ID

29817

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00641251

Nyckelord

  1. 2018-04-21 2018-04-21 - Julian Varghese
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

21 april 2018

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes NCT00641251

Eligibility Type 2 Diabetes NCT00641251

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 30 to 67 years at eligibility visit.
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
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 %.
Beskrivning

diabetes mellitus type 2; hba1c

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0019018
body mass index (bmi) ≥ 30.0 kg/m2 and ≤ 39.9 kg/m2 at eligibility visit.
Beskrivning

bmi

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
willingness to accept random assignment to either treatment group.
Beskrivning

Compliance behavior

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
expect to live or work within approximately one hour's traveling time from the study clinic for the duration of the two-year trial.
Beskrivning

Residence status

Datatyp

boolean

Alias
UMLS CUI [1]
C0946341
willingness to comply with the follow-up protocol and successful completion of the run-in (described below).
Beskrivning

Compliance behavior

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
written informed consent.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
Beskrivning

cardiovascular disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
Beskrivning

congestive heart failure; Peripheral Vascular Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0085096
cardiac stress test indicating that surgery or imm would not be safe.
Beskrivning

cardiac stress

Datatyp

boolean

Alias
UMLS CUI [1]
C2317276
pulmonary embolus or thrombophlebitis in the past six months.
Beskrivning

pulmonary embolus; thrombophlebitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0034065
UMLS CUI [2]
C0040046
cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.
Beskrivning

malignant neoplasm

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
significant anemia (hemoglobin 1.0 g or more below normal range) or history of coagulopathy.
Beskrivning

anemia; coagulopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0005779
serum creatinine ≥ 1.5 mg/dl.
Beskrivning

serum creatinine

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
hba1c > 14.0%.
Beskrivning

hba1c

Datatyp

boolean

Alias
UMLS CUI [1]
C0019018

Similar models

Eligibility Type 2 Diabetes NCT00641251

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])

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