ID

40448

Beskrivning

Endothelial Function in Patients With Type 2 Diabetes Versus Healthy Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01946347

Länk

https://clinicaltrials.gov/show/NCT01946347

Nyckelord

Versioner (1)
  1. 2020-04-22 2020-04-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 april 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Insulin Resistance NCT01946347

Engelsk

Eligibility Insulin Resistance NCT01946347

1 Formulär  
Criteria
Beskrivning

Criteria

inclusion criteria -
Beskrivning

Inclusion criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C1512693
1. men and women aged 30-65 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. body mass index in the range of 25 - 45(kg/m2)
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
3. type 2 diabetes mellitus for at least one year
Beskrivning

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
4. treatment of t2d: diet or oral antidiabetic agents (stable drug therapy at least 3 months before the trial
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Antidiabetics Oral | Pharmacotherapy Stable

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0012159
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [4,1]
C0013216
UMLS CUI [4,2]
C0205360
5. the presence of metabolic syndrome - any three of the following symptoms:
Beskrivning

Metabolic Syndrome | Symptoms Quantity Any

Datatyp

boolean

Alias
UMLS CUI [1]
C0524620
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1552551
1. abdominal obesity - waist circumference in men >102 cm, in women >88 cm
Beskrivning

Obesity, Abdominal | Waist Circumference | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0311277
UMLS CUI [2]
C0455829
UMLS CUI [3]
C0079399
2. diagnosis and treatment of type 2 diabetes
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent | Therapy Non-Insulin-Dependent Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0011860
3. raised blood pressure (bp): systolic bp > 130 mm hg or diastolic bp >85 mm hg, or treatment of previously diagnosed hypertension
Beskrivning

Increase in blood pressure | Systolic Pressure | Diastolic blood pressure | Therapy Hypertensive disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0497247
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0020538
4. reduced hdl cholesterol in men < 1 mmol/l, in women < 1,3 mmol/l (or treatment)
Beskrivning

Decreased HDL cholesterol | Gender | Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0151691
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0087111
5. raised triglycerides > 1,7 mmol/l (or treatment)
Beskrivning

Raised triglycerides | Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0020557
UMLS CUI [2]
C0087111
4. hba1c ≥ 42 a ≤100 mmol/mol
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
exclusion criteria -
Beskrivning

Exclusion Criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
1. type 1 diabetes mellitus
Beskrivning

Diabetes Mellitus, Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
2. unstable drug therapy at least 3 month before the trial
Beskrivning

Pharmacotherapy Unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0443343
3. pregnancy, breast feeding or trying to become pregnant
Beskrivning

Pregnancy | Breast Feeding | Trying to conceive

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0420843
4. alcoholism or drug use
Beskrivning

Alcoholic Intoxication, Chronic | Drug Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0013222
5. presence of other medical condition, which occurs during physical examination, laboratory tests, including pulmonary, neurological or inflammatory disease, which would be considered by the examiner to distort the consistency of data
Beskrivning

Other medical condition Interferes with Research data | Physical Examination | Laboratory Procedures | Lung disease | Nervous system disorder | Inflammatory disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0681873
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0022885
UMLS CUI [4]
C0024115
UMLS CUI [5]
C0027765
UMLS CUI [6]
C1290884
healthy subjects:
Beskrivning

Healthy Volunteers

Datatyp

boolean

Alias
UMLS CUI [1]
C1708335
inclusion criteria -
Beskrivning

Inclusion criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C1512693
1. men and women aged 30-65 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. body mass index 25-45 (kg/m2)
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
3. absence of metabolic syndrome - not more than any two of the following symptoms:
Beskrivning

Metabolic Syndrome Absent | Symptoms Quantity Any

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524620
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1552551
1. abdominal obesity - waist circumference in men >102 cm, in women >88 cm
Beskrivning

Obesity, Abdominal | Waist Circumference | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0311277
UMLS CUI [2]
C0455829
UMLS CUI [3]
C0079399
2. diagnosis and treatment of type 2 diabetes or raised fasting plasma glucose level (fpg >5,6 mmol/l)
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent | Therapy Non-Insulin-Dependent Diabetes Mellitus | Elevated fasting plasma glucose

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0011860
UMLS CUI [3]
C4228506
3. raised blood pressure (bp): systolic bp >130 mm hg or diastolic bp >85 mm hg, or treatment of previously diagnosed hypertension
Beskrivning

Increase in blood pressure | Systolic Pressure | Diastolic blood pressure | Therapy Hypertensive disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0497247
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0020538
4. reduced hdl cholesterol in men <1 mmol/l, in women <1,3 mmol/l(or treatment)
Beskrivning

Decreased HDL cholesterol | Gender | Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0151691
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0087111
5. raised triglycerides > 1,7 mmol/l (or treatment)
Beskrivning

Raised triglycerides | Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0020557
UMLS CUI [2]
C0087111
exclusion criteria -
Beskrivning

Exclusion Criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
1. diabetes or impaired glucose tolerance (hba1c ≥40 mmol/mol and/or fpg >5,6 mmol/l), diagnosed diabetes in first-line relatives
Beskrivning

Diabetes Mellitus | Decreased glucose tolerance | Hemoglobin A1c measurement | Plasma fasting glucose measurement | Diabetes Mellitus First Degree Relative

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0151671
UMLS CUI [3]
C0474680
UMLS CUI [4]
C0583513
UMLS CUI [5,1]
C0011849
UMLS CUI [5,2]
C1517194
2. pregnancy, breast feeding or trying to become pregnant
Beskrivning

Pregnancy | Breast Feeding | Trying to conceive

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0420843
3. alcoholism or drug use
Beskrivning

Alcoholic Intoxication, Chronic | Drug Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0013222
4. presence of other medical condition, which occurs during physical examination, laboratory tests, including pulmonary, neurological or inflammatory disease, which would be considered by the examiner to distort the consistency of data
Beskrivning

Other medical condition Interferes with Research data | Physical Examination | Laboratory Procedures | Lung disease | Nervous system disorder | Inflammatory disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0681873
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0022885
UMLS CUI [4]
C0024115
UMLS CUI [5]
C0027765
UMLS CUI [6]
C1290884
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Similar models

Eligibility Insulin Resistance NCT01946347

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion criteria
Item
inclusion criteria -
boolean
C1512693 (UMLS CUI [1])
Age
Item
1. men and women aged 30-65 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
2. body mass index in the range of 25 - 45(kg/m2)
boolean
C1305855 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
3. type 2 diabetes mellitus for at least one year
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Antidiabetics Oral | Pharmacotherapy Stable
Item
4. treatment of t2d: diet or oral antidiabetic agents (stable drug therapy at least 3 months before the trial
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0013216 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
Metabolic Syndrome | Symptoms Quantity Any
Item
5. the presence of metabolic syndrome - any three of the following symptoms:
boolean
C0524620 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
Obesity, Abdominal | Waist Circumference | Gender
Item
1. abdominal obesity - waist circumference in men >102 cm, in women >88 cm
boolean
C0311277 (UMLS CUI [1])
C0455829 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Diabetes Mellitus, Non-Insulin-Dependent | Therapy Non-Insulin-Dependent Diabetes Mellitus
Item
2. diagnosis and treatment of type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
Increase in blood pressure | Systolic Pressure | Diastolic blood pressure | Therapy Hypertensive disease
Item
3. raised blood pressure (bp): systolic bp > 130 mm hg or diastolic bp >85 mm hg, or treatment of previously diagnosed hypertension
boolean
C0497247 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0020538 (UMLS CUI [4,2])
Decreased HDL cholesterol | Gender | Therapy
Item
4. reduced hdl cholesterol in men < 1 mmol/l, in women < 1,3 mmol/l (or treatment)
boolean
C0151691 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0087111 (UMLS CUI [3])
Raised triglycerides | Therapy
Item
5. raised triglycerides > 1,7 mmol/l (or treatment)
boolean
C0020557 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
Hemoglobin A1c measurement
Item
4. hba1c ≥ 42 a ≤100 mmol/mol
boolean
C0474680 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion criteria -
boolean
C0680251 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
1. type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Pharmacotherapy Unstable
Item
2. unstable drug therapy at least 3 month before the trial
boolean
C0013216 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Trying to conceive
Item
3. pregnancy, breast feeding or trying to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0420843 (UMLS CUI [3])
Alcoholic Intoxication, Chronic | Drug Use Disorders
Item
4. alcoholism or drug use
boolean
C0001973 (UMLS CUI [1])
C0013222 (UMLS CUI [2])
Other medical condition Interferes with Research data | Physical Examination | Laboratory Procedures | Lung disease | Nervous system disorder | Inflammatory disorder
Item
5. presence of other medical condition, which occurs during physical examination, laboratory tests, including pulmonary, neurological or inflammatory disease, which would be considered by the examiner to distort the consistency of data
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0681873 (UMLS CUI [1,3])
C0031809 (UMLS CUI [2])
C0022885 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C1290884 (UMLS CUI [6])
Healthy Volunteers
Item
healthy subjects:
boolean
C1708335 (UMLS CUI [1])
Inclusion criteria
Item
inclusion criteria -
boolean
C1512693 (UMLS CUI [1])
Age
Item
1. men and women aged 30-65 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
2. body mass index 25-45 (kg/m2)
boolean
C1305855 (UMLS CUI [1])
Metabolic Syndrome Absent | Symptoms Quantity Any
Item
3. absence of metabolic syndrome - not more than any two of the following symptoms:
boolean
C0524620 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
Obesity, Abdominal | Waist Circumference | Gender
Item
1. abdominal obesity - waist circumference in men >102 cm, in women >88 cm
boolean
C0311277 (UMLS CUI [1])
C0455829 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Diabetes Mellitus, Non-Insulin-Dependent | Therapy Non-Insulin-Dependent Diabetes Mellitus | Elevated fasting plasma glucose
Item
2. diagnosis and treatment of type 2 diabetes or raised fasting plasma glucose level (fpg >5,6 mmol/l)
boolean
C0011860 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
C4228506 (UMLS CUI [3])
Increase in blood pressure | Systolic Pressure | Diastolic blood pressure | Therapy Hypertensive disease
Item
3. raised blood pressure (bp): systolic bp >130 mm hg or diastolic bp >85 mm hg, or treatment of previously diagnosed hypertension
boolean
C0497247 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0020538 (UMLS CUI [4,2])
Decreased HDL cholesterol | Gender | Therapy
Item
4. reduced hdl cholesterol in men <1 mmol/l, in women <1,3 mmol/l(or treatment)
boolean
C0151691 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0087111 (UMLS CUI [3])
Raised triglycerides | Therapy
Item
5. raised triglycerides > 1,7 mmol/l (or treatment)
boolean
C0020557 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
Exclusion Criteria
Item
exclusion criteria -
boolean
C0680251 (UMLS CUI [1])
Diabetes Mellitus | Decreased glucose tolerance | Hemoglobin A1c measurement | Plasma fasting glucose measurement | Diabetes Mellitus First Degree Relative
Item
1. diabetes or impaired glucose tolerance (hba1c ≥40 mmol/mol and/or fpg >5,6 mmol/l), diagnosed diabetes in first-line relatives
boolean
C0011849 (UMLS CUI [1])
C0151671 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
C0583513 (UMLS CUI [4])
C0011849 (UMLS CUI [5,1])
C1517194 (UMLS CUI [5,2])
Pregnancy | Breast Feeding | Trying to conceive
Item
2. pregnancy, breast feeding or trying to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0420843 (UMLS CUI [3])
Alcoholic Intoxication, Chronic | Drug Use Disorders
Item
3. alcoholism or drug use
boolean
C0001973 (UMLS CUI [1])
C0013222 (UMLS CUI [2])
Other medical condition Interferes with Research data | Physical Examination | Laboratory Procedures | Lung disease | Nervous system disorder | Inflammatory disorder
Item
4. presence of other medical condition, which occurs during physical examination, laboratory tests, including pulmonary, neurological or inflammatory disease, which would be considered by the examiner to distort the consistency of data
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0681873 (UMLS CUI [1,3])
C0031809 (UMLS CUI [2])
C0022885 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C1290884 (UMLS CUI [6])
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