Diabetes Mellitus, Insulin-Dependent | Criteria Fulfill
Item
patients with type 1 diabetes may be enrolled if they meet all of the following criteria:
boolean
C0011854 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Age
Item
1. are males or females between 18 and 70 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Duration | Requirement Insulin Dose U/kg/day
Item
2. have a diagnosis of type 1 diabetes mellitus as defined by ada criteria or by diagnosed as per their endocrinologist; duration >5 years; insulin dose requirements <0.8 units/kg/day
boolean
C0011854 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1532634 (UMLS CUI [2,4])
Hemoglobin A1c measurement
Item
3. hba1c level between 5% and 8.5%
boolean
C0474680 (UMLS CUI [1])
Fasting C-peptide level
Item
4. have fasting c-peptide < 0.1 ng/ml
boolean
C2208720 (UMLS CUI [1])
Body mass index
Item
5. have a bmi between 18 and 32 kg/m2
boolean
C1305855 (UMLS CUI [1])
Ability Receive PET Imaging
Item
6. able to tolerate pet imaging
boolean
C0085732 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Ability Fasting Duration
Item
7. in the judgment of the physician, are capable of fasting 4 to 6 hours prior to screening and day 1 imaging procedures
boolean
C0085732 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Informed Consent
Item
8. give informed consent
boolean
C0021430 (UMLS CUI [1])
Healthy Volunteers | Criteria Fulfill
Item
healthy volunteers may be enrolled if they meeting all of the following criteria:
boolean
C1708335 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Age
Item
1. are males or females between 18 and 70 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus First Degree Relative Absent | Non-Insulin-Dependent Diabetes Mellitus First Degree Relative Absent
Item
2. have no history of type 1 or type 2 diabetes in a first degree relative
boolean
C0011854 (UMLS CUI [1,1])
C1517194 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0011860 (UMLS CUI [2,1])
C1517194 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Fasting blood glucose measurement
Item
3. fasting blood glucose less than 100 mg/dl
boolean
C0428568 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
4. hba1c level less than 6%
boolean
C0474680 (UMLS CUI [1])
Meal Mixed Tolerance test Normal
Item
5. normal mixed meal tolerance test at screening visit
boolean
C1998602 (UMLS CUI [1,1])
C0205430 (UMLS CUI [1,2])
C0201777 (UMLS CUI [1,3])
C0205307 (UMLS CUI [1,4])
Body mass index
Item
6. bmi between 18 and 32 kg/m2
boolean
C1305855 (UMLS CUI [1])
Ability Receive PET Imaging
Item
7. able to tolerate pet imaging
boolean
C0085732 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Ability Fasting Duration
Item
8. in the judgment of the physician, are capable of fasting 4 to 6 hours prior to screening and day 1 imaging procedures, and
boolean
C0085732 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Informed Consent
Item
9. give informed consent
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria Any
Item
potential participants must not have any of the following exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Renal dysfunction
Item
1. clinically significant renal dysfunction
boolean
C3279454 (UMLS CUI [1])
Liver Dysfunction Medical History | Liver Dysfunction Physical Examination | Liver Function Tests | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Bilirubin, direct measurement | Alkaline phosphatase measurement
Item
2. clinically significant liver dysfunction as determined by history, physical examination, and standard liver function testing at screening (ast, alt, total/direct bilirubin, alkaline phosphatase)
boolean
C0086565 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C0023901 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C0201916 (UMLS CUI [7])
C0201850 (UMLS CUI [8])
Blood Coagulation Disorders
Item
3. coagulopathy
boolean
C0005779 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Dopamine function | Monoamine Oxidase Inhibitors | Tetrabenazine | Levodopa
Item
4. use medications known to affect dopaminergic function, including mao inhibitors, tetrabenazine, or levodopa
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0013030 (UMLS CUI [1,3])
C0031843 (UMLS CUI [1,4])
C0026457 (UMLS CUI [2])
C0039623 (UMLS CUI [3])
C0023570 (UMLS CUI [4])
Pharmaceutical Preparations Influence Beta Cell Function | Pharmaceutical Preparations Influence Insulin Sensitivity | Glucocorticoids | Reserpine | Pharmaceutical Preparations Affecting Dopamine Function | Monoamine Oxidase Inhibitors | Tetrabenazine | Levodopa
Item
5. recent (within 3 months) or current treatment with drugs influencing beta cell function or insulin sensitivity (e.g. glucocorticoids, reserpine) medications known to affect dopaminergic function, including mao inhibitors, tetrabenazine, or levodopa
boolean
C0013227 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0030281 (UMLS CUI [1,3])
C0031843 (UMLS CUI [1,4])
C0013227 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C0920563 (UMLS CUI [2,3])
C0017710 (UMLS CUI [3])
C0035179 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0013030 (UMLS CUI [5,3])
C0031843 (UMLS CUI [5,4])
C0026457 (UMLS CUI [6])
C0039623 (UMLS CUI [7])
C0023570 (UMLS CUI [8])
Polycystic Ovary Syndrome
Item
6. have polycystic ovarian syndrome
boolean
C0032460 (UMLS CUI [1])
Movement Disorders | Parkinson Disease | Huntington Disease
Item
7. history of movement disorder such as parkinson's disease, huntington's disease
boolean
C0026650 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
C0020179 (UMLS CUI [3])
Mental disorders | Depressive disorder | Bipolar Disorder | Anxiety | Schizophrenia
Item
8. clinically significant psychiatric disease or history of psychiatric illness such as depression, bipolar disease, anxiety or schizophrenia
boolean
C0004936 (UMLS CUI [1])
C0011581 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
C0003467 (UMLS CUI [4])
C0036341 (UMLS CUI [5])
Cocaine | Methamphetamine | Ecstasy
Item
9. current use (within past year) of cocaine, methamphetamine, and/or ecstasy (mdma,3,4methylenedioxymethamphetamine)
boolean
C0009170 (UMLS CUI [1])
C0025611 (UMLS CUI [2])
C0115471 (UMLS CUI [3])
Substance Use Disorders | Substance Dependence
Item
10. have a recent history of alcohol or substance abuse or dependence
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Cardiovascular Diseases | ECG abnormal | Prolonged QTc interval
Item
11. clinically significant cardiovascular disease or clinically significant abnormalities on screening ecg (including but not limited to qtc > 450 msec)
boolean
C0007222 (UMLS CUI [1])
C0522055 (UMLS CUI [2])
C1560305 (UMLS CUI [3])
Pulmonary function impairment | Renal Insufficiency | Hepatic impairment | Malignant Neoplasms
Item
12. clinically significant pulmonary, renal or hepatic impairment, or cancer
boolean
C0858943 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0948807 (UMLS CUI [3])
C0006826 (UMLS CUI [4])
Communicable Diseases | AIDS | HIV Infections | Hepatitis B test positive | Hepatitis C test positive | HIV-1 test positive | HIV-2 test positive
Item
13. have clinically significant infectious disease, including aids or hiv infection or previous positive test for hepatitis b, hepatitis c, hiv1, or hiv2
boolean
C0009450 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C1608966 (UMLS CUI [4])
C1609517 (UMLS CUI [5])
C1328593 (UMLS CUI [6])
C1168371 (UMLS CUI [7])
Childbearing Potential Sexually active | Childbearing Potential Contraceptive methods Absent
Item
14. are women of childbearing potential not refraining from sexual activity or not using adequate contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Gender | Pregnancy Absent | Serum pregnancy test (B-HCG) Negative | Breast Feeding Absent | Gender Contraceptive methods Willing
Item
women must not be pregnant (negative serum hcg at the time of screen) or breastfeeding at screening, and must agree to take appropriate steps not to become pregnant during for 30 days following the clinical trial
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0430060 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C0006147 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0600109 (UMLS CUI [5,3])
Warfarin | Study Subject Participation Status | Investigational New Drugs
Item
15. require medications with a narrow therapeutic window (e.g., warfarin), are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days
boolean
C0043031 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Body Weight Inappropriate PET/CT scan
Item
16. weigh more than the manufacturer recommended limit for the pet/ct camera being used
boolean
C0005910 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1699633 (UMLS CUI [1,3])
Study Subject Participation Status | Clinical Trials Therapeutic radiology procedure Involved | Exception Plain chest X-ray
Item
17. any prior participation in other research protocols within the past month that involved radiation, with the exception of plain radiography studies (i.e., chest x-rays); and
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0039985 (UMLS CUI [3,2])
Radiopharmaceuticals
Item
18. have received a diagnostic or therapeutic radiopharmaceutical within the past week
boolean
C0182638 (UMLS CUI [1])