ID

39929

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02271776

Stichworte

Versionen (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
Rechteinhaber

Maastricht University Medical Center

Hochgeladen am

4. März 2020

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Eligibility Obesity NCT02271776

Englisch

Eligibility Obesity NCT02271776

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT02271776
Inclusion Criteria
Beschreibung

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
Beschreibung

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

Datentyp

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).
Beschreibung

recent stable body weight

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
diabetes mellitus
Beschreibung

diabetes mellitus

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

lactose intolerance and other digestive disorders

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

limited life expectancy

Datentyp

boolean

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

drug abuse, alcohol abuse, alcohol units/week

Datentyp

boolean

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

nicotine use, number of cigarettes per day

Datentyp

boolean

Alias
UMLS CUI [1]
C3694146
UMLS CUI [2]
C2363943
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Ähnliche Modelle

Eligibility Obesity NCT02271776

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT02271776
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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