ID

12040

Description

Metabolic Clock Genes During Fasting and After Food Intake in Type 2 Diabetics; ODM derived from: https://clinicaltrials.gov/show/NCT01939782 Principal Investigator: Daniela Jakubowicz, MD Diabetes Unit E. Wolfson Medical Center. Tel Aviv University

Link

https://clinicaltrials.gov/show/NCT01939782

Keywords

Versions (1)
  1. 9/2/15 9/2/15 -
Uploaded on

September 2, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT01939782

English

Eligibility Type 2 Diabetes NCT01939782

1 forms  
INCLUSION CRITERIA FOR PATIENTS WITH TYPE 2 DIABETES
Description

INCLUSION CRITERIA FOR PATIENTS WITH TYPE 2 DIABETES

Alias
UMLS CUI-1
C1512693
Type 2 diabetic patients
Description

Type 2 diabetic patients

Data type

boolean

Alias
UMLS CUI [1]
C0011860
HbA1C > 6.5%
Description

HbA1C > 6.5%

Data type

boolean

Alias
UMLS CUI [1]
C0019018
Duration of diabetes: 0.5 to 30 years
Description

Duration of diabetes: 0.5 to 30 years

Data type

boolean

Alias
UMLS CUI [1]
C0449238
Subjects ≥ 26 and ≤ 65 years of age
Description

Subjects ≥ 26 and ≤ 65 years of age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
BMI: > 26 kg/m2
Description

BMI: > 26 kg/m2

Data type

boolean

Alias
UMLS CUI [1]
C1305855
All oral antidiabetic treatments and will be allowed, not insulin treatment
Description

All oral antidiabetic treatments and will be allowed, not insulin treatment

Data type

boolean

Alias
UMLS CUI [1]
C0935929
Normal liver and kidney function
Description

Normal liver and kidney function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
Normal thyroid function
Description

Normal thyroid function

Data type

boolean

Alias
UMLS CUI [1]
C2242456
Stable physical activity pattern during the three months immediately preceding study
Description

Stable physical activity pattern during the three months immediately preceding study

Data type

boolean

Alias
UMLS CUI [1]
C0026606
No metabolic disease other than diabetes
Description

No metabolic disease other than diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0025517
Usually wakes up between 06:00 and 07:00 and goes to sleep between 22:00 and 24:00.
Description

Usually wakes up between 06:00 and 07:00 and goes to sleep between 22:00 and 24:00.

Data type

boolean

Alias
UMLS CUI [1]
C0018464
Normal TSH and FT4 levels
Description

Normal TSH and FT4 levels

Data type

boolean

Alias
UMLS CUI [1]
C0202230
No shift work within 5 years of the study
Description

No shift work within 5 years of the study

Data type

boolean

Alias
UMLS CUI [1]
C1658633
Did not cross time zones within 1 month of the study
Description

Did not cross time zones within 1 month of the study

Data type

boolean

Alias
UMLS CUI [1]
C2825194
Acceptable health beside diabetes based on interview, medical history, physical examination, and laboratory tests
Description

Acceptable health beside diabetes based on interview, medical history, physical examination, and laboratory tests

Data type

boolean

Alias
UMLS CUI [1]
C0018759
Read and understood the informed consent form and signed it voluntarily
Description

Read and understood the informed consent form and signed it voluntarily

Data type

boolean

Alias
UMLS CUI [1]
C0021430
INCLUSION CRITERIA FOR HEALTHY NON-DIABETIC PATIENTS
Description

INCLUSION CRITERIA FOR HEALTHY NON-DIABETIC PATIENTS

Alias
UMLS CUI-1
C1512693
Healthy non diabetic, and not known as diabetic
Description

Healthy non diabetic, and not known as diabetic

Data type

boolean

Alias
UMLS CUI [1]
C0424576
Fasting glucose <100 mg/dl
Description

Fasting glucose <100 mg/dl

Data type

boolean

Alias
UMLS CUI [1]
C0017725
HbA1C <5.7 %
Description

HbA1C <5.7 %

Data type

boolean

Alias
UMLS CUI [1]
C0019018
Not taking any antidiabetic drugs
Description

Not taking any antidiabetic drugs

Data type

boolean

Alias
UMLS CUI [1]
C0935929
Subjects ≥ 26 and ≤ 65 years of age
Description

Subjects ≥ 26 and ≤ 65 years of age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
BMI: <26 kg/m2
Description

BMI: <26 kg/m2

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Normal liver and kidney function
Description

Normal liver and kidney function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
Normal TSH and FT4 levels
Description

Normal TSH and FT4 levels

Data type

boolean

Alias
UMLS CUI [1]
C0202230
Usually wakes up between 06:00 and 07:00 and goes to sleep between 22:00 and 24:00.
Description

Usually wakes up between 06:00 and 07:00 and goes to sleep between 22:00 and 24:00.

Data type

boolean

Alias
UMLS CUI [1]
C0018464
No shift work within 5 years of the study
Description

No shift work within 5 years of the study

Data type

boolean

Alias
UMLS CUI [1]
C1658633
Did not cross time zones within 1 month of the study
Description

Did not cross time zones within 1 month of the study

Data type

boolean

Alias
UMLS CUI [1]
C2825194
Acceptable health based on interview, medical history, physical examination, and laboratory tests
Description

Acceptable health based on interview, medical history, physical examination, and laboratory tests

Data type

boolean

Alias
UMLS CUI [1]
C0018759
Read and understood the informed consent form and signed it voluntarily
Description

Read and understood the informed consent form and signed it voluntarily

Data type

boolean

Alias
UMLS CUI [1]
C0021430
EXCLUSION CRITERIA FOR ALL 2 GROUPS (HEALTHY AND DIABETICS)
Description

EXCLUSION CRITERIA FOR ALL 2 GROUPS (HEALTHY AND DIABETICS)

Alias
UMLS CUI-1
C0680251
Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
Description

Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease

Data type

boolean

Alias
UMLS CUI [1]
C0012634
Type 1 diabetes
Description

Type 1 diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011854
Treatment with Insulin
Description

Treatment with Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0021641
Serum creatinin level > 1.5 mg/dl
Description

Serum creatinin level > 1.5 mg/dl

Data type

boolean

Alias
UMLS CUI [1]
C0201976
Pregnancy or lactation
Description

Pregnancy or lactation

Data type

boolean

Alias
UMLS CUI [1]
C0032961
Illicit drug abuse or alcoholism
Description

Illicit drug abuse or alcoholism

Data type

boolean

Alias
UMLS CUI [1]
C0013146
Subjects on steroid treatment
Description

Subjects on steroid treatment

Data type

boolean

Alias
UMLS CUI [1]
C0149783
Subjects known by the principal investigator to be unable to cooperate for any reason.
Description

Subjects known by the principal investigator to be unable to cooperate for any reason.

Data type

boolean

Alias
UMLS CUI [1]
C0681850
Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
Description

Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)

Data type

boolean

Alias
UMLS CUI [1]
C0232741
Night or rotating shift work
Description

Night or rotating shift work

Data type

boolean

Alias
UMLS CUI [1]
C1658633
Jet lag during the 2 week period immediately prior to study onset
Description

Jet lag during the 2 week period immediately prior to study onset

Data type

boolean

Alias
UMLS CUI [1]
C0231311
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Similar models

Eligibility Type 2 Diabetes NCT01939782

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
INCLUSION CRITERIA FOR PATIENTS WITH TYPE 2 DIABETES
C1512693 (UMLS CUI-1)
type 2 diabetes
Item
Type 2 diabetic patients
boolean
C0011860 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
HbA1C > 6.5%
boolean
C0019018 (UMLS CUI [1])
duration
Item
Duration of diabetes: 0.5 to 30 years
boolean
C0449238 (UMLS CUI [1])
age
Item
Subjects ≥ 26 and ≤ 65 years of age
boolean
C0001779 (UMLS CUI [1])
bmi
Item
BMI: > 26 kg/m2
boolean
C1305855 (UMLS CUI [1])
Antidiabetics
Item
All oral antidiabetic treatments and will be allowed, not insulin treatment
boolean
C0935929 (UMLS CUI [1])
organ function
Item
Normal liver and kidney function
boolean
C0678852 (UMLS CUI [1])
thyroid function
Item
Normal thyroid function
boolean
C2242456 (UMLS CUI [1])
physical activity
Item
Stable physical activity pattern during the three months immediately preceding study
boolean
C0026606 (UMLS CUI [1])
metabolic disease
Item
No metabolic disease other than diabetes
boolean
C0025517 (UMLS CUI [1])
Behaviorial Habits
Item
Usually wakes up between 06:00 and 07:00 and goes to sleep between 22:00 and 24:00.
boolean
C0018464 (UMLS CUI [1])
TSH
Item
Normal TSH and FT4 levels
boolean
C0202230 (UMLS CUI [1])
shift work
Item
No shift work within 5 years of the study
boolean
C1658633 (UMLS CUI [1])
time zone
Item
Did not cross time zones within 1 month of the study
boolean
C2825194 (UMLS CUI [1])
health
Item
Acceptable health beside diabetes based on interview, medical history, physical examination, and laboratory tests
boolean
C0018759 (UMLS CUI [1])
informed consent
Item
Read and understood the informed consent form and signed it voluntarily
boolean
C0021430 (UMLS CUI [1])
Item Group
INCLUSION CRITERIA FOR HEALTHY NON-DIABETIC PATIENTS
C1512693 (UMLS CUI-1)
Fit and well
Item
Healthy non diabetic, and not known as diabetic
boolean
C0424576 (UMLS CUI [1])
glucose
Item
Fasting glucose <100 mg/dl
boolean
C0017725 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
HbA1C <5.7 %
boolean
C0019018 (UMLS CUI [1])
antidiabetics
Item
Not taking any antidiabetic drugs
boolean
C0935929 (UMLS CUI [1])
age
Item
Subjects ≥ 26 and ≤ 65 years of age
boolean
C0001779 (UMLS CUI [1])
bmi
Item
BMI: <26 kg/m2
boolean
C1305855 (UMLS CUI [1])
body system or organ function
Item
Normal liver and kidney function
boolean
C0678852 (UMLS CUI [1])
tsh
Item
Normal TSH and FT4 levels
boolean
C0202230 (UMLS CUI [1])
Behaviorial Habits
Item
Usually wakes up between 06:00 and 07:00 and goes to sleep between 22:00 and 24:00.
boolean
C0018464 (UMLS CUI [1])
shift work
Item
No shift work within 5 years of the study
boolean
C1658633 (UMLS CUI [1])
time zone
Item
Did not cross time zones within 1 month of the study
boolean
C2825194 (UMLS CUI [1])
health status
Item
Acceptable health based on interview, medical history, physical examination, and laboratory tests
boolean
C0018759 (UMLS CUI [1])
informed consent
Item
Read and understood the informed consent form and signed it voluntarily
boolean
C0021430 (UMLS CUI [1])
Item Group
EXCLUSION CRITERIA FOR ALL 2 GROUPS (HEALTHY AND DIABETICS)
C0680251 (UMLS CUI-1)
disease
Item
Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
boolean
C0012634 (UMLS CUI [1])
Type 1 diabetes
Item
Type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Insulin
Item
Treatment with Insulin
boolean
C0021641 (UMLS CUI [1])
Serum creatinin
Item
Serum creatinin level > 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Pregnancy
Item
Pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
drug abuse
Item
Illicit drug abuse or alcoholism
boolean
C0013146 (UMLS CUI [1])
steroid therapy
Item
Subjects on steroid treatment
boolean
C0149783 (UMLS CUI [1])
subject
Item
Subjects known by the principal investigator to be unable to cooperate for any reason.
boolean
C0681850 (UMLS CUI [1])
liver function
Item
Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
boolean
C0232741 (UMLS CUI [1])
shift work
Item
Night or rotating shift work
boolean
C1658633 (UMLS CUI [1])
Jet lag
Item
Jet lag during the 2 week period immediately prior to study onset
boolean
C0231311 (UMLS CUI [1])
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