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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02007577
Other study ID # 19254
Secondary ID
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


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
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