ID

5115

Description

ODM derived from http://clinicaltrials.gov/show/NCT01272232

Link

http://clinicaltrials.gov/show/NCT01272232

Keywords

Versions (2)
  1. 2/22/13 2/22/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
Uploaded on

April 19, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01272232 Obesity

German English

Eligibility

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

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Procurement of patient informed consent, investigational study
Description

Informed consent obtained

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
SNOMED CT 2011_0131
55149002
Subjects diagnosed with type 2 diabetes and treated with either diet and exercise alone, metformin, SU, glitazone as single agent therapy or any combination of the previously mentioned compounds (metformin+SU, metformin+glitazone, SU+glitazone, metformin+SU+glitazone)
Description

Subjects diagnosed with type 2 diabetes and treated with either diet and exercise alone, metformin, SU, glitazone as single agent therapy or any combination of the previously mentioned compounds (metformin+SU, metformin+glitazone, SU+glitazone, metformin+SU+glitazone)

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0011860
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0012155
SNOMED CT 2011_0131
41829006
UMLS CUI 2011AA
C0015259
SNOMED CT 2011_0131
256235009
MedDRA 14.1
10015634
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C0038766
UMLS CUI 2011AA
C1257987
SNOMED CT 2011_0131
109086001
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C1254351
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0556895
SNOMED CT 2011_0131
229554006
Hemoglobin A1c (HbA1c)
Description

Glycosylated haemoglobin (HbA1c) 7.0-10.0% (both inclusive)

Data type

boolean

Alias
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
Body mass index
Description

Body Mass Index (BMI) of 27.0 kg/m^2

Data type

boolean

Alias
UMLS CUI 2011AA
C1305855
SNOMED CT 2011_0131
140075008
MedDRA 14.1
10005894
LOINC Version 232
LP35925-4
Stable body weight
Description

Stable body weight

Data type

boolean

Alias
UMLS CUI 2011AA
C0005910
Preceding failed dietary effort
Description

Preceding failed dietary effort

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0231175
UMLS CUI 2011AA
C0012155
SNOMED CT 2011_0131
41829006
UMLS CUI 2011AA
CL384237
Exclusion Criteria
Description

Exclusion Criteria

Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months
Description

Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C2917359
UMLS CUI 2011AA
C1827106
SNOMED CT 2011_0131
423837000
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
Known proliferative retinopathy or maculopathy
Description

Known proliferative retinopathy or maculopathy

Data type

boolean

Alias
UMLS CUI 2011AA
C0339467
MedDRA 14.1
10038934
UMLS CUI 2011AA
C1514485
UMLS CUI 2011AA
C0730362
SNOMED CT 2011_0131
312999006
MedDRA 14.1
10025425
History of acute or chronic pancreatitis
Description

History of acute or chronic pancreatitis

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0001339
SNOMED CT 2011_0131
197456007
MedDRA 14.1
10033647
ICD-10-CM Version 2010
K85.9
ICD-9-CM Version 2011
577.0
UMLS CUI 2011AA
C0149521
SNOMED CT 2011_0131
235494005
MedDRA 14.1
10033649
ICD-10-CM Version 2010
K86.1
ICD-9-CM Version 2011
577.1
Obesity induced by drug treatment
Description

Obesity induced by drug treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0348956
Use of approved weight lowering pharmacotherapy
Description

Use of approved weight lowering pharmacotherapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0205540
SNOMED CT 2011_0131
9571008
UMLS CUI 2011AA
C0005910
SNOMED CT 2011_0131
27113001
LOINC Version 232
MTHU001885
UMLS CUI 2011AA
C2003888
UMLS CUI 2011AA
C0013216
SNOMED CT 2011_0131
416608005
MedDRA 14.1
10063370
LOINC Version 232
MTHU010425
HL7 V3 2006_05
DRUG
Previous surgical treatment of obesity
Description

Previous surgical treatment of obesity

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1167841
MedDRA 14.1
10059610
History of major depressive disorder or suicide attempt
Description

History of major depressive disorder or suicide attempt

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C1269683
SNOMED CT 2011_0131
370143000
MedDRA 14.1
10057840
ICD-10-CM Version 2010
F32.9
UMLS CUI 2011AA
C2911479
ICD-10-CM Version 2010
Z91.5
Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)
Description

Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)

Data type

boolean

Alias
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
UMLS CUI 2011AA
C0871470
SNOMED CT 2011_0131
271649006
UMLS CUI 2011AA
C0428883
SNOMED CT 2011_0131
271650006
Screening calcitonin of 50 ng/L or above
Description

Screening calcitonin of 50 ng/L or above

Data type

boolean

Alias
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0006668
SNOMED CT 2011_0131
63730009
LOINC Version 232
MTHU003443
Familial or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
Description

Familial or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0025268
SNOMED CT 2011_0131
61808009
MedDRA 14.1
10028191
ICD-10-CM Version 2010
E31.22
ICD-9-CM Version 2011
258.02
UMLS CUI 2011AA
C0025269
SNOMED CT 2011_0131
61530001
MedDRA 14.1
10056420
UMLS CUI 2011AA
C1833921
Personal history of non-familial medullary thyroid carcinoma
Description

Personal history of non-familial medullary thyroid carcinoma

Data type

boolean

Alias
UMLS CUI 2011AA
C1997422
SNOMED CT 2011_0131
429016002
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0241888
SNOMED CT 2011_0131
255401001
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Informed consent obtained
Item
Procurement of patient informed consent, investigational study
boolean
C0021430 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
Subjects diagnosed with type 2 diabetes and treated with either diet and exercise alone, metformin, SU, glitazone as single agent therapy or any combination of the previously mentioned compounds (metformin+SU, metformin+glitazone, SU+glitazone, metformin+SU+glitazone)
Item
Subjects diagnosed with type 2 diabetes and treated with either diet and exercise alone, metformin, SU, glitazone as single agent therapy or any combination of the previously mentioned compounds (metformin+SU, metformin+glitazone, SU+glitazone, metformin+SU+glitazone)
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
CL415147 (UMLS CUI 2011AA)
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C0038766 (UMLS CUI 2011AA)
C1257987 (UMLS CUI 2011AA)
109086001 (SNOMED CT 2011_0131)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C1254351 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0556895 (UMLS CUI 2011AA)
229554006 (SNOMED CT 2011_0131)
Glycosylated haemoglobin (HbA1c) 7.0-10.0% (both inclusive)
Item
Hemoglobin A1c (HbA1c)
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
Body Mass Index (BMI) of 27.0 kg/m^2
Item
Body mass index
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
Stable body weight
Item
Stable body weight
boolean
C0005910 (UMLS CUI 2011AA)
Preceding failed dietary effort
Item
Preceding failed dietary effort
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0231175 (UMLS CUI 2011AA)
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
CL384237 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months
Item
Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months
boolean
C0039798 (UMLS CUI 2011AA)
C2917359 (UMLS CUI 2011AA)
C1827106 (UMLS CUI 2011AA)
423837000 (SNOMED CT 2011_0131)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
Known proliferative retinopathy or maculopathy
Item
Known proliferative retinopathy or maculopathy
boolean
C0339467 (UMLS CUI 2011AA)
10038934 (MedDRA 14.1)
C1514485 (UMLS CUI 2011AA)
C0730362 (UMLS CUI 2011AA)
312999006 (SNOMED CT 2011_0131)
10025425 (MedDRA 14.1)
History of acute or chronic pancreatitis
Item
History of acute or chronic pancreatitis
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0001339 (UMLS CUI 2011AA)
197456007 (SNOMED CT 2011_0131)
10033647 (MedDRA 14.1)
K85.9 (ICD-10-CM Version 2010)
577.0 (ICD-9-CM Version 2011)
C0149521 (UMLS CUI 2011AA)
235494005 (SNOMED CT 2011_0131)
10033649 (MedDRA 14.1)
K86.1 (ICD-10-CM Version 2010)
577.1 (ICD-9-CM Version 2011)
Obesity induced by drug treatment
Item
Obesity induced by drug treatment
boolean
C0348956 (UMLS CUI 2011AA)
Use of approved weight lowering pharmacotherapy
Item
Use of approved weight lowering pharmacotherapy
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0205540 (UMLS CUI 2011AA)
9571008 (SNOMED CT 2011_0131)
C0005910 (UMLS CUI 2011AA)
27113001 (SNOMED CT 2011_0131)
MTHU001885 (LOINC Version 232)
C2003888 (UMLS CUI 2011AA)
C0013216 (UMLS CUI 2011AA)
416608005 (SNOMED CT 2011_0131)
10063370 (MedDRA 14.1)
MTHU010425 (LOINC Version 232)
DRUG (HL7 V3 2006_05)
Previous surgical treatment of obesity
Item
Previous surgical treatment of obesity
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1167841 (UMLS CUI 2011AA)
10059610 (MedDRA 14.1)
History of major depressive disorder or suicide attempt
Item
History of major depressive disorder or suicide attempt
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1269683 (UMLS CUI 2011AA)
370143000 (SNOMED CT 2011_0131)
10057840 (MedDRA 14.1)
F32.9 (ICD-10-CM Version 2010)
C2911479 (UMLS CUI 2011AA)
Z91.5 (ICD-10-CM Version 2010)
Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)
Item
Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)
boolean
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
C0871470 (UMLS CUI 2011AA)
271649006 (SNOMED CT 2011_0131)
C0428883 (UMLS CUI 2011AA)
271650006 (SNOMED CT 2011_0131)
Screening calcitonin of 50 ng/L or above
Item
Screening calcitonin of 50 ng/L or above
boolean
C1409616 (UMLS CUI 2011AA)
C0006668 (UMLS CUI 2011AA)
63730009 (SNOMED CT 2011_0131)
MTHU003443 (LOINC Version 232)
Familial or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
Item
Familial or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0025268 (UMLS CUI 2011AA)
61808009 (SNOMED CT 2011_0131)
10028191 (MedDRA 14.1)
E31.22 (ICD-10-CM Version 2010)
258.02 (ICD-9-CM Version 2011)
C0025269 (UMLS CUI 2011AA)
61530001 (SNOMED CT 2011_0131)
10056420 (MedDRA 14.1)
C1833921 (UMLS CUI 2011AA)
Personal history of non-familial medullary thyroid carcinoma
Item
Personal history of non-familial medullary thyroid carcinoma
boolean
C1997422 (UMLS CUI 2011AA)
429016002 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0241888 (UMLS CUI 2011AA)
255401001 (SNOMED CT 2011_0131)
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