Salsalate Therapy to Reduce Insulin Resistance and Cardiovascular Risk

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborator: Joslin Diabetes Center
• Treatments: Insulin; Salicylsalicylic acid; Sodium Salicylate

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