Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality - Full Text View

Sponsored by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00782795

Purpose

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
Alcoholic Chronic Pancreatitis Insulin Resistance Normal Stool Fat Levels Sobriety	Drug: Pioglitazone	Phase II

Drug Information available for: Insulin Pioglitazone Pioglitazone hydrochloride Ethanol

U.S. FDA Resources

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

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:

Oral glucose tolerance test. [ Time Frame: Weeks 0, 24, 48 ] [ Designated as safety issue: No ]
Insulin sensitivity index for glycemia [ Time Frame: Weeks 0, 24, 48 ] [ Designated as safety issue: No ]
Pancreatic function testing. [ Time Frame: Weeks 0, 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Insulin resistance, sensitivity & Beta-cell function [ Time Frame: Weeks 0, 24, 48 ] [ Designated as safety issue: No ]
Pancreas ultrasound appearance [ Time Frame: Weeks 0, 48 ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: Weeks 0, 24, 48 ] [ Designated as safety issue: No ]
Pain, BMI, ER visits, Hospitalizations, Missed work [ Time Frame: Weeks 0, 6, 12, 24, 36, 48, 60 ] [ Designated as safety issue: No ]

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
Pioglitazone: Active Comparator 30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.	Drug: Pioglitazone Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.
sugar pill (placebo): Placebo Comparator 1 sugar pill (placebo) taken once daily for 48 weeks.	Drug: Pioglitazone Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Insulin resistance
Symptoms of abdominal pain
Xray test showing damage to the pancreas
Normal stool fat levels

Exclusion Criteria:

Mentally disabled patients
Women who are planning pregnancy, pregnant or lactating/nursing
Chronic pancreatitis is due to causes other than alcohol
Surgical resection of the head of the pancreas
Alcohol consumption within prior 2 months
Specific medical conditions
- Gastric surgery
- Celiac sprue
- Crohns disease
- Heart failure
- Kidney failure
- Cirrhosis or liver disease
- Osteoporosis
- Blood clotting disorder
- Visual problems
- Low albumin
- Low BMI
Specific medications *Diabetes (glucose lowering) medications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782795

Contacts

Contact: Michelle K Atkinson

734615-6723

michcast@umich.edu

Locations

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.

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Matthew DiMagno, M.D.

University of Michigan Health System

More Information

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

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Alcohol
Chronic pancreatitis
Insulin resistance

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009