ID

32948

Description

The TRIABETES Study: A Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01047735

Link

https://clinicaltrials.gov/show/NCT01047735

Keywords

Versions (1)
  1. 11/21/18 11/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 21, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT01047735

English

Eligibility Type 2 Diabetes Mellitus NCT01047735

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 25 to 55 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
mild to moderate obesity with a bmi between 30 and 40 kg/m2
Description

Obesity Mild | Moderate obesity | Body mass index

Data type

boolean

Alias
UMLS CUI [1,1]
C0028754
UMLS CUI [1,2]
C2945599
UMLS CUI [2]
C0694533
UMLS CUI [3]
C1305855
for potential subjects with bmi 35 to 40 kg/m2: t2dm confirmed by either a documented fasting blood glucose > 126 mg/dl or treatment with an anti-diabetic medication
Description

Body mass index | Diabetes Mellitus, Non-Insulin-Dependent | Fasting blood glucose measurement | Antidiabetics

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0428568
UMLS CUI [4]
C0935929
for potential subjects with bmi 30 to 35 kg/m2: t2dm that is difficult to control medically and is recommended for the study by the subject's endocrinologist and treatment with an anti-diabetic medication
Description

Body mass index | Non-Insulin-Dependent Diabetes Mellitus CONTROL DIFFICULT | Antidiabetics

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0742800
UMLS CUI [3]
C0935929
willingness to be randomized to a surgical intervention
Description

Randomization Surgical intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0549433
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior bariatric or foregut surgery
Description

Bariatric Surgery | Foregut Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C1456587
UMLS CUI [2,1]
C1521980
UMLS CUI [2,2]
C0543467
poor overall general health
Description

General health poor

Data type

boolean

Alias
UMLS CUI [1]
C1277248
impaired mental status
Description

Mental state Impaired

Data type

boolean

Alias
UMLS CUI [1,1]
C0278060
UMLS CUI [1,2]
C0221099
drug and/or alcohol addiction
Description

Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
current smoking
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
pregnant or plans to become pregnant
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
type 1 diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
portal hypertension and/or cirrhosis
Description

Hypertension, Portal | Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0020541
UMLS CUI [2]
C0023890
failed study-related nutrition or psychological assessment
Description

Nutrition Study Protocol Related failed | Psychological assessment failed

Data type

boolean

Alias
UMLS CUI [1,1]
C1442959
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0439849
UMLS CUI [1,4]
C0231175
UMLS CUI [2,1]
C0204452
UMLS CUI [2,2]
C0231175
current participation in any other research study
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
inability to provide informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
unlikely to comply with study protocol
Description

Protocol Compliance Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558
unable to communicate with study staff
Description

Lacking Able to communicate Research Personnel

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2364293
UMLS CUI [1,3]
C0035173
unable to exercise (walk a city block or a flight of stairs)
Description

Exercise Unable | Lacking Able to walk City Block | Walking up a flight of stairs Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0015259
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C2712089
UMLS CUI [2,3]
C1706084
UMLS CUI [3,1]
C3843052
UMLS CUI [3,2]
C1299582
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT01047735

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 25 to 55 years
boolean
C0001779 (UMLS CUI [1])
Obesity Mild | Moderate obesity | Body mass index
Item
mild to moderate obesity with a bmi between 30 and 40 kg/m2
boolean
C0028754 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C0694533 (UMLS CUI [2])
C1305855 (UMLS CUI [3])
Body mass index | Diabetes Mellitus, Non-Insulin-Dependent | Fasting blood glucose measurement | Antidiabetics
Item
for potential subjects with bmi 35 to 40 kg/m2: t2dm confirmed by either a documented fasting blood glucose > 126 mg/dl or treatment with an anti-diabetic medication
boolean
C1305855 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0428568 (UMLS CUI [3])
C0935929 (UMLS CUI [4])
Body mass index | Non-Insulin-Dependent Diabetes Mellitus CONTROL DIFFICULT | Antidiabetics
Item
for potential subjects with bmi 30 to 35 kg/m2: t2dm that is difficult to control medically and is recommended for the study by the subject's endocrinologist and treatment with an anti-diabetic medication
boolean
C1305855 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C0742800 (UMLS CUI [2,2])
C0935929 (UMLS CUI [3])
Randomization Surgical intervention
Item
willingness to be randomized to a surgical intervention
boolean
C0034656 (UMLS CUI [1,1])
C0549433 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Bariatric Surgery | Foregut Operative Surgical Procedures
Item
prior bariatric or foregut surgery
boolean
C1456587 (UMLS CUI [1])
C1521980 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
General health poor
Item
poor overall general health
boolean
C1277248 (UMLS CUI [1])
Mental state Impaired
Item
impaired mental status
boolean
C0278060 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
Substance Dependence
Item
drug and/or alcohol addiction
boolean
C0038580 (UMLS CUI [1])
Tobacco use
Item
current smoking
boolean
C0543414 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned
Item
pregnant or plans to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Hypertension, Portal | Liver Cirrhosis
Item
portal hypertension and/or cirrhosis
boolean
C0020541 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
Nutrition Study Protocol Related failed | Psychological assessment failed
Item
failed study-related nutrition or psychological assessment
boolean
C1442959 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C0204452 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Study Subject Participation Status
Item
current participation in any other research study
boolean
C2348568 (UMLS CUI [1])
Informed Consent Unable
Item
inability to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Protocol Compliance Unlikely
Item
unlikely to comply with study protocol
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
Lacking Able to communicate Research Personnel
Item
unable to communicate with study staff
boolean
C0332268 (UMLS CUI [1,1])
C2364293 (UMLS CUI [1,2])
C0035173 (UMLS CUI [1,3])
Exercise Unable | Lacking Able to walk City Block | Walking up a flight of stairs Unable
Item
unable to exercise (walk a city block or a flight of stairs)
boolean
C0015259 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0332268 (UMLS CUI [2,1])
C2712089 (UMLS CUI [2,2])
C1706084 (UMLS CUI [2,3])
C3843052 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
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