ID

16835

Description

Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diets to American Diet - a Pilot Study; ODM derived from: https://clinicaltrials.gov/show/NCT00379548

Link

https://clinicaltrials.gov/show/NCT00379548

Keywords

Versions (1)
  1. 8/9/16 8/9/16 -
Uploaded on

August 9, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT00379548

English

Eligibility Diabetes NCT00379548

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00379548
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. caucasian or far-east asian decent
Description

Racial group

Data type

boolean

Alias
UMLS CUI [1]
C0034510
2. ages between 25 - 55 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. has family history of diabetes defined as having a first degree relative diagnosed with diabetes mellitus, and/or medical history of gestational diabetes (gdm), impaired fasting glucose(ifg) and impaired glucose tolerance (igt)
Description

Family history of diabetes

Data type

boolean

Alias
UMLS CUI [1,1]
C1517194
UMLS CUI [1,2]
C0011849
UMLS CUI [2,1]
C1517194
UMLS CUI [2,2]
C0085207
UMLS CUI [3,1]
C1517194
UMLS CUI [3,2]
C1272092
UMLS CUI [4,1]
C1517194
UMLS CUI [4,2]
C0271650
4. bmi of 18.5 - 25.0 kg/m2
Description

BMI

Data type

boolean

Alias
UMLS CUI [1]
C1305855
5. agree to maintain constant physical activity levels for the duration of the study
Description

agree to maintain constant physical activity levels

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0026606
6. agree to utilize contraception for the duration of the study (for female subjects)
Description

agree to utilize contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
7. have a minimum of 12 natural teeth
Description

Teeth

Data type

boolean

Alias
UMLS CUI [1,1]
C0040426
UMLS CUI [1,2]
C0750480
8. scoring of 2 or more on dental screening questionnaire (see appendix)
Description

Scoring of 2 or more on dental screening questionnaire

Data type

boolean

Alias
UMLS CUI [1,1]
C1710477
UMLS CUI [1,2]
C0226984
9. ability to communicate in english
Description

language

Data type

boolean

Alias
UMLS CUI [1]
C1145677
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. acute weight loss/weight gain over the past 6 months (defined as +4 lbs or more/month)
Description

Body weight changes

Data type

boolean

Alias
UMLS CUI [1]
C0005911
2. history of diabetes
Description

History of diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011849
3. current smokers (including those who quit < 1 year)
Description

Smokers

Data type

boolean

Alias
UMLS CUI [1]
C0543414
4. heavy alcohol drinkers, defined as drinking more than 7 drinks/week. those who drink alcohol will need to be reported and documented. they will be asked to maintain the levels of alcohol consumption throughout the study.
Description

Heavy alcohol drinkers

Data type

boolean

Alias
UMLS CUI [1]
C0038586
5. medical history of vascular diseases (cad, mi, stroke, cabg, angioplasty), diabetes, liver disease, kidney disease, cancer, aids, bleeding disorders
Description

vascular diseases (cad, mi, stroke, cabg, angioplasty), diabetes, liver disease, kidney disease, cancer, aids, bleeding disorders

Data type

boolean

Alias
UMLS CUI [1]
C0042373
UMLS CUI [2]
C0010068
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0162577
UMLS CUI [6]
C0010055
UMLS CUI [7]
C0011849
UMLS CUI [8]
C0232741
UMLS CUI [9]
C0232804
UMLS CUI [10]
C0006826
UMLS CUI [11]
C0001175
UMLS CUI [12]
C0005779
6. history of food allergies or to any food products in the diet menu.
Description

food allergies

Data type

boolean

Alias
UMLS CUI [1]
C0016470
7. enrolled in another investigational study within 1 month prior to screening for this study
Description

enrolled in another investigational study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
8. vegetarian, those with significant food aversions, and anyone who cannot comply with the diet
Description

Anyone who cannot comply with the diet

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0012155
9. pregnancy or breasting feeding
Description

pregnancy or breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
10. other autoimmune or inflammatory conditions or diseases that may compromise the patient's safety or compliance during the study on an individual basis
Description

Other autoimmune or inflammatory conditions or diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0004364
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C1290884
11. chronic use of antibiotics or anti-inflammatory medications (>1 month) within the past year
Description

Use of antibiotics or anti-inflammatory medications

Data type

boolean

Alias
UMLS CUI [1]
C0003232
UMLS CUI [2]
C0003209
12. on medications such as statins, angiotensin converting enzyme inhibitor, warfarin, aspirin or other anti-inflammatory medications. daily multivitamins are permitted, excluding pharmacological doses of anti- oxidants will not be allowed.
Description

medications such as statins, angiotensin converting enzyme inhibitor, warfarin, aspirin or other anti-inflammatory medications, pharmacological doses of anti-oxidants

Data type

boolean

Alias
UMLS CUI [1]
C0360714
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0043031
UMLS CUI [4]
C0004057
UMLS CUI [5]
C0003209
UMLS CUI [6]
C0003402
13. individuals with dental needs requiring extensive dental restorations such as cavities, root canals, crowns, etc.
Description

individuals with dental needs requiring extensive dental restorations

Data type

boolean

Alias
UMLS CUI [1,1]
C0399059
UMLS CUI [1,2]
C0686904
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Similar models

Eligibility Diabetes NCT00379548

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00379548
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Racial group
Item
1. caucasian or far-east asian decent
boolean
C0034510 (UMLS CUI [1])
Age
Item
2. ages between 25 - 55 years old
boolean
C0001779 (UMLS CUI [1])
Family history of diabetes
Item
3. has family history of diabetes defined as having a first degree relative diagnosed with diabetes mellitus, and/or medical history of gestational diabetes (gdm), impaired fasting glucose(ifg) and impaired glucose tolerance (igt)
boolean
C1517194 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C1517194 (UMLS CUI [2,1])
C0085207 (UMLS CUI [2,2])
C1517194 (UMLS CUI [3,1])
C1272092 (UMLS CUI [3,2])
C1517194 (UMLS CUI [4,1])
C0271650 (UMLS CUI [4,2])
BMI
Item
4. bmi of 18.5 - 25.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
agree to maintain constant physical activity levels
Item
5. agree to maintain constant physical activity levels for the duration of the study
boolean
C1321605 (UMLS CUI [1,1])
C0026606 (UMLS CUI [1,2])
agree to utilize contraception
Item
6. agree to utilize contraception for the duration of the study (for female subjects)
boolean
C0700589 (UMLS CUI [1])
Teeth
Item
7. have a minimum of 12 natural teeth
boolean
C0040426 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Scoring of 2 or more on dental screening questionnaire
Item
8. scoring of 2 or more on dental screening questionnaire (see appendix)
boolean
C1710477 (UMLS CUI [1,1])
C0226984 (UMLS CUI [1,2])
language
Item
9. ability to communicate in english
boolean
C1145677 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Body weight changes
Item
1. acute weight loss/weight gain over the past 6 months (defined as +4 lbs or more/month)
boolean
C0005911 (UMLS CUI [1])
History of diabetes
Item
2. history of diabetes
boolean
C0011849 (UMLS CUI [1])
Smokers
Item
3. current smokers (including those who quit < 1 year)
boolean
C0543414 (UMLS CUI [1])
Heavy alcohol drinkers
Item
4. heavy alcohol drinkers, defined as drinking more than 7 drinks/week. those who drink alcohol will need to be reported and documented. they will be asked to maintain the levels of alcohol consumption throughout the study.
boolean
C0038586 (UMLS CUI [1])
vascular diseases (cad, mi, stroke, cabg, angioplasty), diabetes, liver disease, kidney disease, cancer, aids, bleeding disorders
Item
5. medical history of vascular diseases (cad, mi, stroke, cabg, angioplasty), diabetes, liver disease, kidney disease, cancer, aids, bleeding disorders
boolean
C0042373 (UMLS CUI [1])
C0010068 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0162577 (UMLS CUI [5])
C0010055 (UMLS CUI [6])
C0011849 (UMLS CUI [7])
C0232741 (UMLS CUI [8])
C0232804 (UMLS CUI [9])
C0006826 (UMLS CUI [10])
C0001175 (UMLS CUI [11])
C0005779 (UMLS CUI [12])
food allergies
Item
6. history of food allergies or to any food products in the diet menu.
boolean
C0016470 (UMLS CUI [1])
enrolled in another investigational study
Item
7. enrolled in another investigational study within 1 month prior to screening for this study
boolean
C2348568 (UMLS CUI [1])
Anyone who cannot comply with the diet
Item
8. vegetarian, those with significant food aversions, and anyone who cannot comply with the diet
boolean
C1321605 (UMLS CUI [1,1])
C0012155 (UMLS CUI [1,2])
pregnancy or breast feeding
Item
9. pregnancy or breasting feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Other autoimmune or inflammatory conditions or diseases
Item
10. other autoimmune or inflammatory conditions or diseases that may compromise the patient's safety or compliance during the study on an individual basis
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0004364 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C1290884 (UMLS CUI [2,3])
Use of antibiotics or anti-inflammatory medications
Item
11. chronic use of antibiotics or anti-inflammatory medications (>1 month) within the past year
boolean
C0003232 (UMLS CUI [1])
C0003209 (UMLS CUI [2])
medications such as statins, angiotensin converting enzyme inhibitor, warfarin, aspirin or other anti-inflammatory medications, pharmacological doses of anti-oxidants
Item
12. on medications such as statins, angiotensin converting enzyme inhibitor, warfarin, aspirin or other anti-inflammatory medications. daily multivitamins are permitted, excluding pharmacological doses of anti- oxidants will not be allowed.
boolean
C0360714 (UMLS CUI [1])
C0003015 (UMLS CUI [2])
C0043031 (UMLS CUI [3])
C0004057 (UMLS CUI [4])
C0003209 (UMLS CUI [5])
C0003402 (UMLS CUI [6])
individuals with dental needs requiring extensive dental restorations
Item
13. individuals with dental needs requiring extensive dental restorations such as cavities, root canals, crowns, etc.
boolean
C0399059 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
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