Status:
COMPLETED
PET Scan Imaging of Beta Cell Mass
Lead Sponsor:
Columbia University
Conditions:
Type 1 Diabetes
Obesity
Eligibility:
All Genders
18-45 years
Brief Summary
The investigators hypothesize that PET scans will be able to differentiate between normal, reduced or increased BCM in human subjects. Subjects with normal BCM will be recruited from among normal weig...
Detailed Description
An important determinant of progression to diabetes is beta cell mass (BCM). Measurement of plasma insulin has been used as a surrogate marker but insulin levels often do not correlate well with beta ...
Eligibility Criteria
Inclusion
- Potential participants must meet all of the following inclusion criteria:
- Informed consent obtained from participants
- Age 18-45 years
- Healthy non-diabetic subjects will have normal fasting blood sugar (\<100 mg/dl), body mass index (BMI) 18.5-24.9, no history of type 2 diabetes in first degree relative
- Type 1 diabetes defined by: American Diabetes Association (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 hyper-insulinemic 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 CBC including hematocrit \>31.8% in women, \>36.7% in men, white blood cell (WBC) count \>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, 5-hydroxytryptamine (5-HT) 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
- 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 :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 13 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00771576
Start Date
September 1 2006
End Date
June 13 2012
Last Update
July 18 2017
Active Locations (2)
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1
Naomi Berrie Diabetes Cener
New York, New York, United States, 10032
2
Kreitchman PET Center Columbia University Medical Center
New York, New York, United States, 19932