Status:
COMPLETED
Assessment of Beta Cell Mass in Type 1 Diabetes With 11C-Dihydrotetrabenazine and PET Scan
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type I Diabetes
Eligibility:
All Genders
18+ years
Brief Summary
This study will test dihydrotetrabenazine, or 11C-DTBZ, a radioactive tracer, as an imaging agent in positron emission tomography (PET). That tracer may have the ability to noninvasively measure beta ...
Detailed Description
Diabetes is a metabolic disorder in which pancreatic insulin producing B-cells (located in cell clusters called the islets of Langerhans) no longer produce sufficient insulin to maintain an individual...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Patients with T1DM inclusion criteria:
- Age greater than 18
- History consistent with T1DM
- non-obese (BMI less than 35 kg/m(2)), and
- normal insulin sensitivity (as judged by insulin requirements less than or equal to 0.8 unit/kg/day).
- Low C-Peptide (less than or equal to 0.6 ng/ml)
- Pancreas Transplant Patient inclusion criteria:
- Age greater than 18
- History consistent with T1DM (as above) PRIOR to pancreas transplant.
- Normal pancreas allograft function for at least the preceding 1 year.
- No acute rejection episodes within the past year.
- Control Patient inclusion criteria:
- Age greater than 18
- No history of diabetes.
- Fasting blood glucose less than 100 mg/dl.
- Normal oral glucose tolerance.
- BMI less than 35 kg/m(2)
- Exclusion criteria for all:
- Liver dysfunction as determined by history, physical examination, and standard liver function testing (abnormal values for AST, ALT, Total/Direct Bilirubin, Alkaline Phosphatase)
- Coagulopathy
- Pregnancy
- Current breast feeding
- Use of MAO inhibitors or Levodopa
- Patients with a contraindication to MRI scanning.
Exclusion
Key Trial Info
Start Date :
July 9 2006
Trial Type :
OBSERVATIONAL
End Date :
February 6 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00351650
Start Date
July 9 2006
End Date
February 6 2008
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892