ID

37407

Description

Effect of 2-Week Nightly Moderate Hypoxia on Glucose Tolerance in Individuals With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02513641

Link

https://clinicaltrials.gov/show/NCT02513641

Keywords

Versions (1)
  1. 7/23/19 7/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT02513641

English

Eligibility Type 2 Diabetes NCT02513641

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged 20-45 yrs
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
obese category 1 and 2 (30 ≤ bmi < 45 kg/m2)
Description

Obesity Class | Body mass index

Data type

boolean

Alias
UMLS CUI [1,1]
C0028754
UMLS CUI [1,2]
C0456387
UMLS CUI [2]
C1305855
125 mg/dl < fasting blood sugar < 200 mg/dl
Description

Fasting blood glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428568
non-smokers
Description

Non-smoker

Data type

boolean

Alias
UMLS CUI [1]
C0337672
weight stable over the previous 3 months (<3 kg fluctuation)
Description

Stable body weight

Data type

boolean

Alias
UMLS CUI [1]
C0517386
has a partner/household member (≥18 y of age) that will remain within close proximity during each 7-12 h stay in the tent (in the event the alarm goes off) or willing to spend 7-12 h each night for 14 nights at the inpatient unit at pennington biomedical research center
Description

Availability of Partner Age | Availability of Household Member Age | Partner Inpatient stay Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C3887537
UMLS CUI [1,3]
C0001779
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C4330269
UMLS CUI [2,3]
C0001779
UMLS CUI [3,1]
C3887537
UMLS CUI [3,2]
C0420512
UMLS CUI [3,3]
C0600109
be willing to accept own blood being re-infused during the iv procedure associated with the oral glucose tolerance test
Description

Reinfusion Willing | Oral Glucose Tolerance Test

Data type

boolean

Alias
UMLS CUI [1,1]
C0854643
UMLS CUI [1,2]
C0600109
UMLS CUI [2]
C0029161
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosed with t2dm ≥ 10 years ago
Description

Non-Insulin-Dependent Diabetes Mellitus In the past

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C1444637
pregnant women
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
living alone and unwilling to spend 7-12 h each night at the inpatient unit at pennington biomedical research center)
Description

Living Alone | Inpatient stay Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0439044
UMLS CUI [2,1]
C0420512
UMLS CUI [2,2]
C0558080
current insulin treatment
Description

Insulin regime

Data type

boolean

Alias
UMLS CUI [1]
C0557978
treatment with sulfonylureas or glitinides
Description

Sulfonylureas | Meglitinides

Data type

boolean

Alias
UMLS CUI [1]
C0038766
UMLS CUI [2]
C1579432
chronic obstructive pulmonary disease (copd)
Description

Chronic Obstructive Airway Disease

Data type

boolean

Alias
UMLS CUI [1]
C0024117
congestive heart failure
Description

Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018802
prior severe cardiovascular events such as stroke or myocardial infarction
Description

Cardiovascular event Severe | Cerebrovascular accident | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0027051
if treated for t2dm with other oral agent, no change in the treatment for 1 month before the study and the duration of the study
Description

Oral medication unchanged Non-Insulin-Dependent Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0175795
UMLS CUI [1,2]
C0442739
UMLS CUI [1,3]
C0011860
diagnosed sleep apnea or positive screening from a night spent with watch-pat100 from itamar medical ltd.
Description

Sleep Apnea | Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C0037315
UMLS CUI [2]
C3846158
positive screening for indication of sleep apnea from a night spent with a pulse oximeter cms50f with po2 reading of 90% or less for more than 10 seconds as per romem a et al. (j clin sleep med. 2014; 10(3):285-90).
Description

Indication Sleep Apnea | Pulse oximeter | PO2, direct reading

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0037315
UMLS CUI [2]
C0182109
UMLS CUI [3]
C0546670
history of altitude sickness
Description

Altitude Sickness

Data type

boolean

Alias
UMLS CUI [1]
C0002351
does not have access to a bed or sleeping surface equivalent to or smaller than a queen size mattress.
Description

Bed Unavailable

Data type

boolean

Alias
UMLS CUI [1,1]
C0004916
UMLS CUI [1,2]
C0686905
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Similar models

Eligibility Type 2 Diabetes NCT02513641

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged 20-45 yrs
boolean
C0001779 (UMLS CUI [1])
Obesity Class | Body mass index
Item
obese category 1 and 2 (30 ≤ bmi < 45 kg/m2)
boolean
C0028754 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C1305855 (UMLS CUI [2])
Fasting blood glucose measurement
Item
125 mg/dl < fasting blood sugar < 200 mg/dl
boolean
C0428568 (UMLS CUI [1])
Non-smoker
Item
non-smokers
boolean
C0337672 (UMLS CUI [1])
Stable body weight
Item
weight stable over the previous 3 months (<3 kg fluctuation)
boolean
C0517386 (UMLS CUI [1])
Availability of Partner Age | Availability of Household Member Age | Partner Inpatient stay Willing
Item
has a partner/household member (≥18 y of age) that will remain within close proximity during each 7-12 h stay in the tent (in the event the alarm goes off) or willing to spend 7-12 h each night for 14 nights at the inpatient unit at pennington biomedical research center
boolean
C0470187 (UMLS CUI [1,1])
C3887537 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,3])
C0470187 (UMLS CUI [2,1])
C4330269 (UMLS CUI [2,2])
C0001779 (UMLS CUI [2,3])
C3887537 (UMLS CUI [3,1])
C0420512 (UMLS CUI [3,2])
C0600109 (UMLS CUI [3,3])
Reinfusion Willing | Oral Glucose Tolerance Test
Item
be willing to accept own blood being re-infused during the iv procedure associated with the oral glucose tolerance test
boolean
C0854643 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0029161 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus In the past
Item
diagnosed with t2dm ≥ 10 years ago
boolean
C0011860 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
Pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
Living Alone | Inpatient stay Unwilling
Item
living alone and unwilling to spend 7-12 h each night at the inpatient unit at pennington biomedical research center)
boolean
C0439044 (UMLS CUI [1])
C0420512 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Insulin regime
Item
current insulin treatment
boolean
C0557978 (UMLS CUI [1])
Sulfonylureas | Meglitinides
Item
treatment with sulfonylureas or glitinides
boolean
C0038766 (UMLS CUI [1])
C1579432 (UMLS CUI [2])
Chronic Obstructive Airway Disease
Item
chronic obstructive pulmonary disease (copd)
boolean
C0024117 (UMLS CUI [1])
Congestive heart failure
Item
congestive heart failure
boolean
C0018802 (UMLS CUI [1])
Cardiovascular event Severe | Cerebrovascular accident | Myocardial Infarction
Item
prior severe cardiovascular events such as stroke or myocardial infarction
boolean
C1320716 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0038454 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
Oral medication unchanged Non-Insulin-Dependent Diabetes Mellitus
Item
if treated for t2dm with other oral agent, no change in the treatment for 1 month before the study and the duration of the study
boolean
C0175795 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
C0011860 (UMLS CUI [1,3])
Sleep Apnea | Other Coding
Item
diagnosed sleep apnea or positive screening from a night spent with watch-pat100 from itamar medical ltd.
boolean
C0037315 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
Indication Sleep Apnea | Pulse oximeter | PO2, direct reading
Item
positive screening for indication of sleep apnea from a night spent with a pulse oximeter cms50f with po2 reading of 90% or less for more than 10 seconds as per romem a et al. (j clin sleep med. 2014; 10(3):285-90).
boolean
C3146298 (UMLS CUI [1,1])
C0037315 (UMLS CUI [1,2])
C0182109 (UMLS CUI [2])
C0546670 (UMLS CUI [3])
Altitude Sickness
Item
history of altitude sickness
boolean
C0002351 (UMLS CUI [1])
Bed Unavailable
Item
does not have access to a bed or sleeping surface equivalent to or smaller than a queen size mattress.
boolean
C0004916 (UMLS CUI [1,1])
C0686905 (UMLS CUI [1,2])
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