ID

37401

Beschreibung

Processed Meat and Brain Regions Related to Reward and Addiction; ODM derived from: https://clinicaltrials.gov/show/NCT02474147

Link

https://clinicaltrials.gov/show/NCT02474147

Stichworte

Versionen (1)
  1. 23.07.19 23.07.19 -
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See clinicaltrials.gov

Hochgeladen am

23. Juli 2019

DOI

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Eligibility Type 2 Diabetes NCT02474147

Englisch

Eligibility Type 2 Diabetes NCT02474147

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
inclusion criteria for t2d:
Beschreibung

Inclusion criteria Non-Insulin-Dependent Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0011860
1. type 2 diabetes mellitus for at least one year
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datentyp

boolean

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

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
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
3. the presence of metabolic syndrome - any three of the following symptoms:
Beschreibung

Metabolic Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0524620
abdominal obesity - waist circumf. in men> 102 cm, in women > 88 cm
Beschreibung

Obesity, Abdominal | Waist Circumference | Gender

Datentyp

boolean

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

Diagnosis Non-Insulin-Dependent Diabetes Mellitus | Treatment Non-Insulin-Dependent Diabetes Mellitus | Elevated fasting plasma glucose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0011860
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0011860
UMLS CUI [3]
C4228506
raised blood pressure (bp): systolic bp > 130 mm hg or diastolic bp >85 mm hg, or treatment of previously diagnosed hypertension
Beschreibung

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

Datentyp

boolean

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

Decreased HDL cholesterol | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0151691
UMLS CUI [2]
C0079399
raised triglycerides > 1,7 mmol/l (or treatment)
Beschreibung

Serum triglycerides increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0813230
4. hba1c (according to ifcc) ≥4.2 a ≤10.5%
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
5. men and women aged 30-70 years
Beschreibung

Age

Datentyp

boolean

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

Body mass index Range

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1305855
UMLS CUI [1,2]
C1514721
7. the signed informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
exclusion criteria for t2d:
Beschreibung

Exclusion Criteria Non-Insulin-Dependent Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0011860
1. type 1 diabetes mellitus
Beschreibung

Diabetes Mellitus, Insulin-Dependent

Datentyp

boolean

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

Pharmacotherapy Unstable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0443343
3. treatment with byetta or victosa
Beschreibung

Byetta | Victoza

Datentyp

boolean

Alias
UMLS CUI [1]
C1636686
UMLS CUI [2]
C2732208
4. pregnancy (positive β-hcg test), breast feeding or trying to become pregnant
Beschreibung

Pregnancy | Serum pregnancy test (B-HCG) Positive | Breast Feeding | Trying to conceive

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0430060
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0420843
5. presence of pacemaker or other metal implant in the body (mr)
Beschreibung

Artificial cardiac pacemaker | Metallic implant | Magnetic Resonance

Datentyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C3693688
UMLS CUI [3]
C0917874
6. alcoholism or drug use
Beschreibung

Alcoholic Intoxication, Chronic | Drug Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0013222
7. significant weight loss (more than 5% of body weight) in previous 3 months before the screening
Beschreibung

Weight loss Percentage Timespan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0872291
8. presence of other medical condition, which occurs during physical examination, laboratory tests, ecg, including pulmonary, neurological or inflammatory disease, which would be considered by the examiner to distort the consistency of data
Beschreibung

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

Datentyp

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]
C0013798
UMLS CUI [5]
C0024115
UMLS CUI [6]
C0027765
UMLS CUI [7]
C1290884
9. metal in the body (fmri)
Beschreibung

Metal Body | fMRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025552
UMLS CUI [1,2]
C0460148
UMLS CUI [2]
C0376335
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Ähnliche Modelle

Eligibility Type 2 Diabetes NCT02474147

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria Non-Insulin-Dependent Diabetes Mellitus
Item
inclusion criteria for t2d:
boolean
C1512693 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
1. type 2 diabetes mellitus for at least one year
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Treatment Non-Insulin-Dependent Diabetes Mellitus | Diet therapy | Antidiabetics Oral | Pharmacotherapy Stable
Item
2. treatment of t2d: diet or oral antidiabetic agents (stable drug therapy at least 3 month before the trial
boolean
C0087111 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
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
Item
3. the presence of metabolic syndrome - any three of the following symptoms:
boolean
C0524620 (UMLS CUI [1])
Obesity, Abdominal | Waist Circumference | Gender
Item
abdominal obesity - waist circumf. in men> 102 cm, in women > 88 cm
boolean
C0311277 (UMLS CUI [1])
C0455829 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Diagnosis Non-Insulin-Dependent Diabetes Mellitus | Treatment Non-Insulin-Dependent Diabetes Mellitus | Elevated fasting plasma glucose
Item
diagnosis and treatment of type 2 diabetes or raised fasting plasma glucose level (fpg>5,6 mmol/l)
boolean
C0011900 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
C4228506 (UMLS CUI [3])
Increase in blood pressure | Systolic Pressure | Diastolic blood pressure | Treatment Hypertensive disease
Item
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
Item
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])
Serum triglycerides increased
Item
raised triglycerides > 1,7 mmol/l (or treatment)
boolean
C0813230 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
4. hba1c (according to ifcc) ≥4.2 a ≤10.5%
boolean
C0474680 (UMLS CUI [1])
Age
Item
5. men and women aged 30-70 years
boolean
C0001779 (UMLS CUI [1])
Body mass index Range
Item
6. body mass index (kg/m2) in the range of 25- 45
boolean
C1305855 (UMLS CUI [1,1])
C1514721 (UMLS CUI [1,2])
Informed Consent
Item
7. the signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Non-Insulin-Dependent Diabetes Mellitus
Item
exclusion criteria for t2d:
boolean
C0680251 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
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])
Byetta | Victoza
Item
3. treatment with byetta or victosa
boolean
C1636686 (UMLS CUI [1])
C2732208 (UMLS CUI [2])
Pregnancy | Serum pregnancy test (B-HCG) Positive | Breast Feeding | Trying to conceive
Item
4. pregnancy (positive β-hcg test), breast feeding or trying to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0430060 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
C0420843 (UMLS CUI [4])
Artificial cardiac pacemaker | Metallic implant | Magnetic Resonance
Item
5. presence of pacemaker or other metal implant in the body (mr)
boolean
C0030163 (UMLS CUI [1])
C3693688 (UMLS CUI [2])
C0917874 (UMLS CUI [3])
Alcoholic Intoxication, Chronic | Drug Use Disorders
Item
6. alcoholism or drug use
boolean
C0001973 (UMLS CUI [1])
C0013222 (UMLS CUI [2])
Weight loss Percentage Timespan
Item
7. significant weight loss (more than 5% of body weight) in previous 3 months before the screening
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Other medical condition Interferes with Research data | Physical Examination | Laboratory Procedures | ECG | Lung disease | Nervous system disorder | Inflammatory disorder
Item
8. presence of other medical condition, which occurs during physical examination, laboratory tests, ecg, 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])
C0013798 (UMLS CUI [4])
C0024115 (UMLS CUI [5])
C0027765 (UMLS CUI [6])
C1290884 (UMLS CUI [7])
Metal Body | fMRI
Item
9. metal in the body (fmri)
boolean
C0025552 (UMLS CUI [1,1])
C0460148 (UMLS CUI [1,2])
C0376335 (UMLS CUI [2])
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