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Sponsored by: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
ClinicalTrials.gov Identifier: | NCT00782795 |
The purpose of this study is to determine if drug treatment will improve pre-diabetes (insulin resistance) and improve clinical symptoms or laboratory evidence of chronic pancreatitis due to alcohol, the most common cause.
The investigators goal is to gather information from this study to help gain understanding of a potential therapy for chronic pancreatitis.
Condition | Intervention | Phase |
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Alcoholic Chronic Pancreatitis Insulin Resistance Normal Stool Fat Levels Sobriety |
Drug: Pioglitazone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Chronic Pancreatitis and the Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality |
Estimated Enrollment: | 60 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Pioglitazone: Active Comparator
30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.
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Drug: Pioglitazone
Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.
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sugar pill (placebo): Placebo Comparator
1 sugar pill (placebo) taken once daily for 48 weeks.
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Drug: Pioglitazone
Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Specific medical conditions
Contact: Michelle K Atkinson | 734615-6723 | michcast@umich.edu |
United States, Michigan | |
University of Michigan Health System | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Michelle K Atkinson 734-615-6723 michcast@umich.edu | |
Principal Investigator: Matthew DiMagno, M.D. |
Principal Investigator: | Matthew DiMagno, M.D. | University of Michigan Health System |
Responsible Party: | University of Michigan ( Matthew DiMagno, M.D. ) |
Study ID Numbers: | CP-PENQEX, 1R21AA017271-01A1 |
Study First Received: | October 29, 2008 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00782795 |
Health Authority: | United States: Federal Government |
Alcohol Chronic pancreatitis Insulin resistance |
Metabolic Diseases Pioglitazone Quality of Life Pain Insulin Hyperinsulinism Digestive System Diseases |
Pancreatic Diseases Insulin Resistance Glucose Metabolism Disorders Metabolic disorder Pancreatitis Pancreatitis, Chronic Ethanol |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |