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Beneficial Effect of Salicylates: Insulin Action, Secretion or Clearance?
Not Recruiting
Trial ID: NCT02007577
Purpose
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.
Official Title
Beneficial Effect of Salicylates: Insulin Action, Secretion or Clearance?
Eligibility
Inclusion Criteria:
- Healthy volunteers,
- BMI 25-35kg/m2,
- Without severe anemia, kidney, liver disease or any current GI ulcers or bleeding
- Or on any medication contraindicated with salsalate
Exclusion Criteria:
- Recent history of GI bleed or ulcers,
- CVD or on anticoagulants
- Severe kidney or liver disease
- Allergies to aspirin
- Taking aspirin or anti inflammatory medication on a regular basis and cannot be taken
off for the duration of the study
Intervention(s):
drug: salsalate
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305