ID

33146

Description

Different Insulin Regimens and Postprandial Coagulation Activation; ODM derived from: https://clinicaltrials.gov/show/NCT01053234

Link

https://clinicaltrials.gov/show/NCT01053234

Keywords

Versions (2)
  1. 11/29/18 11/29/18 -
  2. 11/29/18 11/29/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 29, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT01053234

English

Eligibility Type 2 Diabetes NCT01053234

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 30-75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
bmi > 25 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
type 2 diabetes for more than 4 years
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
pharmacological anti-diabetic treatment with insulin nph at bedtime or insulin aspart at meals for more than 24 months
Description

Antidiabetics | Insulin NPH Bedtime | Insulin Aspart Meal

Data type

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C0021658
UMLS CUI [2,2]
C0521112
UMLS CUI [3,1]
C1708521
UMLS CUI [3,2]
C1998602
metformin with stable dose >1000 mg/d for more than 12 weeks
Description

Metformin Dose Stable U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
acetylsalicylic acid (75 mg/d) for more than 2 weeks
Description

Aspirin Dose U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
no other anti-diabetic treatment 3 month previously
Description

Antidiabetics Other Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0332197
hba1c<8.5% at recruitment.
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
creatinine > 120 µmol/l
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
alat /asat > 2.5 x upper reference limit
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
use of anticoagulants within 1 month previously
Description

Anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C0003280
any changes in dose of statins within 1 month previously
Description

Statins Dose Change

Data type

boolean

Alias
UMLS CUI [1,1]
C0360714
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0392747
night work
Description

Night work

Data type

boolean

Alias
UMLS CUI [1]
C1659095
present or planned pregnancy
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
mental sickness or alcohol abuse
Description

Mental disorders | Alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0085762
clinically relevant major organ or systemic illness
Description

Illness Organ Major | Systemic disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C0205164
UMLS CUI [2]
C0442893
uncontrolled hypertension >180/110 mmhg
Description

Uncontrolled hypertension | Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0005824
steroid treatment
Description

Steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0149783
known or suspected allergy to trial medications.
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
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Similar models

Eligibility Type 2 Diabetes NCT01053234

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 30-75 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
bmi > 25 kg/m2
boolean
C1305855 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes for more than 4 years
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Antidiabetics | Insulin NPH Bedtime | Insulin Aspart Meal
Item
pharmacological anti-diabetic treatment with insulin nph at bedtime or insulin aspart at meals for more than 24 months
boolean
C0935929 (UMLS CUI [1])
C0021658 (UMLS CUI [2,1])
C0521112 (UMLS CUI [2,2])
C1708521 (UMLS CUI [3,1])
C1998602 (UMLS CUI [3,2])
Metformin Dose Stable U/day
Item
metformin with stable dose >1000 mg/d for more than 12 weeks
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
Aspirin Dose U/day
Item
acetylsalicylic acid (75 mg/d) for more than 2 weeks
boolean
C0004057 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Antidiabetics Other Absent
Item
no other anti-diabetic treatment 3 month previously
boolean
C0935929 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Hemoglobin A1c measurement
Item
hba1c<8.5% at recruitment.
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Creatinine measurement, serum
Item
creatinine > 120 µmol/l
boolean
C0201976 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alat /asat > 2.5 x upper reference limit
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Anticoagulants
Item
use of anticoagulants within 1 month previously
boolean
C0003280 (UMLS CUI [1])
Statins Dose Change
Item
any changes in dose of statins within 1 month previously
boolean
C0360714 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
Night work
Item
night work
boolean
C1659095 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned
Item
present or planned pregnancy
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Mental disorders | Alcohol abuse
Item
mental sickness or alcohol abuse
boolean
C0004936 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
Illness Organ Major | Systemic disease
Item
clinically relevant major organ or systemic illness
boolean
C0221423 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0442893 (UMLS CUI [2])
Uncontrolled hypertension | Blood pressure determination
Item
uncontrolled hypertension >180/110 mmhg
boolean
C1868885 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
Steroid therapy
Item
steroid treatment
boolean
C0149783 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs
Item
known or suspected allergy to trial medications.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
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