Pre Diabetes Clinical Trial
Official title:
Beneficial Effect of Salicylates: Insulin Action, Secretion or Clearance?
The possibility that obesity-associated inflammatory changes may play a role in the
pathogenesis of type 2 diabetes (2DM) has led to increased interest in the possibility that
salicylates might represent a useful treatment to improve glucose tolerance. Several
studies, performed in patients with 2DM, as well as in nondiabetic, obese individuals, have
demonstrated that salicylates have beneficial effects on glucose and insulin metabolism, but
have not led to a coherent view as to the mechanism(s) involved.
In this research proposal we will use specific methods to quantify insulin mediated glucose
uptake (IMGU), glucose-stimulated insulin secretion rate (GS-ISR), and insulin clearance
(I-Cl) in overweight/obese, nondiabetic, insulin resistant individuals. We will use the
insulin suppression test (IST) to quantify IMGU in nondiabetic, overweight/obese volunteers
to identify those individuals who are sufficiently insulin resistant to be enrolled in this
study. We will then use the graded glucose infusion technique in these insulin resistant
subjects to generate specific measures of both GS-IS and I-Cl. Following these baseline
measurements, salsalate or placebo will be administered for one month to the participants,
after which time the IST and the graded glucose infusion will be repeated to quantify and
compare the changes in IMGU, GS-ISR, and I-Cl that have resulted from salsalate versus
placebo. These results will provide for the first time quantitative data of the effect of
salicylates on IMGU, GS-ISR, and I-Cl in overweight/obese, insulin resistant, nondiabetic
individuals.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
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