Phase 3
N=71
Salsalate Therapy to Reduce Insulin Resistance and Cardiovascular Risk
Atherosclerosis · Cardiovascular Disease · Inflammation · Insulin Resistance · Noninsulin-dependent Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00330733 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Change in Systemic Glucose Disposal- Glucose Infusion Rates — 1; 6 percent change from baseline — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Salsalate (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2010
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 | — |
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.
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
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.