Eligibility Type 2 Diabetes NCT00641251
DSS: Diabetes Surgery Study - Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00641251

Eligibility Type 2 Diabetes NCT00641251

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age 30 to 67 years at eligibility visit.
boolean
C0001779 (UMLS CUI [1])
diabetes mellitus type 2; hba1c
Item
diagnosed with t2dm at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, and hba1c ≥ 8.0 %.
boolean
C0011860 (UMLS CUI [1])
C0019018 (UMLS CUI [2])
bmi
Item
body mass index (bmi) ≥ 30.0 kg/m2 and ≤ 39.9 kg/m2 at eligibility visit.
boolean
C1305855 (UMLS CUI [1])
Compliance behavior
Item
willingness to accept random assignment to either treatment group.
boolean
C1321605 (UMLS CUI [1])
Residence status
Item
expect to live or work within approximately one hour's traveling time from the study clinic for the duration of the two-year trial.
boolean
C0946341 (UMLS CUI [1])
Compliance behavior
Item
willingness to comply with the follow-up protocol and successful completion of the run-in (described below).
boolean
C1321605 (UMLS CUI [1])
informed consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
cardiovascular disease
Item
cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
boolean
C0007222 (UMLS CUI [1])
congestive heart failure; Peripheral Vascular Diseases
Item
current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
boolean
C0018802 (UMLS CUI [1])
C0085096 (UMLS CUI [2])
cardiac stress
Item
cardiac stress test indicating that surgery or imm would not be safe.
boolean
C2317276 (UMLS CUI [1])
pulmonary embolus; thrombophlebitis
Item
pulmonary embolus or thrombophlebitis in the past six months.
boolean
C0034065 (UMLS CUI [1])
C0040046 (UMLS CUI [2])
malignant neoplasm
Item
cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.
boolean
C0006826 (UMLS CUI [1])
anemia; coagulopathy
Item
significant anemia (hemoglobin 1.0 g or more below normal range) or history of coagulopathy.
boolean
C0002871 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
serum creatinine
Item
serum creatinine ≥ 1.5 mg/dl.
boolean
C0201976 (UMLS CUI [1])
hba1c
Item
hba1c > 14.0%.
boolean
C0019018 (UMLS CUI [1])