ID

14103

Description

Diabetes Aerobic and Resistance Exercise (DARE) Study; ODM derived from: https://clinicaltrials.gov/show/NCT00195884

Link

https://clinicaltrials.gov/show/NCT00195884

Keywords

Versions (1)
  1. 3/29/16 3/29/16 -
Uploaded on

March 29, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00195884

English

Eligibility Diabetes Mellitus, Type 2 NCT00195884

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus as defined by the 1998 cda guidelines
Description

Type 2 diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011860
male or female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
treated with diet and/or oral agents (no insulin)
Description

Diabetic diet and/ or agents

Data type

boolean

Alias
UMLS CUI [1]
C0011878
UMLS CUI [2]
C0935929
age 40-70
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
hba1c 0.066-0.099
Description

Hba1c

Data type

boolean

Alias
UMLS CUI [1]
C0019018
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participation during the previous 6 months in a regular program of exercise or aerobic sports greater than 2 times per week for at least 20 minutes per session, or in any resistance training during the previous 6 months
Description

Exercises

Data type

boolean

Alias
UMLS CUI [1]
C0452240
insulin therapy, or uncontrolled hyperglycemia (hba1c>0.099). insulin therapy is an exclusion criterion because it would render homa insulin sensitivity calculation invalid.
Description

Insulin therapy, or uncontrolled hyperglycemia

Data type

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2]
C0019018
changes in medications for diabetes, bp or lipids in the 2 months prior to enrollment.
Description

Changes in medication

Data type

boolean

Alias
UMLS CUI [1]
C0580105
significant weight change (increase or decrease of greater than 5% of body weight during the two months before enrollment).
Description

Weight change

Data type

boolean

Alias
UMLS CUI [1]
C0005911
significant renal disease: serum creatinine greater than 200 meq/l. or proteinuria >1 g/24 hours.
Description

Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0033687
uncontrolled hypertension: bp >160 mm hg systolic or >95 mm hg diastolic bp in a sitting position.
Description

Blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
restrictions in physical activity due to disease: intermittent claudication, severe peripheral neuropathy or active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis.
Description

Restrictions in physical activity

Data type

boolean

Alias
UMLS CUI [1]
C0021775
UMLS CUI [2]
C0031117
UMLS CUI [3]
C0339467
UMLS CUI [4]
C0018799
UMLS CUI [5]
C0024115
UMLS CUI [6]
C0038454
UMLS CUI [7]
C0003864
other illness, judged by the patient or study physician to make participation in this study inadvisable.
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
significant cognitive deficit resulting in inability to understand or comply with instructions.
Description

Compliance limited by cognitive deficit

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009241
pregnancy at the start of the study, or intention to become pregnant in the next year.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
inability to communicate in english or french.
Description

Language

Data type

boolean

Alias
UMLS CUI [1]
C1145677
unwillingness to sign informed consent.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00195884

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Type 2 diabetes mellitus
Item
type 2 diabetes mellitus as defined by the 1998 cda guidelines
boolean
C0011860 (UMLS CUI [1])
Gender
Item
male or female
boolean
C0079399 (UMLS CUI [1])
Diabetic diet and/ or agents
Item
treated with diet and/or oral agents (no insulin)
boolean
C0011878 (UMLS CUI [1])
C0935929 (UMLS CUI [2])
Age
Item
age 40-70
boolean
C0001779 (UMLS CUI [1])
Hba1c
Item
hba1c 0.066-0.099
boolean
C0019018 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exercises
Item
participation during the previous 6 months in a regular program of exercise or aerobic sports greater than 2 times per week for at least 20 minutes per session, or in any resistance training during the previous 6 months
boolean
C0452240 (UMLS CUI [1])
Insulin therapy, or uncontrolled hyperglycemia
Item
insulin therapy, or uncontrolled hyperglycemia (hba1c>0.099). insulin therapy is an exclusion criterion because it would render homa insulin sensitivity calculation invalid.
boolean
C0557978 (UMLS CUI [1])
C0019018 (UMLS CUI [2])
Changes in medication
Item
changes in medications for diabetes, bp or lipids in the 2 months prior to enrollment.
boolean
C0580105 (UMLS CUI [1])
Weight change
Item
significant weight change (increase or decrease of greater than 5% of body weight during the two months before enrollment).
boolean
C0005911 (UMLS CUI [1])
Renal function
Item
significant renal disease: serum creatinine greater than 200 meq/l. or proteinuria >1 g/24 hours.
boolean
C0201976 (UMLS CUI [1])
C0033687 (UMLS CUI [2])
Blood pressure
Item
uncontrolled hypertension: bp >160 mm hg systolic or >95 mm hg diastolic bp in a sitting position.
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Restrictions in physical activity
Item
restrictions in physical activity due to disease: intermittent claudication, severe peripheral neuropathy or active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis.
boolean
C0021775 (UMLS CUI [1])
C0031117 (UMLS CUI [2])
C0339467 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
C0024115 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
C0003864 (UMLS CUI [7])
Comorbidity
Item
other illness, judged by the patient or study physician to make participation in this study inadvisable.
boolean
C0009488 (UMLS CUI [1])
Compliance limited by cognitive deficit
Item
significant cognitive deficit resulting in inability to understand or comply with instructions.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009241 (UMLS CUI [1,3])
Pregnancy
Item
pregnancy at the start of the study, or intention to become pregnant in the next year.
boolean
C0032961 (UMLS CUI [1])
Language
Item
inability to communicate in english or french.
boolean
C1145677 (UMLS CUI [1])
Informed consent
Item
unwillingness to sign informed consent.
boolean
C0021430 (UMLS CUI [1])
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