Phase 3 Completed N=71 Randomized Quadruple-blind Prevention

Salsalate Therapy to Reduce Insulin Resistance and Cardiovascular Risk

Atherosclerosis · Cardiovascular Disease · Inflammation · Insulin Resistance

Source: ClinicalTrials.gov NCT00330733 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2014

Primary outcomePrimary: Change in Systemic Glucose Disposal- Glucose Infusion Rates — 1; 6 percent change from baseline — p=<0.05

Summary

The hypothesis is that salsalate therapy may be an effective and safe method to modulate inflammation in metabolically-critical tissues and thus reduce insulin resistance and its related complications. The objectives of the study are to (1) determine whether salsalate therapy improves insulin resistance in subjects with IGT and changes in glucose area under the curve following a standard oral glucose tolerance test (OGTT); (2) determine whether salsalate therapy reduces a) plasma levels of a variety of well established inflammatory proteins and b) mononuclear cell inflammatory activity to provide evidence of reduced systemic and tissue inflammation, respectively; and (3)also determine whether salsalate therapy improves parameters of cardiovascular disease risk, including features of metabolic syndrome (fasting glucose, triglycerides, HDL, and blood pressure) as well as endothelial dysfunction.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Systemic Glucose Disposal- Glucose Infusion Rates	1; 6	<0.05 sig
SECONDARY Glucose Area Under the Curve in These Subjects	8.98; 8.74	—
SECONDARY Plasma CRP	0; -0.8; -0.1; -.3	—
SECONDARY Endothelial Function	1.8; 1.9; 1.7; 1.7	—
SECONDARY Plasma Interleukin 6	0.1; 0; 0.2; 0	—
SECONDARY Plasma sVCAM	-12; -5; 9; 171	—
SECONDARY Plasma Adiponectin	-0.5; 1.3; -0.1; 1.2	—

Eligibility Criteria

Inclusion Criteria

Male and female veterans between the age of 21-75 who have IFG (impaired fasting glucose) and/or IGT

Exclusion Criteria

any diabetes therapy in the prior 12-months period
any acute illness
Ongoing high dose aspirin or Salsalate Therapy
history of GI bleeding
hearing problems
poor vascular access, prior pancreatitis, uncontrolled hypertension, pregnancy, renal disease or anemia

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00330733). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.