Obesity Clinical Trial
Official title:
PET Scan Imaging of Pancreatic Beta Cell Mass With DTBZ
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.
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 cell mass and development of means to assess BCM would provide an important
endpoint. For example, high-risk individuals could be monitored prior to onset of diabetes or
patients could be monitored prospectively to determine the progression of their disease and
response to therapy.
Both Type 1 diabetes mellitus (T1DM) and Type 2 diabetes mellitus (T2DM) develop when there
is impaired insulin production. The amount of insulin that can be produced, the amount of
insulin producing beta cells in the pancreas and level of insulin and glucose in the blood
are, however, imperfectly correlated. The development of a reliable method to noninvasively
quantitate the beta cell mass (BCM) would be of great benefit by providing an important
endpoint for the development of new treatments of T1DM and T2DM. The investigators have
previously identified a specific marker on islet cells called vesicular monoamine transporter
2 (VMAT2) that they now propose to use in positron emission tomography (PET) scanning to
determine islet cell mass. This radioligand, [11C] Dihydrotetrabenazine (DTBZ), has been used
previously in human subjects in clinical trials evaluating PET scanning of the brain in
patients with bipolar illness and schizophrenia compared to healthy control subjects.
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