C0023418 (UMLS CUI [3])
C0004096 (UMLS CUI [4])
C0021390 (UMLS CUI [5])
C0010674 (UMLS CUI [6])
C3714757 (UMLS CUI [7])
C0242339 (UMLS CUI [8])
C0008350 (UMLS CUI [9])
Body mass index
Item
bmi> 40 kg/m2,
boolean
C1305855 (UMLS CUI [1])
Body Weight
Item
weight of < 60 kg,
boolean
C0005910 (UMLS CUI [1])
Irregular periods
Item
female with menstrual irregularities,
boolean
C0156404 (UMLS CUI [1])
Local anesthetic drug allergy | Hypersensitivity Ela-Max | Hypersensitivity Ethyl Chloride
Item
allergy to local anesthetics (elamax cream, ethyl chloride),
boolean
C0570642 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0720170 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0015058 (UMLS CUI [3,2])
Chemical abuse
Item
evidence or history of chemical abuse,
boolean
C0740858 (UMLS CUI [1])
Anemia
Item
anemia (age specific normal range for hemoglobin will be used),
boolean
C0002871 (UMLS CUI [1])
Elevated liver enzymes
Item
elevated liver enzymes (defined as more than 3 times the upper limit of the normal range for age),
boolean
C0235996 (UMLS CUI [1])
Elevated BUN | Serum creatinine raised
Item
elevated bun or creatinine (defined as more than 3 times the upper limit of the normal range for age),
boolean
C0151539 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
Pharmaceutical Preparations Increasing Blood Glucose | Hospitalization Relation with diabetes-related problem
Item
use of medications that may increase the blood sugars and admission to the hospital for diabetes related problems over the last 6 months.
boolean
C0013227 (UMLS CUI [1,1])
C0442808 (UMLS CUI [1,2])
C0005802 (UMLS CUI [1,3])
C0019993 (UMLS CUI [2,1])
C3166267 (UMLS CUI [2,2])
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