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

Pre Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007577
• Other study ID #: 19254
• Status: Completed
• Phase: N/A
• First received: March 5, 2013
• Last updated: December 9, 2013
• Start date: July 2010
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 60 Years

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Insulin Resistant
• Pre Diabetes

Intervention

Drug:
• salsalate

• Placebo

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare changes in insulin action between individuals on salsalate to placebo.		after treatment for one month	No
Secondary	compare changes in insulin secretion between those treated with salsalate to placebo.		one month on treatment	No