ID

23993

Description

Comparison of Nutritional Products for People With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00520065

Link

https://clinicaltrials.gov/show/NCT00520065

Keywords

Versions (1)
  1. 7/20/17 7/20/17 -
Uploaded on

July 20, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00520065

English

Eligibility Type 2 Diabetes Mellitus NCT00520065

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed and dated informed consent form
Description

ID.1

Data type

boolean

Alias
UMLS CUI [1]
C0021430
type 2 diabetes
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1]
C0011860
18 to 75 years of age
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1]
C0001779
male or non-pregnant, non-lactating female, at least 6 weeks postpartum
Description

ID.4

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C1180275
if female is of childbearing potential, is practicing birth control
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1]
C0700589
bmi greater than or equal to 18.5 kg/m2 and less than 40.0 kg/m2
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1]
C1305855
medications, such as antihyperglycemic or thyroid medications or hormone therapy, have been maintained at a constant dosage for at least two months prior to screening visit
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0013227
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
uses exogenous insulin for glucose control
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1]
C0557978
type 1 diabetes
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1]
C0011854
history of diabetic ketoacidosis
Description

ID.10

Data type

boolean

Alias
UMLS CUI [1]
C0011880
current infection; has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks
Description

ID.11

Data type

boolean

Alias
UMLS CUI [1,1]
C3714514
UMLS CUI [1,2]
C3540704
UMLS CUI [1,3]
C0543467
UMLS CUI [1,4]
C0149783
active malignancy
Description

ID.12

Data type

boolean

Alias
UMLS CUI [1]
C0006826
significant cardiovascular event less than 12 weeks prior to study entry
Description

ID.13

Data type

boolean

Alias
UMLS CUI [1]
C1320716
end stage organ failure or is status post organ transplant
Description

ID.14

Data type

boolean

Alias
UMLS CUI [1,1]
C0561718
UMLS CUI [1,2]
C0029216
has an active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion excluding diabetes
Description

ID.15

Data type

boolean

Alias
UMLS CUI [1,1]
C0025519
UMLS CUI [1,2]
C1961155
UMLS CUI [1,3]
C0520511
chronic, contagious, infectious disease, such as active tuberculosis, hepatitis b or c, or hiv
Description

ID.16

Data type

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0009450
taking any herbals, dietary supplements or medications, other than antihyperglycemic medications during the past four weeks that could profoundly affect blood glucose
Description

ID.17

Data type

boolean

Alias
UMLS CUI [1]
C0013227
fainted or experienced other adverse reactions in response to blood collection prior to this study
Description

ID.18

Data type

boolean

Alias
UMLS CUI [1]
C0559546
has clotting or bleeding disorders
Description

ID.19

Data type

boolean

Alias
UMLS CUI [1]
C0005779
allergic or intolerant to any ingredient found in the study products
Description

ID.20

Data type

boolean

Alias
UMLS CUI [1]
C0020517
participant in a concomitant trial that conflicts with this study
Description

ID.21

Data type

boolean

Alias
UMLS CUI [1]
C0008976
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00520065

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
signed and dated informed consent form
boolean
C0021430 (UMLS CUI [1])
ID.2
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
ID.3
Item
18 to 75 years of age
boolean
C0001779 (UMLS CUI [1])
ID.4
Item
male or non-pregnant, non-lactating female, at least 6 weeks postpartum
boolean
C0079399 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C1180275 (UMLS CUI [1,3])
ID.5
Item
if female is of childbearing potential, is practicing birth control
boolean
C0700589 (UMLS CUI [1])
ID.6
Item
bmi greater than or equal to 18.5 kg/m2 and less than 40.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
ID.7
Item
medications, such as antihyperglycemic or thyroid medications or hormone therapy, have been maintained at a constant dosage for at least two months prior to screening visit
boolean
C0205360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
ID.8
Item
uses exogenous insulin for glucose control
boolean
C0557978 (UMLS CUI [1])
ID.9
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
ID.10
Item
history of diabetic ketoacidosis
boolean
C0011880 (UMLS CUI [1])
ID.11
Item
current infection; has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks
boolean
C3714514 (UMLS CUI [1,1])
C3540704 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0149783 (UMLS CUI [1,4])
ID.12
Item
active malignancy
boolean
C0006826 (UMLS CUI [1])
ID.13
Item
significant cardiovascular event less than 12 weeks prior to study entry
boolean
C1320716 (UMLS CUI [1])
ID.14
Item
end stage organ failure or is status post organ transplant
boolean
C0561718 (UMLS CUI [1,1])
C0029216 (UMLS CUI [1,2])
ID.15
Item
has an active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion excluding diabetes
boolean
C0025519 (UMLS CUI [1,1])
C1961155 (UMLS CUI [1,2])
C0520511 (UMLS CUI [1,3])
ID.16
Item
chronic, contagious, infectious disease, such as active tuberculosis, hepatitis b or c, or hiv
boolean
C0008679 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
ID.17
Item
taking any herbals, dietary supplements or medications, other than antihyperglycemic medications during the past four weeks that could profoundly affect blood glucose
boolean
C0013227 (UMLS CUI [1])
ID.18
Item
fainted or experienced other adverse reactions in response to blood collection prior to this study
boolean
C0559546 (UMLS CUI [1])
ID.19
Item
has clotting or bleeding disorders
boolean
C0005779 (UMLS CUI [1])
ID.20
Item
allergic or intolerant to any ingredient found in the study products
boolean
C0020517 (UMLS CUI [1])
ID.21
Item
participant in a concomitant trial that conflicts with this study
boolean
C0008976 (UMLS CUI [1])
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