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.
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 insulin levels often do not correlate well with BCM and a "gold standard
of measurement" to obtain this type of information would be of great value. The aim of the
proposed study is to evaluate an islet imaging technique using PET scanning that will be
able to be used for directly measuring BCM and thus provide valuable information for
monitoring disease progress and response to therapy in people with diabetes and in people at
high risk for diabetes. Type 1 diabetes (T1DM) occurs when the beta cells are selectively
destroyed by a T cell mediated autoimmune process. People at high risk for developing T1DM,
such as first degree relatives of patients with T1DM, can be sometimes be identified before
the disease develops by measuring autoantibodies to beta cells, however this test is neither
very sensitive or specific. In contrast, type 2 diabetes (T2DM) occurs in a setting of
insulin resistance leading to hyperinsulinemia. In people at high risk for T2DM, beta cell
mass increases to meet the demand for more insulin. The individual becomes diabetic when the
BCM and insulin production can no longer compensate for the increased need for insulin, and
blood glucose begins to rise. Loss of BCM may then occur as T2DM advances. People at high
risk for T2DM include first degree relatives of patients with T2DM and those with obesity,
insulin resistance and the metabolic syndrome. Little is known about the natural history of
BCM, turnover and cell lifetime, or the course of inflammation in diabetes. This is
principally because the pancreas is a highly heterogeneous organ that is difficult to biopsy
without significant complications, and BCM is only 1-2% of the organ. Accurate assessment of
BCM in human diabetes is limited to autopsy studies, which usually suffer from inadequate
clinical informationÍž thus, the development of noninvasive means of BCM measurement could be
important, not only in intervention therapy of T1DM and T2DM, islet regeneration/stem cell
therapy and islet transplantation.
Until recently, islet cell mass visualization has not been clinically feasible. We have
previously identified a specific marker on pancreatic beta cells called vesicular monoamine
transporter type 2 (VMAT2). In preclinical studies, we have shown that imaging beta cell
mass with PET scanning using this radioligand is feasible in rats and in dosimetry studies
conducted in baboons. This radioligand, [11C]DTBZ, has been used previously in human
subjects in clinical trials evaluating P.E.T scanning of the brain in patients with bipolar
illness and schizophrenia compared to healthy control subjects. In the current protocol, we
propose to use a radioligand, [11C]DTBZ, that binds to VMAT2 in positron emission tomography
(PET) scanning to assess whether PET can measure beta cell mass in human subjects.
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Observational Model: Case Control, Time Perspective: Cross-Sectional
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