ID

32745

Description

Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00668954

Link

https://clinicaltrials.gov/show/NCT00668954

Keywords

Versions (1)
  1. 11/14/18 11/14/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 14, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00668954

English

Eligibility Type 2 Diabetes Mellitus NCT00668954

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
able to speak and read english
Description

Able to speak English Language | Able to read English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
have a diagnosis of type ii diabetes mellitus and currently being treated with oral medication
Description

Diabetes Mellitus, Non-Insulin-Dependent | Oral medication

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0175795
have an hba1c level ≤9.0% at screening
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
have an hscrp level ≥ 1.0 at screening
Description

hsCRP

Data type

boolean

Alias
UMLS CUI [1]
C0973334
35 - 70 years old (inclusive)
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
non-smokers
Description

Non-smoker

Data type

boolean

Alias
UMLS CUI [1]
C0337672
willing to maintain his/her normal activity and eating patterns for the duration of the study
Description

Maintenance Activity Normal | Maintenance Eating pattern Normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0024501
UMLS CUI [1,2]
C0026606
UMLS CUI [1,3]
C0205307
UMLS CUI [2,1]
C0024501
UMLS CUI [2,2]
C0392339
UMLS CUI [2,3]
C0205307
willing to maintain his/her normal diet for the duration of the study but avoid anti-oxidant rich foods and pomegranate juice (other than what is dispensed to them)
Description

Maintenance Normal diet | Avoidance Food antioxidant | Avoidance POMEGRANATE JUICE

Data type

boolean

Alias
UMLS CUI [1,1]
C0024501
UMLS CUI [1,2]
C0184625
UMLS CUI [2,1]
C0870186
UMLS CUI [2,2]
C0729311
UMLS CUI [3,1]
C0870186
UMLS CUI [3,2]
C1327962
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
allergy to pomegranates
Description

Hypersensitivity Pomegranate

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0453289
currently using insulin
Description

Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0021641
currently taking steroidal drugs
Description

Steroid drugs

Data type

boolean

Alias
UMLS CUI [1]
C0260264
hiv positive or aids
Description

HIV Seropositivity | AIDS

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0001175
chronic infectious disease
Description

Chronic infectious disease

Data type

boolean

Alias
UMLS CUI [1]
C0151317
recent (within 2 weeks of screening) cold/flu, inflammatory illness, or flare-up of gout
Description

Common Cold | Influenza | Inflammatory disorder | Flare-up Gout

Data type

boolean

Alias
UMLS CUI [1]
C0009443
UMLS CUI [2]
C0021400
UMLS CUI [3]
C1290884
UMLS CUI [4,1]
C3830105
UMLS CUI [4,2]
C0018099
cancer treated within the past two years
Description

Cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
participation in a therapeutic research study within 30 days of baseline
Description

Study Subject Participation Status | Therapies, Investigational

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
women who are pregnant, lactating, or planning to become pregnant during the study period
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00668954

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Able to speak English Language | Able to read English Language
Item
able to speak and read english
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Diabetes Mellitus, Non-Insulin-Dependent | Oral medication
Item
have a diagnosis of type ii diabetes mellitus and currently being treated with oral medication
boolean
C0011860 (UMLS CUI [1])
C0175795 (UMLS CUI [2])
Hemoglobin A1c measurement
Item
have an hba1c level ≤9.0% at screening
boolean
C0474680 (UMLS CUI [1])
hsCRP
Item
have an hscrp level ≥ 1.0 at screening
boolean
C0973334 (UMLS CUI [1])
Age
Item
35 - 70 years old (inclusive)
boolean
C0001779 (UMLS CUI [1])
Non-smoker
Item
non-smokers
boolean
C0337672 (UMLS CUI [1])
Maintenance Activity Normal | Maintenance Eating pattern Normal
Item
willing to maintain his/her normal activity and eating patterns for the duration of the study
boolean
C0024501 (UMLS CUI [1,1])
C0026606 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
C0024501 (UMLS CUI [2,1])
C0392339 (UMLS CUI [2,2])
C0205307 (UMLS CUI [2,3])
Maintenance Normal diet | Avoidance Food antioxidant | Avoidance POMEGRANATE JUICE
Item
willing to maintain his/her normal diet for the duration of the study but avoid anti-oxidant rich foods and pomegranate juice (other than what is dispensed to them)
boolean
C0024501 (UMLS CUI [1,1])
C0184625 (UMLS CUI [1,2])
C0870186 (UMLS CUI [2,1])
C0729311 (UMLS CUI [2,2])
C0870186 (UMLS CUI [3,1])
C1327962 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Pomegranate
Item
allergy to pomegranates
boolean
C0020517 (UMLS CUI [1,1])
C0453289 (UMLS CUI [1,2])
Insulin
Item
currently using insulin
boolean
C0021641 (UMLS CUI [1])
Steroid drugs
Item
currently taking steroidal drugs
boolean
C0260264 (UMLS CUI [1])
HIV Seropositivity | AIDS
Item
hiv positive or aids
boolean
C0019699 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
Chronic infectious disease
Item
chronic infectious disease
boolean
C0151317 (UMLS CUI [1])
Common Cold | Influenza | Inflammatory disorder | Flare-up Gout
Item
recent (within 2 weeks of screening) cold/flu, inflammatory illness, or flare-up of gout
boolean
C0009443 (UMLS CUI [1])
C0021400 (UMLS CUI [2])
C1290884 (UMLS CUI [3])
C3830105 (UMLS CUI [4,1])
C0018099 (UMLS CUI [4,2])
Cancer treatment
Item
cancer treated within the past two years
boolean
C0920425 (UMLS CUI [1])
Study Subject Participation Status | Therapies, Investigational
Item
participation in a therapeutic research study within 30 days of baseline
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
women who are pregnant, lactating, or planning to become pregnant during the study period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
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