Clinical trial NCT02007577: Beneficial Effect of Salicylates: Insulin Action, Secretion or Clearance?
Official title: Beneficial Effect of Salicylates: Insulin Action, Secretion or Clearance?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre Diabetes
Insulin Resistant
Keywords: insulin resistant
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 41
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Quantification of Insulin Action With the Insulin Suppression Test (IST)
timeFrame: after treatment for one month
Secondary outcomes:
measure: Quantification of Insulin Clearance With the Graded Glucose Infusion Test (GGIT)
timeFrame: one month on treatment
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Gerald M Reaven, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim SH, Liu A, Ariel D, Abbasi F, Lamendola C, Grove K, Tomasso V, Ochoa H, Reaven G. Effect of salsalate on insulin action, secretion, and clearance in nondiabetic, insulin-resistant individuals: a randomized, placebo-controlled study. Diabetes Care. 2014 Jul;37(7):1944-50. doi: 10.2337/dc13-2977.