ID

23450

Description

Assessment of Beta Cell Mass in Type 1 Diabetes With 11C-Dihydrotetrabenazine and PET Scan; ODM derived from: https://clinicaltrials.gov/show/NCT00351650

Link

https://clinicaltrials.gov/show/NCT00351650

Keywords

Versions (1)
  1. 7/5/17 7/5/17 -
Uploaded on

July 5, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Type I Diabetes NCT00351650

English

Eligibility Type I Diabetes NCT00351650

1 forms  
Criteria
Description

Criteria

patients with t1dm inclusion criteria:
Description

Inclusion criteria Insulin-Dependent Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0011854
1. age greater than 18
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. history consistent with t1dm
Description

Medical History Consistent with Insulin-Dependent Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0011854
1. non-obese (bmi less than 35 kg/m(2)), and
Description

Obesity Absent | Body mass index

Data type

boolean

Alias
UMLS CUI [1,1]
C0028754
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C1305855
2. normal insulin sensitivity (as judged by insulin requirements less than or equal to 0.8 unit/kg/day).
Description

Insulin Sensitivity Normal | Insulin U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0920563
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0456683
3. low c-peptide (less than or equal to 0.6 ng/ml)
Description

Low C-peptide levels

Data type

boolean

Alias
UMLS CUI [1]
C4013229
pancreas transplant patient inclusion criteria:
Description

Inclusion criteria Pancreas Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0030275
1. age greater than 18
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. history consistent with t1dm (as above) prior to pancreas transplant.
Description

Medical History Consistent with Insulin-Dependent Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0011854
3. normal pancreas allograft function for at least the preceding 1 year.
Description

Allograft pancreas Function Normal

Data type

boolean

Alias
UMLS CUI [1,1]
C1720304
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0205307
4. no acute rejection episodes within the past year.
Description

Rejection episode Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0877542
UMLS CUI [1,2]
C0332197
control patient inclusion criteria:
Description

Inclusion criteria Control Group

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0009932
1. age greater than 18
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. no history of diabetes.
Description

History of diabetes mellitus Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0455488
UMLS CUI [1,2]
C0332197
3. fasting blood glucose less than 100 mg/dl.
Description

Fasting blood glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428568
4. normal oral glucose tolerance.
Description

Oral Glucose Tolerance Test Normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0029161
UMLS CUI [1,2]
C0205307
5. bmi less than 35 kg/m(2)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
exclusion criteria for all:
Description

Exclusion Criteria Patients All

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0444868
1. liver dysfunction as determined by history, physical examination, and standard liver function testing (abnormal values for ast, alt, total/direct bilirubin, alkaline phosphatase)
Description

Liver Dysfunction | Medical History | Physical Examination | Liver Function Tests Standard | AST level abnormal | ALT level abnormal | Bilirubin total abnormal | Direct bilirubin abnormal | alkaline phosphatase abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
UMLS CUI [4,1]
C0023901
UMLS CUI [4,2]
C1442989
UMLS CUI [5]
C0580475
UMLS CUI [6]
C0580469
UMLS CUI [7]
C3203647
UMLS CUI [8]
C1963962
UMLS CUI [9]
C0740888
2. coagulopathy
Description

Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0005779
3. pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
4. current breast feeding
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
5. use of mao inhibitors or levodopa
Description

Monoamine Oxidase Inhibitors | Levodopa

Data type

boolean

Alias
UMLS CUI [1]
C0026457
UMLS CUI [2]
C0023570
6. patients with a contraindication to mri scanning.
Description

Medical contraindication Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
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Similar models

Eligibility Type I Diabetes NCT00351650

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion criteria Insulin-Dependent Diabetes Mellitus
Item
patients with t1dm inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
Age
Item
1. age greater than 18
boolean
C0001779 (UMLS CUI [1])
Medical History Consistent with Insulin-Dependent Diabetes Mellitus
Item
2. history consistent with t1dm
boolean
C0262926 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0011854 (UMLS CUI [1,3])
Obesity Absent | Body mass index
Item
1. non-obese (bmi less than 35 kg/m(2)), and
boolean
C0028754 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1305855 (UMLS CUI [2])
Insulin Sensitivity Normal | Insulin U/day
Item
2. normal insulin sensitivity (as judged by insulin requirements less than or equal to 0.8 unit/kg/day).
boolean
C0920563 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Low C-peptide levels
Item
3. low c-peptide (less than or equal to 0.6 ng/ml)
boolean
C4013229 (UMLS CUI [1])
Inclusion criteria Pancreas Transplantation
Item
pancreas transplant patient inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0030275 (UMLS CUI [1,2])
Age
Item
1. age greater than 18
boolean
C0001779 (UMLS CUI [1])
Medical History Consistent with Insulin-Dependent Diabetes Mellitus
Item
2. history consistent with t1dm (as above) prior to pancreas transplant.
boolean
C0262926 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0011854 (UMLS CUI [1,3])
Allograft pancreas Function Normal
Item
3. normal pancreas allograft function for at least the preceding 1 year.
boolean
C1720304 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
Rejection episode Absent
Item
4. no acute rejection episodes within the past year.
boolean
C0877542 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Inclusion criteria Control Group
Item
control patient inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
Age
Item
1. age greater than 18
boolean
C0001779 (UMLS CUI [1])
History of diabetes mellitus Absent
Item
2. no history of diabetes.
boolean
C0455488 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Fasting blood glucose measurement
Item
3. fasting blood glucose less than 100 mg/dl.
boolean
C0428568 (UMLS CUI [1])
Oral Glucose Tolerance Test Normal
Item
4. normal oral glucose tolerance.
boolean
C0029161 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Body mass index
Item
5. bmi less than 35 kg/m(2)
boolean
C1305855 (UMLS CUI [1])
Exclusion Criteria Patients All
Item
exclusion criteria for all:
boolean
C0680251 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0444868 (UMLS CUI [1,3])
Liver Dysfunction | Medical History | Physical Examination | Liver Function Tests Standard | AST level abnormal | ALT level abnormal | Bilirubin total abnormal | Direct bilirubin abnormal | alkaline phosphatase abnormal
Item
1. liver dysfunction as determined by history, physical examination, and standard liver function testing (abnormal values for ast, alt, total/direct bilirubin, alkaline phosphatase)
boolean
C0086565 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0023901 (UMLS CUI [4,1])
C1442989 (UMLS CUI [4,2])
C0580475 (UMLS CUI [5])
C0580469 (UMLS CUI [6])
C3203647 (UMLS CUI [7])
C1963962 (UMLS CUI [8])
C0740888 (UMLS CUI [9])
Blood Coagulation Disorders
Item
2. coagulopathy
boolean
C0005779 (UMLS CUI [1])
Pregnancy
Item
3. pregnancy
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
4. current breast feeding
boolean
C0006147 (UMLS CUI [1])
Monoamine Oxidase Inhibitors | Levodopa
Item
5. use of mao inhibitors or levodopa
boolean
C0026457 (UMLS CUI [1])
C0023570 (UMLS CUI [2])
Medical contraindication Magnetic Resonance Imaging
Item
6. patients with a contraindication to mri scanning.
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
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