ID

16100

Beschrijving

Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02315495

Link

https://clinicaltrials.gov/show/NCT02315495

Trefwoorden

Versies (1)
  1. 29-06-16 29-06-16 -
Geüploaded op

29 juni 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Type 2 Diabetes NCT02315495

Engels

Eligibility Type 2 Diabetes NCT02315495

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes (world health organisation (who) criteria), managed by diet alone (i.e. no oral hypoglycaemic drugs or insulin)
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent Diabetic on diet only | Oral hypoglycemic Absent | Insulin Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0421246
UMLS CUI [2,1]
C0359086
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0021641
UMLS CUI [3,2]
C0332197
body mass index (bmi) 20 - 40 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
age 18 - 70 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
males and post-menopausal females (to control for the effect of the menstrual cycle on gut hormone secretion)
Beschrijving

Gender | Postmenopausal state | control Menstrual cycle Effect Gut Hormone secretion

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C0243148
UMLS CUI [3,2]
C0025329
UMLS CUI [3,3]
C1280500
UMLS CUI [3,4]
C0699819
UMLS CUI [3,5]
C0312431
glycated haemoglobin a1c (hba1c) ≥ 6.0% and ≤ 7.9%
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
haemoglobin above the lower limit of the normal range (i.e. >135g/l for men and 115g/l for women), and ferritin above the lower limit of normal (i.e. >10mcg/l)
Beschrijving

Hemoglobin measurement | Gender | Ferritin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0373607
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any medication that may influence gastrointestinal motor function, body weight or appetite
Beschrijving

Pharmaceutical Preparations Affecting function gastrointestinal motor | Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting appetite

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0031843
UMLS CUI [1,4]
C0521362
UMLS CUI [1,5]
C1513492
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0005910
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0003618
evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
Beschrijving

Drug abuse | Alcohol consumption Unit per Gram per Day | Cigarette smoker Number of cigarettes per day

Datatype

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C2349072
UMLS CUI [3,1]
C0337667
UMLS CUI [3,2]
C3694146
history of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
Beschrijving

Gastrointestinal Diseases | Symptoms Significant Upper Gastrointestinal Tract | Symptoms Significant Lower Gastrointestinal Tract | Pancreatitis | Gastrointestinal Surgical Procedure | Appendectomy Uncomplicated | Cholecystectomy Uncomplicated

Datatype

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0750502
UMLS CUI [2,3]
C3203348
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0750502
UMLS CUI [3,3]
C0226875
UMLS CUI [4]
C0030305
UMLS CUI [5]
C0524722
UMLS CUI [6,1]
C0003611
UMLS CUI [6,2]
C0443334
UMLS CUI [7,1]
C0008320
UMLS CUI [7,2]
C0443334
other significant illness, including epilepsy, cardiovascular or respiratory disease
Beschrijving

Illness Significant | Epilepsy | Cardiovascular Diseases | Respiration Disorders

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0014544
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0035204
autonomic nerve damage (as assessed by standardised cardiovascular reflex tests [36])
Beschrijving

Autonomic nerve injury

Datatype

boolean

Alias
UMLS CUI [1]
C0560614
impaired renal or liver function (as assessed by calculated creatinine clearance < 90 ml/min or abnormal liver function tests (> 2 times upper limit of normal range))
Beschrijving

Renal Insufficiency | Liver Dysfunction | Creatinine clearance measurement | Liver function tests abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0086565
UMLS CUI [3]
C0373595
UMLS CUI [4]
C0151766
allergy to vildagliptin or any other 'gliptin'
Beschrijving

Hypersensitivity vildagliptin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1570906
donation of blood within the previous 3 months
Beschrijving

Blood Donation

Datatype

boolean

Alias
UMLS CUI [1]
C0005794
participation in any other research studies within the previous 3 months
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
females who are pre-menopausal
Beschrijving

Premenopause

Datatype

boolean

Alias
UMLS CUI [1]
C0206158
inability to give informed consent
Beschrijving

Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
vegetarians
Beschrijving

Vegetarian

Datatype

boolean

Alias
UMLS CUI [1]
C0042441
Terug naar het begin van de pagina

Similar models

Eligibility Type 2 Diabetes NCT02315495

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent Diabetic on diet only | Oral hypoglycemic Absent | Insulin Absent
Item
type 2 diabetes (world health organisation (who) criteria), managed by diet alone (i.e. no oral hypoglycaemic drugs or insulin)
boolean
C0011860 (UMLS CUI [1,1])
C0421246 (UMLS CUI [1,2])
C0359086 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0021641 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Body mass index
Item
body mass index (bmi) 20 - 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Age
Item
age 18 - 70 years
boolean
C0001779 (UMLS CUI [1])
Gender | Postmenopausal state | control Menstrual cycle Effect Gut Hormone secretion
Item
males and post-menopausal females (to control for the effect of the menstrual cycle on gut hormone secretion)
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0243148 (UMLS CUI [3,1])
C0025329 (UMLS CUI [3,2])
C1280500 (UMLS CUI [3,3])
C0699819 (UMLS CUI [3,4])
C0312431 (UMLS CUI [3,5])
Hemoglobin A1c measurement
Item
glycated haemoglobin a1c (hba1c) ≥ 6.0% and ≤ 7.9%
boolean
C0474680 (UMLS CUI [1])
Hemoglobin measurement | Gender | Ferritin measurement
Item
haemoglobin above the lower limit of the normal range (i.e. >135g/l for men and 115g/l for women), and ferritin above the lower limit of normal (i.e. >10mcg/l)
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0373607 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Affecting function gastrointestinal motor | Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting appetite
Item
use of any medication that may influence gastrointestinal motor function, body weight or appetite
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0031843 (UMLS CUI [1,3])
C0521362 (UMLS CUI [1,4])
C1513492 (UMLS CUI [1,5])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0005910 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0003618 (UMLS CUI [3,3])
Drug abuse | Alcohol consumption Unit per Gram per Day | Cigarette smoker Number of cigarettes per day
Item
evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
boolean
C0013146 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C2349072 (UMLS CUI [2,2])
C0337667 (UMLS CUI [3,1])
C3694146 (UMLS CUI [3,2])
Gastrointestinal Diseases | Symptoms Significant Upper Gastrointestinal Tract | Symptoms Significant Lower Gastrointestinal Tract | Pancreatitis | Gastrointestinal Surgical Procedure | Appendectomy Uncomplicated | Cholecystectomy Uncomplicated
Item
history of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
boolean
C0017178 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C3203348 (UMLS CUI [2,3])
C1457887 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C0226875 (UMLS CUI [3,3])
C0030305 (UMLS CUI [4])
C0524722 (UMLS CUI [5])
C0003611 (UMLS CUI [6,1])
C0443334 (UMLS CUI [6,2])
C0008320 (UMLS CUI [7,1])
C0443334 (UMLS CUI [7,2])
Illness Significant | Epilepsy | Cardiovascular Diseases | Respiration Disorders
Item
other significant illness, including epilepsy, cardiovascular or respiratory disease
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0014544 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
Autonomic nerve injury
Item
autonomic nerve damage (as assessed by standardised cardiovascular reflex tests [36])
boolean
C0560614 (UMLS CUI [1])
Renal Insufficiency | Liver Dysfunction | Creatinine clearance measurement | Liver function tests abnormal
Item
impaired renal or liver function (as assessed by calculated creatinine clearance < 90 ml/min or abnormal liver function tests (> 2 times upper limit of normal range))
boolean
C1565489 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C0151766 (UMLS CUI [4])
Hypersensitivity vildagliptin
Item
allergy to vildagliptin or any other 'gliptin'
boolean
C0020517 (UMLS CUI [1,1])
C1570906 (UMLS CUI [1,2])
Blood Donation
Item
donation of blood within the previous 3 months
boolean
C0005794 (UMLS CUI [1])
Study Subject Participation Status
Item
participation in any other research studies within the previous 3 months
boolean
C2348568 (UMLS CUI [1])
Premenopause
Item
females who are pre-menopausal
boolean
C0206158 (UMLS CUI [1])
Informed Consent Unable
Item
inability to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Vegetarian
Item
vegetarians
boolean
C0042441 (UMLS CUI [1])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial