Insulin Resistance Clinical Trial
Official title:
Phase II Study of Chronic Pancreatitis and the Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality
The purpose of this study is to determine if study drug (Pioglitazone) treatment will improve
pre-diabetes (insulin resistance) or ealy diabetes and improve clinical symptoms (pain) or
laboratory evidence of chronic pancreatitis.
The goal of the investigators is to gather information from this study to help gain
understanding of a potential therapy for chronic pancreatitis.
The pancreas is a digestive organ that secretes insulin (and other hormones) into the blood
for regulating blood sugar (glucose) and digestive enzymes into the intestine for digesting
and absorbing nutrients consumed in meals. Chronic pancreatitis is a progressive clinical
disease of the pancreas, associated with swelling (inflammation), scarring (fibrosis) and
loss of normal functioning tissue. Patients develop diabetes mellitus (elevated blood sugar),
malabsorption of nutrients, weight loss and pain. Presently chronic pancreatitis is
considered an irreversible condition because the mechanisms responsible for chronic
pancreatitis are poorly understood and no therapy is proven. However, recent studies provide
important clues that oral medications (Thiazolidinediones) used to treat diabetes mellitus
might improve or reverse features of chronic pancreatitis, including elevated sugar or
diabetes, reduced secretion of digestive enzymes, and pancreatic swelling and scarring.
Note: Takeda Pharmaceuticals North America (TPNA) provided pioglitazone and placebo pills
with identically appearance until June 28, 2010, approximately the middle of the study.
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