ID

22103

Beschreibung

Study In Patients With Type 2 Diabetes Who Are Taking Metformin And Sulfonylurea, Metformin And Insulin, Or Insulin; ODM derived from: https://clinicaltrials.gov/show/NCT00269061

Link

https://clinicaltrials.gov/show/NCT00269061

Stichworte

Versionen (2)
  1. 19.05.17 19.05.17 -
  2. 19.05.17 19.05.17 -
Hochgeladen am

19. Mai 2017

DOI

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Creative Commons BY 4.0
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Eligibility Non-Insulin-Dependent Diabetes Mellitus NCT00269061

Englisch

Eligibility Non-Insulin-Dependent Diabetes Mellitus NCT00269061

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have been diagnosed with type 2 diabetes at least three months prior to screening.
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
must be taking either metformin and a sulfonylurea, metformin and insulin, or insulin only, and doses of these medications must have been stable for at least three months.
Beschreibung

Metformin Dose Stable | Sulfonylurea Dose Stable | Insulin Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0038766
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0021641
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
must have a body mass index (bmi) of between 24 and 35.
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
if female, the subject must be post-menopausal.
Beschreibung

Postmenopausal state

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
hba1c levels must be between 7% and 10%.
Beschreibung

Glucohemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202054
subjects must be eligible for mri scanning (ie, no metal implants, pacemaker, etc).
Beschreibung

Patient eligible Magnetic Resonance Imaging | Implants Metallic Absent | Artificial cardiac pacemaker Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0024485
UMLS CUI [2,1]
C0021102
UMLS CUI [2,2]
C2986473
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0030163
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
suffer from claustrophobia.
Beschreibung

Claustrophobia

Datentyp

boolean

Alias
UMLS CUI [1]
C0008909
use of tobacco, nicotine, or illegal drugs of abuse.
Beschreibung

Tobacco use | DRUG ABUSE ILLICIT

Datentyp

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C0743253
use of caffeine within two days prior to each study visit.
Beschreibung

caffeine use

Datentyp

boolean

Alias
UMLS CUI [1]
C2006086
hiv, hepatitis, edema, untreated blood pressure problems, heart, lung, nervous system or kidney disease, history of blood clots in the legs, diabetic neuropathy, or untreated thyroid disease.
Beschreibung

HIV Infection | Hepatitis | Edema | Blood pressure problem untreated | Heart Disease | Lung disease | nervous system disorder | Kidney Disease | Blood Clot Lower Extremity | Diabetic Neuropathy | Thyroid Disease untreated

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019158
UMLS CUI [3]
C0013604
UMLS CUI [4,1]
C0848910
UMLS CUI [4,2]
C0332155
UMLS CUI [5]
C0018799
UMLS CUI [6]
C0024115
UMLS CUI [7]
C0027765
UMLS CUI [8]
C0022658
UMLS CUI [9,1]
C0302148
UMLS CUI [9,2]
C0023216
UMLS CUI [10]
C0011882
UMLS CUI [11,1]
C0040128
UMLS CUI [11,2]
C0332155
use of drugs or medications that affect the levels of fluid in the body, such as diuretics.
Beschreibung

Pharmaceutical Preparations Affecting Body Fluid Level | Diuretics

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005889
UMLS CUI [1,4]
C0441889
UMLS CUI [2]
C0012798
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Ähnliche Modelle

Eligibility Non-Insulin-Dependent Diabetes Mellitus NCT00269061

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
must have been diagnosed with type 2 diabetes at least three months prior to screening.
boolean
C0011860 (UMLS CUI [1])
Metformin Dose Stable | Sulfonylurea Dose Stable | Insulin Dose Stable
Item
must be taking either metformin and a sulfonylurea, metformin and insulin, or insulin only, and doses of these medications must have been stable for at least three months.
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0021641 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Body mass index
Item
must have a body mass index (bmi) of between 24 and 35.
boolean
C1305855 (UMLS CUI [1])
Postmenopausal state
Item
if female, the subject must be post-menopausal.
boolean
C0232970 (UMLS CUI [1])
Glucohemoglobin measurement
Item
hba1c levels must be between 7% and 10%.
boolean
C0202054 (UMLS CUI [1])
Patient eligible Magnetic Resonance Imaging | Implants Metallic Absent | Artificial cardiac pacemaker Absent
Item
subjects must be eligible for mri scanning (ie, no metal implants, pacemaker, etc).
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0021102 (UMLS CUI [2,1])
C2986473 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0030163 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Claustrophobia
Item
suffer from claustrophobia.
boolean
C0008909 (UMLS CUI [1])
Tobacco use | DRUG ABUSE ILLICIT
Item
use of tobacco, nicotine, or illegal drugs of abuse.
boolean
C0543414 (UMLS CUI [1])
C0743253 (UMLS CUI [2])
caffeine use
Item
use of caffeine within two days prior to each study visit.
boolean
C2006086 (UMLS CUI [1])
HIV Infection | Hepatitis | Edema | Blood pressure problem untreated | Heart Disease | Lung disease | nervous system disorder | Kidney Disease | Blood Clot Lower Extremity | Diabetic Neuropathy | Thyroid Disease untreated
Item
hiv, hepatitis, edema, untreated blood pressure problems, heart, lung, nervous system or kidney disease, history of blood clots in the legs, diabetic neuropathy, or untreated thyroid disease.
boolean
C0019693 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
C0013604 (UMLS CUI [3])
C0848910 (UMLS CUI [4,1])
C0332155 (UMLS CUI [4,2])
C0018799 (UMLS CUI [5])
C0024115 (UMLS CUI [6])
C0027765 (UMLS CUI [7])
C0022658 (UMLS CUI [8])
C0302148 (UMLS CUI [9,1])
C0023216 (UMLS CUI [9,2])
C0011882 (UMLS CUI [10])
C0040128 (UMLS CUI [11,1])
C0332155 (UMLS CUI [11,2])
Pharmaceutical Preparations Affecting Body Fluid Level | Diuretics
Item
use of drugs or medications that affect the levels of fluid in the body, such as diuretics.
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005889 (UMLS CUI [1,3])
C0441889 (UMLS CUI [1,4])
C0012798 (UMLS CUI [2])
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