ID

38843

Description

Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00795600

Link

https://clinicaltrials.gov/show/NCT00795600

Keywords

Versions (1)
  1. 11/9/19 11/9/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 9, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT00795600

English

Eligibility Diabetes NCT00795600

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00795600
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with type 2 diabetes who have been treated with 2 or 3 doses of insulin (one of them must be a premix) for at least 3 months prior to inclusion in trial
Description

Diabetes Mellitus, Non-Insulin-Dependent | Insulin Dose Quantity | Premixed insulin

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C2069057
glycosylated haemoglobin (hba1c) between 7.0-11.0 %
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) between 27.5-40 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with any oral antidiabetic drugs (oads) in the last 6 months except metformin (subjects currently treated with metformin within the interval of 1000 -
Description

Antidiabetics Oral | Exception Metformin

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
2550 mg daily may be included in the trial. the dose should have remained unchanged for a period of 2 months prior to randomisation and should be expected to remain unchanged throughout the trial period)
Description

Eligibility | Metformin Dose U/day | Dose unchanged

Data type

boolean

Alias
UMLS CUI [1]
C1548635
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C0178602
UMLS CUI [3,2]
C0442739
use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramin, rimonabant) or obesity induced by drug treatment (e.g. corticosteroids, non-steroidal anti-inflammatory drugs (nsaids), tricyclic anti-depressants, atypical anti-psychotics)
Description

Weight-Loss Agents | orlistat | sibutramine | rimonabant | Obesity Pharmacotherapy Induced | Adrenal Cortex Hormones | Anti-Inflammatory Agents, Non-Steroidal | Tricyclic Antidepressive Agents | Atypical antipsychotic

Data type

boolean

Alias
UMLS CUI [1]
C0376606
UMLS CUI [2]
C0076275
UMLS CUI [3]
C0074493
UMLS CUI [4]
C1142933
UMLS CUI [5,1]
C0028754
UMLS CUI [5,2]
C0013216
UMLS CUI [5,3]
C0205263
UMLS CUI [6]
C0001617
UMLS CUI [7]
C0003211
UMLS CUI [8]
C0003290
UMLS CUI [9]
C1276996
previous or planned surgical treatment of obesity
Description

Obesity surgery | Obesity surgery Planned

Data type

boolean

Alias
UMLS CUI [1]
C1167841
UMLS CUI [2,1]
C1167841
UMLS CUI [2,2]
C1301732
total daily insulin dose higher or equal 2 iu/kg
Description

Insulin Cumulative Dose u/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C2986497
UMLS CUI [1,3]
C0456683
proliferative retinopathy or maculopathy that has required acute treatment within the last six months
Description

Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0332121
receipt of any investigational drug within 1 month prior to this trial
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
cardiac disease defined according to new york heart association (nyha) class iii or iv, unstable angina pectoris and/or myocardial infarction within the last 6 months previous to the selection
Description

Heart Disease New York Heart Association Classification | Angina, Unstable | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027051
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Similar models

Eligibility Diabetes NCT00795600

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00795600
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Insulin Dose Quantity | Premixed insulin
Item
subjects with type 2 diabetes who have been treated with 2 or 3 doses of insulin (one of them must be a premix) for at least 3 months prior to inclusion in trial
boolean
C0011860 (UMLS CUI [1])
C0021641 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C2069057 (UMLS CUI [3])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin (hba1c) between 7.0-11.0 %
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) between 27.5-40 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antidiabetics Oral | Exception Metformin
Item
treatment with any oral antidiabetic drugs (oads) in the last 6 months except metformin (subjects currently treated with metformin within the interval of 1000 -
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Eligibility | Metformin Dose U/day | Dose unchanged
Item
2550 mg daily may be included in the trial. the dose should have remained unchanged for a period of 2 months prior to randomisation and should be expected to remain unchanged throughout the trial period)
boolean
C1548635 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0178602 (UMLS CUI [3,1])
C0442739 (UMLS CUI [3,2])
Weight-Loss Agents | orlistat | sibutramine | rimonabant | Obesity Pharmacotherapy Induced | Adrenal Cortex Hormones | Anti-Inflammatory Agents, Non-Steroidal | Tricyclic Antidepressive Agents | Atypical antipsychotic
Item
use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramin, rimonabant) or obesity induced by drug treatment (e.g. corticosteroids, non-steroidal anti-inflammatory drugs (nsaids), tricyclic anti-depressants, atypical anti-psychotics)
boolean
C0376606 (UMLS CUI [1])
C0076275 (UMLS CUI [2])
C0074493 (UMLS CUI [3])
C1142933 (UMLS CUI [4])
C0028754 (UMLS CUI [5,1])
C0013216 (UMLS CUI [5,2])
C0205263 (UMLS CUI [5,3])
C0001617 (UMLS CUI [6])
C0003211 (UMLS CUI [7])
C0003290 (UMLS CUI [8])
C1276996 (UMLS CUI [9])
Obesity surgery | Obesity surgery Planned
Item
previous or planned surgical treatment of obesity
boolean
C1167841 (UMLS CUI [1])
C1167841 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Insulin Cumulative Dose u/day
Item
total daily insulin dose higher or equal 2 iu/kg
boolean
C0021641 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for
Item
proliferative retinopathy or maculopathy that has required acute treatment within the last six months
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Investigational New Drugs
Item
receipt of any investigational drug within 1 month prior to this trial
boolean
C0013230 (UMLS CUI [1])
Heart Disease New York Heart Association Classification | Angina, Unstable | Myocardial Infarction
Item
cardiac disease defined according to new york heart association (nyha) class iii or iv, unstable angina pectoris and/or myocardial infarction within the last 6 months previous to the selection
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
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