Being obese is a common problem for people with schizophrenia. People with schizophrenia are
more likely to be overweight compared to the general population. Being overweight is a major
risk factor for developing type II diabetes. Approximately 15% of people with schizophrenia
have type II diabetes. People with type II diabetes have problems with their body's insulin.
Insulin is a hormone produced by the body to control blood sugar level. Obesity and type II
diabetes are strong risk factors for heart disease. In type II diabetes the body does not
respond to insulin correctly. Obesity, type II diabetes, and insulin resistance are all
common states of inflammation. Inflammation is a reaction by the body to irritation, injury,
or infection.
Salicylates are non-steroidal anti-inflammatory drugs. Aspirin is an example of a salicylate.
These drugs work by decreasing the level of inflammation in the body. Salicylates have been
shown to decrease inflammation and improve the body's response to insulin. Improving the
body's response to insulin and decreasing inflammation could possibly reduce the risk of
developing type II diabetes. Salicylates have been known for years to be effective for the
treatment of diabetes. Salicylates increase the body's response to insulin causing blood
sugar levels to decrease. Many salicylate drugs have side effects including stomach
irritation and increased risk of bleeding. The drug for this study is called salsalate and is
different from other salicylates. Salsalate has a lower bleeding risk than aspirin. Salsalate
has been used to treat arthritis and has been shown to be safe.
There have been no studies using salsalate in people with schizophrenia. The purpose of this
study is to gain experience in the use of salsalate in people with schizophrenia. The study
would be a pilot study to obtain preliminary data. The study would be a 6-week study where
everyone in the study would receive the drug salsalate. The participants in the study will
have tests of baseline symptoms of schizophrenia, a physical exam, EKG (to check heart
function), and a side effect checklist for possible side effects from salsalate. The study
will also have some blood drawn to measure blood sugar levels, insulin levels, and
inflammatory markers.
Phase:
N/A
Details
Lead Sponsor:
University of Maryland University of Maryland, Baltimore
Collaborators:
US Department of Veterans Affairs VA Office of Research and Development