Salsalate Therapy to Reduce Insulin Resistance and Cardiovascular Risk

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Atherosclerosis, Cardiovascular Disease, Inflammation, Insulin Resistance, Noninsulin-dependent Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00330733

Run by

VA Office of Research and Development

People needed

71

Starts

2007-01-01

Expected to finish

2010-09-01

Last updated by the study team

2020-01-21

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Carl T. Hayden VA Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.