Effects of pioglitazone on endocrine function, quality of life, and exocrine function and structure
This study will determine if the study drug (pioglitazone) improves pre-diabetes (insulin resistance) or early diabetes and improves clinical symptoms (pain) or laboratory evidence of chronic pancreatitis.
The investigator's goal 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.
- Age range: 18 to 75 years
- Gender: male & female
- Ethnicity: all
- Race: all
- Smoking: both smoking and non-smoking volunteers
- Medication: no restriction
- This study is seeking both healthy subjects and patients with specified condition.
- Other eligibility factors:
- Elevated fasting glucose, impaired glucose tolerance, or mild diabetes mellitus
- Diabetes drug treatment is allowed except for short-acting insulin, long-acting insulin more than 15 units daily, pioglitazone, rosiglitazone, orlistat, acarbose, miglitol, or voglibose.
- Normal stool fat levels
- Sobriety at least 2 months
- X-ray test showing chronic damage to the pancreas
Location of study visits: Ann Arbor
Compensation: You will be paid up to a total of $900 if you complete the study. In addition, you will be reimbursed at a rate of 55.5 cents per mile traveled on your round trip to and from Ann Arbor; that is, for each visit to the University of Michigan Health System for the purpose of participating in this study.
Principal Investigator: Matthew J. DiMagno, MD
Questions or referrals: Please contact Nara Wootten: telephone (734) 615-6723 or e-mail firstname.lastname@example.org.
This clinical study is sponsored by the National Institute of Alcohol Abuse and Alcoholism (NIAAA), the Michigan Institute for Clinical and Health Research (MICHR), the University of Michigan Office of Vice President for Research (OVPR), and the University of Michigan Department of Internal Medicine.