Landmark trial to evaluate cardioprotective properties ...( BUFFALO N.Y. -- The ability of insu...),Health

BUFFALO, N.Y. -- The ability of insulin to limit heart-tissue damage during a heart attack will be tested in a landmark clinical trial led by Paresh Dandona, M.D., Ph.D., University at Buffalo Distinguished Professor in the departments of Medicine and Pharmacology and Toxicology in the UB School of Medicine and Biomedical Sciences.

Approximately 600 patients at 90 centers in the U.S. and Latin America will be recruited to participate in the two-year INTENSIVE (Intensive Insulin Therapy and Size of Infarct as a Validated Endpoint by Cardiac MRI) trial. Patients in the trial, which is funded by sanofi-aventis, will be treated with two forms of insulin -- insulin glargine and insulin glulisine.

Kaleida Healths Diabetes-Endocrine Center of Western New York, which Dandona directs, will be one of the vanguard centers. The centers research facility, located in UBs New York State Center of Excellence in Bioinformatics and Life Sciences, will serve as the core laboratory.

Richard W. Nesto, M.D., associate professor at Harvard Medical School and chair of cardiovascular medicine at Lahey Clinic Medical Center in Burlington, Mass., will be co-principal investigator, directing the trials cardiovascular aspects.

The trial is based on a pilot study conducted by the diabetes center, which documented that insulin, used to treat and control type 1 and type 2 diabetes, was also cardioprotective.

This pilot study, published in the journal Circulation in 2004, was conducted in 32 patients receiving low-dose insulin. C-reactive protein (CRP) and serum amyloid A (SAA), two critical markers of inflammation, were reduced by 40 percent and 50 percent, respectively, during the 48 hours following a heart attack. Concentrations of three additional inflammatory factors also were significantly lower in those who received insulin, compared to those who did not.

The markers of myocardial damage that we measured were reduced significantly, said Dandona.
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