ID

32674

Description

Comparison of Enteral Products for Tube Fed Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00544206

Link

https://clinicaltrials.gov/show/NCT00544206

Keywords

Versions (1)
  1. 11/12/18 11/12/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 12, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00544206

English

Eligibility Type 2 Diabetes Mellitus NCT00544206

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed and dated informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
diagnosis of type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
hba1c between 7.0 and 9.0%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
18 - 75 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
currently receiving a standard enteral product
Description

Standard Product Enteral

Data type

boolean

Alias
UMLS CUI [1,1]
C1442989
UMLS CUI [1,2]
C1514468
UMLS CUI [1,3]
C1304890
anticipated duration on tube feeding at least one month
Description

Tube feeding Duration Anticipated

Data type

boolean

Alias
UMLS CUI [1,1]
C0041281
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C3840775
100% of patient's nutrient and energy needs are anticipated to be met by enteral nutrition support
Description

Enteral Nutrition Support

Data type

boolean

Alias
UMLS CUI [1,1]
C0014327
UMLS CUI [1,2]
C1521721
anticipated life expectancy is more than or equal to 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
free of infections
Description

Communicable Diseases Free of

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332296
no change in medications within 2 weeks prior to screening that could profoundly affect blood glucose
Description

Absence Change of medication Affecting Blood Glucose

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0580105
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0005802
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
composition of either product is inappropriate for the patient due to allergies or intolerance to any ingredient found in the study products
Description

Composition Investigational New Drugs Inappropriate | Hypersensitivity Investigational New Drugs Ingredient | Intolerance to Investigational New Drugs Ingredient

Data type

boolean

Alias
UMLS CUI [1,1]
C0486616
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1550600
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0013230
UMLS CUI [3,3]
C1550600
composition of either product is inappropriate for the patient due to protein, fluid or electrolyte restrictions for concomitant conditions
Description

Composition Investigational New Drugs Inappropriate | Protein Restrictions Due to Medical condition | Fluid restriction Due to Medical condition | Electrolyte Restrictions Due to Medical condition

Data type

boolean

Alias
UMLS CUI [1,1]
C0486616
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0033684
UMLS CUI [2,2]
C0443288
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C3843040
UMLS CUI [3,1]
C0204700
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C3843040
UMLS CUI [4,1]
C0013832
UMLS CUI [4,2]
C0443288
UMLS CUI [4,3]
C0678226
UMLS CUI [4,4]
C3843040
significant cardiovascular event less than or equal to 2 weeks prior to study entry
Description

Cardiovascular event

Data type

boolean

Alias
UMLS CUI [1]
C1320716
major surgery less than or equal to 2 weeks prior to study entry
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
pre-planned surgery during the study period
Description

Operative Surgical Procedures Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
active malignancy, including melanoma and excluding cutaneous malignancies
Description

Malignant Neoplasms | Melanoma | Skin Neoplasms Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0025202
UMLS CUI [3,1]
C0037286
UMLS CUI [3,2]
C0332196
severe dementia
Description

Severe dementia

Data type

boolean

Alias
UMLS CUI [1]
C3494652
known allergies to medical grade adhesives and/or skin disinfectants
Description

Allergy to adhesive | Hypersensitivity Skin Disinfectants

Data type

boolean

Alias
UMLS CUI [1]
C1635164
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1123023
UMLS CUI [2,3]
C0012682
taking octreotide
Description

Octreotide

Data type

boolean

Alias
UMLS CUI [1]
C0028833
chronic, contagious, infectious disease, such as active tuberculosis, hepatitis b or c, or hiv
Description

Chronic infectious disease | Tuberculosis | Hepatitis B | Hepatitis C | HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2]
C0041296
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
UMLS CUI [5]
C0019693
participation in a concomitant trial
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00544206

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed and dated informed consent
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosis of type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c between 7.0 and 9.0%
boolean
C0474680 (UMLS CUI [1])
Age
Item
18 - 75 years of age
boolean
C0001779 (UMLS CUI [1])
Standard Product Enteral
Item
currently receiving a standard enteral product
boolean
C1442989 (UMLS CUI [1,1])
C1514468 (UMLS CUI [1,2])
C1304890 (UMLS CUI [1,3])
Tube feeding Duration Anticipated
Item
anticipated duration on tube feeding at least one month
boolean
C0041281 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C3840775 (UMLS CUI [1,3])
Enteral Nutrition Support
Item
100% of patient's nutrient and energy needs are anticipated to be met by enteral nutrition support
boolean
C0014327 (UMLS CUI [1,1])
C1521721 (UMLS CUI [1,2])
Life Expectancy
Item
anticipated life expectancy is more than or equal to 6 months
boolean
C0023671 (UMLS CUI [1])
Communicable Diseases Free of
Item
free of infections
boolean
C0009450 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
Absence Change of medication Affecting Blood Glucose
Item
no change in medications within 2 weeks prior to screening that could profoundly affect blood glucose
boolean
C0332197 (UMLS CUI [1,1])
C0580105 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0005802 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Composition Investigational New Drugs Inappropriate | Hypersensitivity Investigational New Drugs Ingredient | Intolerance to Investigational New Drugs Ingredient
Item
composition of either product is inappropriate for the patient due to allergies or intolerance to any ingredient found in the study products
boolean
C0486616 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
C1744706 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C1550600 (UMLS CUI [3,3])
Composition Investigational New Drugs Inappropriate | Protein Restrictions Due to Medical condition | Fluid restriction Due to Medical condition | Electrolyte Restrictions Due to Medical condition
Item
composition of either product is inappropriate for the patient due to protein, fluid or electrolyte restrictions for concomitant conditions
boolean
C0486616 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0033684 (UMLS CUI [2,1])
C0443288 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C3843040 (UMLS CUI [2,4])
C0204700 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C3843040 (UMLS CUI [3,3])
C0013832 (UMLS CUI [4,1])
C0443288 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C3843040 (UMLS CUI [4,4])
Cardiovascular event
Item
significant cardiovascular event less than or equal to 2 weeks prior to study entry
boolean
C1320716 (UMLS CUI [1])
Major surgery
Item
major surgery less than or equal to 2 weeks prior to study entry
boolean
C0679637 (UMLS CUI [1])
Operative Surgical Procedures Planned
Item
pre-planned surgery during the study period
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Malignant Neoplasms | Melanoma | Skin Neoplasms Excluded
Item
active malignancy, including melanoma and excluding cutaneous malignancies
boolean
C0006826 (UMLS CUI [1])
C0025202 (UMLS CUI [2])
C0037286 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
Severe dementia
Item
severe dementia
boolean
C3494652 (UMLS CUI [1])
Allergy to adhesive | Hypersensitivity Skin Disinfectants
Item
known allergies to medical grade adhesives and/or skin disinfectants
boolean
C1635164 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1123023 (UMLS CUI [2,2])
C0012682 (UMLS CUI [2,3])
Octreotide
Item
taking octreotide
boolean
C0028833 (UMLS CUI [1])
Chronic infectious disease | Tuberculosis | Hepatitis B | Hepatitis C | HIV Infection
Item
chronic, contagious, infectious disease, such as active tuberculosis, hepatitis b or c, or hiv
boolean
C0151317 (UMLS CUI [1])
C0041296 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
C0019693 (UMLS CUI [5])
Study Subject Participation Status
Item
participation in a concomitant trial
boolean
C2348568 (UMLS CUI [1])
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