Status:
COMPLETED
Assessment of Beta Cell Mass by PET Scans With [11C] Dihydrotetrabenazine (DTBZ) in Longstanding Type 1 Diabetes.
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-45 years
Brief Summary
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 \...
Detailed Description
Diabetes results when the insulin secretory capacity of the beta cell population is lost or severely compromised. Plasma insulin levels have been used as a surrogate marker of beta cell mass (BCM) but...
Eligibility Criteria
Inclusion
- Potential participants must meet all of the following inclusion criteria:
- Informed consent obtained from participants
- Age 18 45 years
- 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
- 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
- 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.
- Able to tolerate PET imaging: not claustrophobic, able to lie supine for 1.5 hours
- 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
- Adequate collateral circulation in the wrist as assessed by Allen Test.
Exclusion
- Potential participants must not have any of the following exclusion criteria:
- 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.
- History of movement disorder such as Parkinson's Disease or Huntington's Disease
- History of or psychiatric illness such as depression, bipolar disease, anxiety or schizophrenia.
- If a female of childbearing age, currently pregnant, breastfeeding or not using a form of birth control
- Previous or current use of cocaine, methamphetamine, ecstasy ( 3,4 methylenedioxymethamphetamine (MDMA))
- Current daily intake of caffeine \>500 mg/day (\>45 cups of coffee; \>10 12oz cans of soda)
- Current history of cigarette smoking
- Consumption of more than 1 alcoholic drink per day
- Evidence of chronic infection
- History of malignancy
- 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).
- Medical implant
Key Trial Info
Start Date :
November 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00738907
Start Date
November 1 2006
End Date
May 1 2008
Last Update
September 25 2014
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