ID

33198

Description

PET-CT Scan Method to Monitor Pancreatic B-Cell Loss in Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00633763

Link

https://clinicaltrials.gov/show/NCT00633763

Keywords

Versions (1)
  1. 12/1/18 12/1/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 1, 2018

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.

Back to model comments
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 Type1 Diabetes Mellitus NCT00633763

English

Eligibility Type1 Diabetes Mellitus NCT00633763

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
t1dm patients that are over 18 years of age, have had t1dm for greater than 5 years and show a greater than 80% reduction in c-peptide blood levels following intravenous glucagon injection are eligible to participate in this study.
Description

Insulin-Dependent Diabetes Mellitus Disease length | Age | Glucagon Injection Intravenous | Reduced C-peptide level Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C4026725
UMLS CUI [3,2]
C1522726
UMLS CUI [4,1]
C4280764
UMLS CUI [4,2]
C0439165
healthy controls that are over 18 years of age, show normal c-peptide blood levels following intravenous glucagon injection, and are age- and sex-matched with one of the t1dm patients included in the study, are eligible to participate in this study.
Description

Healthy Control | Age | Glucagon Injection Intravenous | Blood insulin C-peptide normal | Age matched Insulin-Dependent Diabetes Mellitus Patient | Gender matched Insulin-Dependent Diabetes Mellitus Patient

Data type

boolean

Alias
UMLS CUI [1]
C2986479
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C4026725
UMLS CUI [3,2]
C1522726
UMLS CUI [4]
C0855719
UMLS CUI [5,1]
C0001779
UMLS CUI [5,2]
C0150103
UMLS CUI [5,3]
C0011854
UMLS CUI [5,4]
C0030705
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0150103
UMLS CUI [6,3]
C0011854
UMLS CUI [6,4]
C0030705
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
t1dm patients or healthy controls that are not over 18 years of age are not eligible to participate in this study.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
pregnant females are not eligible to participate in this study because there is a chance pet/ct scans might be risky for the developing baby. females physically capable of getting pregnant will be required to get a urine pregnancy test at no cost before each of the pet/ct scans. if the pregnancy test is positive, the t1dm patient or healthy control will be excluded from the study. the consent form describes the risks in detail and the need for women of childbearing age to undergo a pregnancy test.
Description

Pregnancy | Cause PET/CT scan Risk | Childbearing Potential Urine pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C1699633
UMLS CUI [2,3]
C0035647
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430056
subjects with a history of psychiatric illness, substance abuse history, clinically significant head trauma, active neurological disease, cardiovascular disease, liver disease or renal impairment, claustrophobia ((very upset and afraid of being in a small space) are not eligible for the study. dr. ping wang will use the subjects history, blood chemistry, to identify individuals with cardiovascular disease, liver disease, or renal impairment.
Description

Mental disorders | Substance Use Disorders | Craniocerebral Trauma | Nervous system disorder | Cardiovascular Disease | Liver disease | Renal Insufficiency | Claustrophobia

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0038586
UMLS CUI [3]
C0018674
UMLS CUI [4]
C0027765
UMLS CUI [5]
C0007222
UMLS CUI [6]
C0023895
UMLS CUI [7]
C1565489
UMLS CUI [8]
C0008909
t1dm patients with c-peptide levels following intravenous glucagon injection that are not reduced greater than 80% are not eligible for the study.
Description

Diabetes Mellitus, Insulin-Dependent | Glucagon Injection Intravenous | Absence Reduced C-peptide level Percentage

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C4026725
UMLS CUI [2,2]
C1522726
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C4280764
UMLS CUI [3,3]
C0439165
healthy volunteers with c-peptide levels following intravenous glucagon injection that are reduced greater than 20% compared to established control values are not eligible for the study.
Description

Healthy Volunteers | Glucagon Injection Intravenous | Reduced C-peptide level Percentage

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C4026725
UMLS CUI [2,2]
C1522726
UMLS CUI [3,1]
C4280764
UMLS CUI [3,2]
C0439165
to determine if it is safe to do the procedure, t1dm patients and healthy volunteers will be expected to tell the researchers about any radiation exposure the individual may have had (including diagnostic or treatment x-rays), and any history of head injury, kidney or bladder disease, or any other serious medical conditions.
Description

Exposure to Therapeutic radiology procedure | Exposure to X-ray diagnosis | Exposure to X-Ray Therapy | Craniocerebral Trauma | Kidney Diseases | Urinary Bladder Diseases | Other medical condition Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1522449
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0034571
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C0043308
UMLS CUI [4]
C0018674
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0005686
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C0205404
t1dm patients and healthy volunteers will be expected to tell the researchers if they have surgical clips or metallic prostheses (i.e., replacement body parts, such as a hip joint) or a pacemaker or other pieces of metal in the body (shrapnel, metal filings, etc.).
Description

Surgical Clips | Prosthesis Metallic | Replacement Body part | Hip joint replacement | Artificial cardiac pacemaker | Shrapnel | File Metallic

Data type

boolean

Alias
UMLS CUI [1]
C0038917
UMLS CUI [2,1]
C0175649
UMLS CUI [2,2]
C2986473
UMLS CUI [3,1]
C0559956
UMLS CUI [3,2]
C0229962
UMLS CUI [4]
C0850128
UMLS CUI [5]
C0030163
UMLS CUI [6]
C0522670
UMLS CUI [7,1]
C0180853
UMLS CUI [7,2]
C2986473
patients with history of alcoholism or significant alcohol consumption will be excluded from the study.
Description

Alcoholic Intoxication, Chronic | Alcohol consumption Significant

Data type

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0750502
the consent form will be english, and non-english speakers will therefore be excluded from the study.
Description

Lacking Able to speak English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
pregnant women are excluded because 18f-fallypride is a radioactive substance , which will be injected into the patient and could be hazardous to the fetus.
Description

Pregnancy | Cause 18f-fallypride Hazardous Substance

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0300404
UMLS CUI [2,3]
C0018626
Back to the top of the page

Similar models

Eligibility Type1 Diabetes Mellitus NCT00633763

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length | Age | Glucagon Injection Intravenous | Reduced C-peptide level Percentage
Item
t1dm patients that are over 18 years of age, have had t1dm for greater than 5 years and show a greater than 80% reduction in c-peptide blood levels following intravenous glucagon injection are eligible to participate in this study.
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C4026725 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C4280764 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
Healthy Control | Age | Glucagon Injection Intravenous | Blood insulin C-peptide normal | Age matched Insulin-Dependent Diabetes Mellitus Patient | Gender matched Insulin-Dependent Diabetes Mellitus Patient
Item
healthy controls that are over 18 years of age, show normal c-peptide blood levels following intravenous glucagon injection, and are age- and sex-matched with one of the t1dm patients included in the study, are eligible to participate in this study.
boolean
C2986479 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C4026725 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C0855719 (UMLS CUI [4])
C0001779 (UMLS CUI [5,1])
C0150103 (UMLS CUI [5,2])
C0011854 (UMLS CUI [5,3])
C0030705 (UMLS CUI [5,4])
C0079399 (UMLS CUI [6,1])
C0150103 (UMLS CUI [6,2])
C0011854 (UMLS CUI [6,3])
C0030705 (UMLS CUI [6,4])
Item Group
C0680251 (UMLS CUI)
Age
Item
t1dm patients or healthy controls that are not over 18 years of age are not eligible to participate in this study.
boolean
C0001779 (UMLS CUI [1])
Pregnancy | Cause PET/CT scan Risk | Childbearing Potential Urine pregnancy test
Item
pregnant females are not eligible to participate in this study because there is a chance pet/ct scans might be risky for the developing baby. females physically capable of getting pregnant will be required to get a urine pregnancy test at no cost before each of the pet/ct scans. if the pregnancy test is positive, the t1dm patient or healthy control will be excluded from the study. the consent form describes the risks in detail and the need for women of childbearing age to undergo a pregnancy test.
boolean
C0032961 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C1699633 (UMLS CUI [2,2])
C0035647 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0430056 (UMLS CUI [3,2])
Mental disorders | Substance Use Disorders | Craniocerebral Trauma | Nervous system disorder | Cardiovascular Disease | Liver disease | Renal Insufficiency | Claustrophobia
Item
subjects with a history of psychiatric illness, substance abuse history, clinically significant head trauma, active neurological disease, cardiovascular disease, liver disease or renal impairment, claustrophobia ((very upset and afraid of being in a small space) are not eligible for the study. dr. ping wang will use the subjects history, blood chemistry, to identify individuals with cardiovascular disease, liver disease, or renal impairment.
boolean
C0004936 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0018674 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C0007222 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C1565489 (UMLS CUI [7])
C0008909 (UMLS CUI [8])
Diabetes Mellitus, Insulin-Dependent | Glucagon Injection Intravenous | Absence Reduced C-peptide level Percentage
Item
t1dm patients with c-peptide levels following intravenous glucagon injection that are not reduced greater than 80% are not eligible for the study.
boolean
C0011854 (UMLS CUI [1])
C4026725 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C4280764 (UMLS CUI [3,2])
C0439165 (UMLS CUI [3,3])
Healthy Volunteers | Glucagon Injection Intravenous | Reduced C-peptide level Percentage
Item
healthy volunteers with c-peptide levels following intravenous glucagon injection that are reduced greater than 20% compared to established control values are not eligible for the study.
boolean
C1708335 (UMLS CUI [1])
C4026725 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C4280764 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
Exposure to Therapeutic radiology procedure | Exposure to X-ray diagnosis | Exposure to X-Ray Therapy | Craniocerebral Trauma | Kidney Diseases | Urinary Bladder Diseases | Other medical condition Serious
Item
to determine if it is safe to do the procedure, t1dm patients and healthy volunteers will be expected to tell the researchers about any radiation exposure the individual may have had (including diagnostic or treatment x-rays), and any history of head injury, kidney or bladder disease, or any other serious medical conditions.
boolean
C0332157 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0034571 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C0043308 (UMLS CUI [3,2])
C0018674 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0005686 (UMLS CUI [6])
C3843040 (UMLS CUI [7,1])
C0205404 (UMLS CUI [7,2])
Surgical Clips | Prosthesis Metallic | Replacement Body part | Hip joint replacement | Artificial cardiac pacemaker | Shrapnel | File Metallic
Item
t1dm patients and healthy volunteers will be expected to tell the researchers if they have surgical clips or metallic prostheses (i.e., replacement body parts, such as a hip joint) or a pacemaker or other pieces of metal in the body (shrapnel, metal filings, etc.).
boolean
C0038917 (UMLS CUI [1])
C0175649 (UMLS CUI [2,1])
C2986473 (UMLS CUI [2,2])
C0559956 (UMLS CUI [3,1])
C0229962 (UMLS CUI [3,2])
C0850128 (UMLS CUI [4])
C0030163 (UMLS CUI [5])
C0522670 (UMLS CUI [6])
C0180853 (UMLS CUI [7,1])
C2986473 (UMLS CUI [7,2])
Alcoholic Intoxication, Chronic | Alcohol consumption Significant
Item
patients with history of alcoholism or significant alcohol consumption will be excluded from the study.
boolean
C0001973 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Lacking Able to speak English Language
Item
the consent form will be english, and non-english speakers will therefore be excluded from the study.
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
Pregnancy | Cause 18f-fallypride Hazardous Substance
Item
pregnant women are excluded because 18f-fallypride is a radioactive substance , which will be injected into the patient and could be hazardous to the fetus.
boolean
C0032961 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0300404 (UMLS CUI [2,2])
C0018626 (UMLS CUI [2,3])
Back to the top of the page 

Contact

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

Fields marked with * are required.

Help

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