PET Scan Imaging of Beta Cell Mass

Completed

Conditions studied: Type 1 Diabetes, Obesity

In brief

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 weight nondiabetic people with plasma insulin levels within the normal range. Subjects with predicted reduced BCM will be recruited from among patients with T1DM who have with low or not measurable insulin levels. If results from the nondiabetic subjects and the subjects with T1DM are found to differ significantly, subjects with increased BCM will be recruited from among patients with hyperinsulinemia including those with obesity and the metabolic syndrome. PET scan measurements of the pancreas will be obtained and compared in people predicted, on the basis of biochemical testing, to have normal or reduced, or increased BCM.

Key facts

Study ID

NCT00771576

Run by

Columbia University

People needed

30

Starts

2006-09-01

Expected to finish

2012-06-13

Last updated by the study team

2017-07-18

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Naomi Berrie Diabetes Cener — New York, New York, United States
• Kreitchman PET Center Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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