Eligibility Type 2 Diabetes Mellitus NCT01047735

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StudyEvent: Eligibility
1. Eligibility Type 2 Diabetes Mellitus NCT01047735

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

Inclusion Criteria

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])

Exclusion Criteria

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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Eligibility Type 2 Diabetes Mellitus NCT01047735