Beneficial Effect of Salicylates: Insulin Action, Secretion or Clearance?

Completed · Not applicable · Has a placebo group

Conditions studied: Pre Diabetes, Insulin Resistant

In brief

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.

Key facts

Study ID

NCT02007577

Run by

Stanford University

People needed

41

Starts

2010-07-01

Expected to finish

2013-11-01

Last updated by the study team

2016-05-05

Who can join

Age: 30 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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