ID

29221

Beschreibung

The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00620282

Link

https://clinicaltrials.gov/show/NCT00620282

Stichworte

Versionen (1)
  1. 09.03.18 09.03.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. März 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes NCT00620282

Englisch

Eligibility Diabetes NCT00620282

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00620282
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
diet and lifestyle changes or metformin monotherapy for at least three months
Beschreibung

Diet therapy | Lifestyle change therapy | Metformin

Datentyp

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C2960841
UMLS CUI [3]
C0025598
hba1c (glycosylated haemoglobin) 6.5-9.0% (both inclusive)
Beschreibung

Glucohemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202054
body mass index (bmi) less than or equal to 40 kg/m^2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with insulin (except for short term treatment with insulin in connection with intercurrent illness, at the discretion of the investigator)
Beschreibung

Insulin regime | Exception Insulin regime short-term Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0557978
UMLS CUI [2,3]
C0443303
UMLS CUI [2,4]
C0009488
previous treatment with glucagon-like peptide-1 (glp-1) analogues/mimetics, including treatment in a clinical trial
Beschreibung

GLP-1 Mimetics | Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C3273809
UMLS CUI [2]
C2348568
treatment with any oral hypoglycaemic agents other than metformin in a period of 3 months prior to screening
Beschreibung

Oral hypoglycemic | Exception Metformin

Datentyp

boolean

Alias
UMLS CUI [1]
C0359086
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
current smoker or history of smoking within 6 months prior to screening
Beschreibung

Tobacco use

Datentyp

boolean

Alias
UMLS CUI [1]
C0543414
evidence of overt cardiovascular disease (documented coronary heart disease, class ii-iv congestive heart failure, cerebrovascular disease, or peripheral vascular disease)
Beschreibung

Cardiovascular Diseases | Coronary heart disease | Congestive heart failure New York Heart Association Classification | Cerebrovascular Disorders | Peripheral Vascular Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0010068
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C1275491
UMLS CUI [4]
C0007820
UMLS CUI [5]
C0085096
abnormal, clinically significant exercise stress electrocardiogram (ecg) test, as judged by the investigator
Beschreibung

Exercise stress ECG test Abnormal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1304755
UMLS CUI [1,2]
C0205161
known retinopathy or maculopathy requiring acute treatment, as judged by the investigator
Beschreibung

Retinal Disease Treatment required for | Disorder of macula of retina Treatment required for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035309
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0332121
known autonomic neuropathy, as judged by the investigator
Beschreibung

Autonomic neuropathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0259749
initiation or change (dose or treatment regimen) in concomitant blood pressure-lowering or lipid-lowering medication within 4 weeks prior to screening
Beschreibung

Antihypertensive Agents Initiation | Antihypertensive Agents Dose Change | Antihypertensive Agents Change | Hypoglycemic Agents Initiation | Hypoglycemic Agents Dose Change | Hypoglycemic Agents Change

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1704686
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0392747
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C0392747
UMLS CUI [4,1]
C0020616
UMLS CUI [4,2]
C1704686
UMLS CUI [5,1]
C0020616
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0392747
UMLS CUI [6,1]
C0020616
UMLS CUI [6,2]
C0392747
systolic blood pressure more than or equal to 140 mmhg and/or diastolic blood pressure more than or equal to 90 mmhg
Beschreibung

Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
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Ähnliche Modelle

Eligibility Diabetes NCT00620282

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00620282
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Diet therapy | Lifestyle change therapy | Metformin
Item
diet and lifestyle changes or metformin monotherapy for at least three months
boolean
C0012159 (UMLS CUI [1])
C2960841 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
Glucohemoglobin measurement
Item
hba1c (glycosylated haemoglobin) 6.5-9.0% (both inclusive)
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) less than or equal to 40 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Insulin regime | Exception Insulin regime short-term Comorbidity
Item
previous treatment with insulin (except for short term treatment with insulin in connection with intercurrent illness, at the discretion of the investigator)
boolean
C0557978 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0557978 (UMLS CUI [2,2])
C0443303 (UMLS CUI [2,3])
C0009488 (UMLS CUI [2,4])
GLP-1 Mimetics | Study Subject Participation Status
Item
previous treatment with glucagon-like peptide-1 (glp-1) analogues/mimetics, including treatment in a clinical trial
boolean
C3273809 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Oral hypoglycemic | Exception Metformin
Item
treatment with any oral hypoglycaemic agents other than metformin in a period of 3 months prior to screening
boolean
C0359086 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Tobacco use
Item
current smoker or history of smoking within 6 months prior to screening
boolean
C0543414 (UMLS CUI [1])
Cardiovascular Diseases | Coronary heart disease | Congestive heart failure New York Heart Association Classification | Cerebrovascular Disorders | Peripheral Vascular Diseases
Item
evidence of overt cardiovascular disease (documented coronary heart disease, class ii-iv congestive heart failure, cerebrovascular disease, or peripheral vascular disease)
boolean
C0007222 (UMLS CUI [1])
C0010068 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0007820 (UMLS CUI [4])
C0085096 (UMLS CUI [5])
Exercise stress ECG test Abnormal
Item
abnormal, clinically significant exercise stress electrocardiogram (ecg) test, as judged by the investigator
boolean
C1304755 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Retinal Disease Treatment required for | Disorder of macula of retina Treatment required for
Item
known retinopathy or maculopathy requiring acute treatment, as judged by the investigator
boolean
C0035309 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Autonomic neuropathy
Item
known autonomic neuropathy, as judged by the investigator
boolean
C0259749 (UMLS CUI [1])
Antihypertensive Agents Initiation | Antihypertensive Agents Dose Change | Antihypertensive Agents Change | Hypoglycemic Agents Initiation | Hypoglycemic Agents Dose Change | Hypoglycemic Agents Change
Item
initiation or change (dose or treatment regimen) in concomitant blood pressure-lowering or lipid-lowering medication within 4 weeks prior to screening
boolean
C0003364 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0003364 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0020616 (UMLS CUI [4,1])
C1704686 (UMLS CUI [4,2])
C0020616 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0392747 (UMLS CUI [5,3])
C0020616 (UMLS CUI [6,1])
C0392747 (UMLS CUI [6,2])
Systolic Pressure | Diastolic blood pressure
Item
systolic blood pressure more than or equal to 140 mmhg and/or diastolic blood pressure more than or equal to 90 mmhg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
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