ID

31242

Beskrivning

Lifestyle Intervention Targetting Obesity and Insulin Resistance in Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00755742

Länk

https://clinicaltrials.gov/show/NCT00755742

Nyckelord

Versioner (1)
  1. 2018-08-01 2018-08-01 -
Rättsinnehavare

See clinicaltrials.gov

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1 augusti 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Obesity NCT00755742

Engelsk

Eligibility Obesity NCT00755742

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00755742
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
obese (bmi >/= 30)
Beskrivning

Obesity | Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C0028754
UMLS CUI [2]
C1305855
insulin resistant (homa-ir >/= 2.1)
Beskrivning

Insulin Resistance Homeostasis model assessment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021655
UMLS CUI [1,2]
C1829779
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
genotype 3 patients
Beskrivning

Patients Genotype Number

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0017431
UMLS CUI [1,3]
C0237753
women with ongoing pregnancy or who are breast-feeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with any other other underlying liver disease (viral, alcoholic, druginduced, autoimmune, metabolic, genetic).
Beskrivning

Liver disease | Liver disease Viral | Alcoholic Liver Disease | Liver disease Drug-induced | Autoimmune liver disease | Liver disease Metabolic | Liver disease Genetic

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0521026
UMLS CUI [3]
C0023896
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0458082
UMLS CUI [5]
C0400936
UMLS CUI [6,1]
C0023895
UMLS CUI [6,2]
C0311400
UMLS CUI [7,1]
C0023895
UMLS CUI [7,2]
C0314603
patients currently on antiviral therapy, or who have ceased therapy within 6 months of recruitment to the study.
Beskrivning

Antiviral Therapy | Therapeutic procedure Discontinued

Datatyp

boolean

Alias
UMLS CUI [1]
C0280274
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1444662
patients with other causes for insulin resistance e.g., excess counter-regulatory hormones: glucocorticoids, catecholamines, growth hormone, polycystic ovary syndrome).
Beskrivning

Causes Insulin Resistance | Glucocorticoids | Catecholamines | Growth Hormone | Polycystic Ovary Syndrome

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0021655
UMLS CUI [2]
C0017710
UMLS CUI [3]
C0007412
UMLS CUI [4]
C0037663
UMLS CUI [5]
C0032460
patients on steroids or other drug that affects insulin resistance, which are unable to be stopped for 3 days prior to ir testing.
Beskrivning

Steroids Affecting Insulin Resistance | Pharmaceutical Preparations Affecting Insulin Resistance | Steroids Unable to discontinue | Pharmaceutical Preparations Unable to discontinue

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0021655
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0021655
UMLS CUI [3,1]
C0038317
UMLS CUI [3,2]
C1548265
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C1548265
patients with overt diabetes (based on results of fasting plasma glucose) will be excluded from participation as we are focusing on insulin resistance in the absence of diabetes.
Beskrivning

Diabetes mellitus, overt | Plasma fasting glucose measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0543567
UMLS CUI [2]
C0583513
conditions which preclude a sudden increase in physical activity:
Beskrivning

Condition Excludes Increase Physical activity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0442805
UMLS CUI [1,4]
C0026606
history or other evidence of chronic pulmonary disease associated with functional limitation.
Beskrivning

Chronic lung disease Associated with Functional Limitation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0746102
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C4542603
history of severe cardiac disease (e.g., nyha functional class iii or iv, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases).
Beskrivning

Heart Disease Severe New York Heart Association Classification | Myocardial Infarction | Ventricular Tachycardia Treatment required for | Angina, Unstable | Cardiovascular Diseases

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1275491
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0042514
UMLS CUI [3,2]
C0332121
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0007222
unable to 10000 steps/day eg physical disability, morbid obesity.
Beskrivning

Lacking Able to walk Number of steps per day | Physical disability | Obesity, Morbid

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712089
UMLS CUI [1,3]
C1651669
UMLS CUI [1,4]
C0439505
UMLS CUI [2]
C0520817
UMLS CUI [3]
C0028756
evidence of ongoing substance use (including alcohol consumption >20g/day for men and >10g/day for women) within one year of study recruitment.
Beskrivning

Substance Use Disorders | Alcohol consumption Gram per day | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0439417
UMLS CUI [3]
C0079399
poor veins (inadequate venous access)
Beskrivning

Poor venous access

Datatyp

boolean

Alias
UMLS CUI [1]
C0577866
inability or unwillingness to provide informed consent or abide by study requirements eg severe psychiatric illness, lives remotely, time commitment.
Beskrivning

Informed Consent Unable | Informed Consent Unwilling | Protocol Compliance Unable | Protocol Compliance Unwilling | Mental Disorders, Severe | Living place Remote | Time commitment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C0525058
UMLS CUI [4,2]
C0558080
UMLS CUI [5]
C4046029
UMLS CUI [6,1]
C0337646
UMLS CUI [6,2]
C0205157
UMLS CUI [7,1]
C0040223
UMLS CUI [7,2]
C0870312
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Similar models

Eligibility Obesity NCT00755742

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00755742
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Obesity | Body mass index
Item
obese (bmi >/= 30)
boolean
C0028754 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Insulin Resistance Homeostasis model assessment
Item
insulin resistant (homa-ir >/= 2.1)
boolean
C0021655 (UMLS CUI [1,1])
C1829779 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Patients Genotype Number
Item
genotype 3 patients
boolean
C0030705 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
women with ongoing pregnancy or who are breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Liver disease | Liver disease Viral | Alcoholic Liver Disease | Liver disease Drug-induced | Autoimmune liver disease | Liver disease Metabolic | Liver disease Genetic
Item
patients with any other other underlying liver disease (viral, alcoholic, druginduced, autoimmune, metabolic, genetic).
boolean
C0023895 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0521026 (UMLS CUI [2,2])
C0023896 (UMLS CUI [3])
C0023895 (UMLS CUI [4,1])
C0458082 (UMLS CUI [4,2])
C0400936 (UMLS CUI [5])
C0023895 (UMLS CUI [6,1])
C0311400 (UMLS CUI [6,2])
C0023895 (UMLS CUI [7,1])
C0314603 (UMLS CUI [7,2])
Antiviral Therapy | Therapeutic procedure Discontinued
Item
patients currently on antiviral therapy, or who have ceased therapy within 6 months of recruitment to the study.
boolean
C0280274 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
Causes Insulin Resistance | Glucocorticoids | Catecholamines | Growth Hormone | Polycystic Ovary Syndrome
Item
patients with other causes for insulin resistance e.g., excess counter-regulatory hormones: glucocorticoids, catecholamines, growth hormone, polycystic ovary syndrome).
boolean
C0015127 (UMLS CUI [1,1])
C0021655 (UMLS CUI [1,2])
C0017710 (UMLS CUI [2])
C0007412 (UMLS CUI [3])
C0037663 (UMLS CUI [4])
C0032460 (UMLS CUI [5])
Steroids Affecting Insulin Resistance | Pharmaceutical Preparations Affecting Insulin Resistance | Steroids Unable to discontinue | Pharmaceutical Preparations Unable to discontinue
Item
patients on steroids or other drug that affects insulin resistance, which are unable to be stopped for 3 days prior to ir testing.
boolean
C0038317 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0021655 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0021655 (UMLS CUI [2,3])
C0038317 (UMLS CUI [3,1])
C1548265 (UMLS CUI [3,2])
C0013227 (UMLS CUI [4,1])
C1548265 (UMLS CUI [4,2])
Diabetes mellitus, overt | Plasma fasting glucose measurement
Item
patients with overt diabetes (based on results of fasting plasma glucose) will be excluded from participation as we are focusing on insulin resistance in the absence of diabetes.
boolean
C0543567 (UMLS CUI [1])
C0583513 (UMLS CUI [2])
Condition Excludes Increase Physical activity
Item
conditions which preclude a sudden increase in physical activity:
boolean
C0348080 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0442805 (UMLS CUI [1,3])
C0026606 (UMLS CUI [1,4])
Chronic lung disease Associated with Functional Limitation
Item
history or other evidence of chronic pulmonary disease associated with functional limitation.
boolean
C0746102 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C4542603 (UMLS CUI [1,3])
Heart Disease Severe New York Heart Association Classification | Myocardial Infarction | Ventricular Tachycardia Treatment required for | Angina, Unstable | Cardiovascular Diseases
Item
history of severe cardiac disease (e.g., nyha functional class iii or iv, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases).
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0027051 (UMLS CUI [2])
C0042514 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0007222 (UMLS CUI [5])
Lacking Able to walk Number of steps per day | Physical disability | Obesity, Morbid
Item
unable to 10000 steps/day eg physical disability, morbid obesity.
boolean
C0332268 (UMLS CUI [1,1])
C2712089 (UMLS CUI [1,2])
C1651669 (UMLS CUI [1,3])
C0439505 (UMLS CUI [1,4])
C0520817 (UMLS CUI [2])
C0028756 (UMLS CUI [3])
Substance Use Disorders | Alcohol consumption Gram per day | Gender
Item
evidence of ongoing substance use (including alcohol consumption >20g/day for men and >10g/day for women) within one year of study recruitment.
boolean
C0038586 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0439417 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3])
Poor venous access
Item
poor veins (inadequate venous access)
boolean
C0577866 (UMLS CUI [1])
Informed Consent Unable | Informed Consent Unwilling | Protocol Compliance Unable | Protocol Compliance Unwilling | Mental Disorders, Severe | Living place Remote | Time commitment
Item
inability or unwillingness to provide informed consent or abide by study requirements eg severe psychiatric illness, lives remotely, time commitment.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C0525058 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
C4046029 (UMLS CUI [5])
C0337646 (UMLS CUI [6,1])
C0205157 (UMLS CUI [6,2])
C0040223 (UMLS CUI [7,1])
C0870312 (UMLS CUI [7,2])
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