ID

39929

Beschrijving

GOS and Insulin Sensitivity; ODM derived from: https://clinicaltrials.gov/show/NCT02271776

Link

https://clinicaltrials.gov/show/NCT02271776

Trefwoorden

Versies (3)
  1. 17-01-19 17-01-19 -
  2. 28-02-20 28-02-20 - Christian Arras
  3. 04-03-20 04-03-20 - Christian Arras
Houder van rechten

Maastricht University Medical Center

Geüploaded op

4 maart 2020

DOI

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Licentie

Creative Commons BY-NC 4.0
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Eligibility Obesity NCT02271776

Engels

Eligibility Obesity NCT02271776

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT02271776
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
Overweight/obese (BMI ≥ 28 kg/m2 < 40 kg/m2) insulin impaired men and post-menopausal women with impaired glucose tolerance (IGT: 2h plasma glucose during 75g OGTT 7.8-11.1 mmol/l) and/or impaired fasting glucose (plasma glucose ≥ 5.6 mmol/l) aged 45-70 years
Beschrijving

Age, gender, Body mass index, Overweight, Insulin impaired, impaired glucose tolerance, Oral glucose tolerance test, impaired fasting glucose, postmenopausal state,

Datatype

text

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C1305855
UMLS CUI [4]
C0497406
UMLS CUI [5,1]
C0021641
UMLS CUI [5,2]
C0221099
UMLS CUI [6]
C0271650
UMLS CUI [7]
C0029161
UMLS CUI [8]
C0232970
UMLS CUI [9,1]
C0583513
UMLS CUI [9,2]
C0221099
in addition, subjects have to be weight-stable for at least 3 months prior to participation (no change in bodyweight, i.e. < 3kg).
Beschrijving

recent stable body weight

Datatype

boolean

Alias
UMLS CUI [1,1]
C0517386
UMLS CUI [1,2]
C0332185
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
diabetes mellitus
Beschrijving

diabetes mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C0011849
gastroenterological diseases or major abdominal surgery (allowed i.e.: appendectomy, cholecystectomy)
Beschrijving

gastrointestinal diseases or major abdominal surgery, except for appendectomy, cholecystectomy

Datatype

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0455612
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0003611
UMLS CUI [4,1]
C0332300
UMLS CUI [4,2]
C0008320
lactose intolerance and other digestive disorders
Beschrijving

lactose intolerance and other digestive disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0022951
UMLS CUI [2]
C0266806
cardiovascular disease, cancer, liver or kidney malfunction (determined based on alat and creatinine levels, respectively)
Beschrijving

cardiovascular disease, cancer, liver malfunction, ALAT measurement, kidney malfunction, Creatinine measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0086565
UMLS CUI [4]
C0201836
UMLS CUI [5]
C3279454
UMLS CUI [6]
C0201975
disease with a life expectancy shorter than 5 years
Beschrijving

limited life expectancy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0439801
UMLS CUI [1,2]
C0023671
abuse of products (alcohol consumption > 15 units/week, or any drugs)
Beschrijving

drug abuse, alcohol abuse, alcohol units/week

Datatype

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C0085762
UMLS CUI [3]
C0560579
excessive nicotine use defined as >20 cigarettes per day
Beschrijving

nicotine use, number of cigarettes per day

Datatype

boolean

Alias
UMLS CUI [1]
C3694146
UMLS CUI [2]
C2363943
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Similar models

Eligibility Obesity NCT02271776

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT02271776
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age, gender, Body mass index, Overweight, Insulin impaired, impaired glucose tolerance, Oral glucose tolerance test, impaired fasting glucose, postmenopausal state,
Item
Overweight/obese (BMI ≥ 28 kg/m2 < 40 kg/m2) insulin impaired men and post-menopausal women with impaired glucose tolerance (IGT: 2h plasma glucose during 75g OGTT 7.8-11.1 mmol/l) and/or impaired fasting glucose (plasma glucose ≥ 5.6 mmol/l) aged 45-70 years
text
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1305855 (UMLS CUI [3])
C0497406 (UMLS CUI [4])
C0021641 (UMLS CUI [5,1])
C0221099 (UMLS CUI [5,2])
C0271650 (UMLS CUI [6])
C0029161 (UMLS CUI [7])
C0232970 (UMLS CUI [8])
C0583513 (UMLS CUI [9,1])
C0221099 (UMLS CUI [9,2])
recent stable body weight
Item
in addition, subjects have to be weight-stable for at least 3 months prior to participation (no change in bodyweight, i.e. < 3kg).
boolean
C0517386 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
diabetes mellitus
Item
diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
gastrointestinal diseases or major abdominal surgery, except for appendectomy, cholecystectomy
Item
gastroenterological diseases or major abdominal surgery (allowed i.e.: appendectomy, cholecystectomy)
boolean
C0017178 (UMLS CUI [1])
C0455612 (UMLS CUI [2])
C0332300 (UMLS CUI [3,1])
C0003611 (UMLS CUI [3,2])
C0332300 (UMLS CUI [4,1])
C0008320 (UMLS CUI [4,2])
lactose intolerance and other digestive disorders
Item
lactose intolerance and other digestive disorders
boolean
C0022951 (UMLS CUI [1])
C0266806 (UMLS CUI [2])
cardiovascular disease, cancer, liver malfunction, ALAT measurement, kidney malfunction, Creatinine measurement
Item
cardiovascular disease, cancer, liver or kidney malfunction (determined based on alat and creatinine levels, respectively)
boolean
C0007222 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0086565 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C3279454 (UMLS CUI [5])
C0201975 (UMLS CUI [6])
limited life expectancy
Item
disease with a life expectancy shorter than 5 years
boolean
C0439801 (UMLS CUI [1,1])
C0023671 (UMLS CUI [1,2])
drug abuse, alcohol abuse, alcohol units/week
Item
abuse of products (alcohol consumption > 15 units/week, or any drugs)
boolean
C0013146 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
C0560579 (UMLS CUI [3])
nicotine use, number of cigarettes per day
Item
excessive nicotine use defined as >20 cigarettes per day
boolean
C3694146 (UMLS CUI [1])
C2363943 (UMLS CUI [2])
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