Type 1 Diabetes Clinical Trial
Official title:
Assessment of Beta Cell Mass by PET Scans With [11C] DTBZ in Longstanding Type 1 Diabetes
We hypothesize that quantitative measurements of the beta cell mass within the endocrine pancreas can be obtained by PET via targeting of vesicular monoamine type 2 transporters with the radioligand [11C]DTBZ. and that there will be significant differences in [11C]DTBZ uptake in the anatomical space of the pancreas between normal individuals and those with BCM predicted to be greater or less than normal based on the measurement of insulin secretion.
Status | Completed |
Enrollment | 18 |
Est. completion date | May 2008 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: Potential participants must meet all of the following inclusion
criteria: 1. Informed consent obtained from participants 2. Age 18 45 years 3. Healthy nondiabetic subjects will have normal fasting blood sugar (<100 mg/dl), BMI 18.5 24.9, no history of type 2 diabetes in first degree relative 4. Type 1 diabetes defined by: ADA criteria or judgment of physician; diabetes onset younger than age 18, duration >5 years, BMI 18.5 24.9. Insulin dose <0.8 units/kg/day. Fasting c-peptide < 0.1 ng/ml 5. Obese hyperinsulinemic subjects will have BMI > 30 and fasting insulin>20 and c-peptide> 4.6 ng/ml and normal fasting blood sugar <100 mg/dl. 6. Able to tolerate PET imaging: not claustrophobic, able to lie supine for 1.5 hours 7. Normal liver and renal function tests including normal spot urine microalbumin/creatinine; normal complete blood count (CBC) including hematocrit >31.8% in women, >36.7% in men, white blood cell count (WBC) >3.4 K/mm3 and platelet count >162 K/mm3 8. Adequate collateral circulation in the wrist as assessed by Allen Test. Exclusion Criteria: Potential participants must not have any of the following exclusion criteria: 1. Previous or current treatment with drugs influencing beta cell function or insulin sensitivity (e.g. oral hypoglycemic agents, glucocorticoids); or with antipsychotic, antianxiety, or antidepressant medications (eg monoamine oxidase (MAO) inhibitors, 5HT inhibitors, tricyclic antidepressants); or treatment with reserpine; or treatment with beta2receptor agonists (eg, terbutaline); or treatment with anticoagulant medication. 2. History of movement disorder such as Parkinson's Disease or Huntington's Disease 3. History of or psychiatric illness such as depression, bipolar disease, anxiety or schizophrenia. 4. If a female of childbearing age, currently pregnant, breastfeeding or not using a form of birth control 5. Previous or current use of cocaine, methamphetamine, ecstasy ( 3,4 methylenedioxymethamphetamine (MDMA)) 6. Current daily intake of caffeine >500 mg/day (>45 cups of coffee; >10 12oz cans of soda) 7. Current history of cigarette smoking 8. Consumption of more than 1 alcoholic drink per day 9. Evidence of chronic infection 10. History of malignancy 11. Any prior participation in other research protocols within the past year that involve radiation, with the exception of plain radiography studies (i.e., chest xrays). 12. Medical implant |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pancreatic tracer binding as standardized uptake value (SUV) or binding potential (BPnd) | Reflects tissue density of biomarker | measured over 60-120 minutes | No |
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