ID

38458

Description

Expression of Longevity Genes in Response to Extended Fasting; ODM derived from: https://clinicaltrials.gov/show/NCT01059760

Link

https://clinicaltrials.gov/show/NCT01059760

Keywords

  1. 10/19/19 10/19/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 19, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Cardiovascular Disease NCT01059760

Eligibility Cardiovascular Disease NCT01059760

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. the volunteer (male or non-pregnant female, any ethnicity) must be >18 years of age.
Description

Gender | Pregnancy Absent | Ethnicity Any | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0015031
UMLS CUI [3,2]
C1552551
UMLS CUI [4]
C0001779
2. the volunteer must either have a body mass index of 25.0-35.0 kg/m2 or the combination of a body mass index of 18.5-24.9 kg/m2 and two or more previously or currently measured symptoms of the metabolic syndrome (fasting glucose≥110 mg/dl, triglycerides≥150 mg/dl, high-density lipoprotein cholesterol<40 mg/dl in males or <50 mg/dl in females, systolic blood pressure≥130 mmhg or diastolic blood pressure≥85 mmhg, or waist circumference≥40 inches in males or ≥36 inches in females [glucose and cholesterol levels may be self-reported]).
Description

Body mass index | Symptoms Quantity Metabolic Syndrome | Glucose measurement, fasting | Triglycerides measurement | Serum HDL cholesterol measurement | Gender | Systolic Pressure | Diastolic blood pressure | Waist Circumference

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0524620
UMLS CUI [3]
C0202045
UMLS CUI [4]
C0202236
UMLS CUI [5]
C0428472
UMLS CUI [6]
C0079399
UMLS CUI [7]
C0871470
UMLS CUI [8]
C0428883
UMLS CUI [9]
C0455829
3. the volunteer has not routinely participated in caloric restriction (deliberate limitation of caloric intake of <80% than the fda-recommended daily caloric intake) within the last 2 years, has not participated in extended fasting (>12 hours at a time) for at least a year, and does not deliberately skip meals as a routine dietary practice.
Description

Participation Absent Caloric Restriction | Absence Fasting Extended | Absence Skipping Meals

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1135809
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0015663
UMLS CUI [2,3]
C0439792
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0560435
UMLS CUI [3,3]
C1998602
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. body mass index <18.5 or >35 kg/m2.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
2. current active cancer treatment, treatment with immunosuppressive medications, or solid organ transplantation within 1 year.
Description

Cancer treatment | Immunosuppressive Agents | Solid organ transplant

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0021081
UMLS CUI [3]
C0730400
3. presence of immunosuppressive disease, myocardial infarction, peripheral vascular disease, or stroke within the past year.
Description

Immunosuppression | Myocardial Infarction | Peripheral Vascular Disease | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0085096
UMLS CUI [4]
C0038454
4. use of insulin.
Description

Insulin use

Data type

boolean

Alias
UMLS CUI [1]
C0240016
5. although it is unlikely fasting will harm the pregnant or lactating woman, the dietary restrictions placed on the participant for the duration of the study may conflict with dietary recommendations for pregnant or lactating women. women of child bearing potential, therefore, will meet an exclusion if they become pregnant.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961

Similar models

Eligibility Cardiovascular Disease NCT01059760

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Pregnancy Absent | Ethnicity Any | Age
Item
1. the volunteer (male or non-pregnant female, any ethnicity) must be >18 years of age.
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0015031 (UMLS CUI [3,1])
C1552551 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
Body mass index | Symptoms Quantity Metabolic Syndrome | Glucose measurement, fasting | Triglycerides measurement | Serum HDL cholesterol measurement | Gender | Systolic Pressure | Diastolic blood pressure | Waist Circumference
Item
2. the volunteer must either have a body mass index of 25.0-35.0 kg/m2 or the combination of a body mass index of 18.5-24.9 kg/m2 and two or more previously or currently measured symptoms of the metabolic syndrome (fasting glucose≥110 mg/dl, triglycerides≥150 mg/dl, high-density lipoprotein cholesterol<40 mg/dl in males or <50 mg/dl in females, systolic blood pressure≥130 mmhg or diastolic blood pressure≥85 mmhg, or waist circumference≥40 inches in males or ≥36 inches in females [glucose and cholesterol levels may be self-reported]).
boolean
C1305855 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0524620 (UMLS CUI [2,3])
C0202045 (UMLS CUI [3])
C0202236 (UMLS CUI [4])
C0428472 (UMLS CUI [5])
C0079399 (UMLS CUI [6])
C0871470 (UMLS CUI [7])
C0428883 (UMLS CUI [8])
C0455829 (UMLS CUI [9])
Participation Absent Caloric Restriction | Absence Fasting Extended | Absence Skipping Meals
Item
3. the volunteer has not routinely participated in caloric restriction (deliberate limitation of caloric intake of <80% than the fda-recommended daily caloric intake) within the last 2 years, has not participated in extended fasting (>12 hours at a time) for at least a year, and does not deliberately skip meals as a routine dietary practice.
boolean
C0679823 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1135809 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0015663 (UMLS CUI [2,2])
C0439792 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0560435 (UMLS CUI [3,2])
C1998602 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Body mass index
Item
1. body mass index <18.5 or >35 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Cancer treatment | Immunosuppressive Agents | Solid organ transplant
Item
2. current active cancer treatment, treatment with immunosuppressive medications, or solid organ transplantation within 1 year.
boolean
C0920425 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C0730400 (UMLS CUI [3])
Immunosuppression | Myocardial Infarction | Peripheral Vascular Disease | Cerebrovascular accident
Item
3. presence of immunosuppressive disease, myocardial infarction, peripheral vascular disease, or stroke within the past year.
boolean
C4048329 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0085096 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
Insulin use
Item
4. use of insulin.
boolean
C0240016 (UMLS CUI [1])
Pregnancy
Item
5. although it is unlikely fasting will harm the pregnant or lactating woman, the dietary restrictions placed on the participant for the duration of the study may conflict with dietary recommendations for pregnant or lactating women. women of child bearing potential, therefore, will meet an exclusion if they become pregnant.
boolean
C0032961 (UMLS CUI [1])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial