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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Michigan
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); Takeda Pharmaceuticals North America, Inc.
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

• Insulin resistance or mild diabetes mellitus

• Symptoms of abdominal pain

• Xray test showing damage to the pancreas

• Normal or mildly abnormal stool fat levels

Exclusion Criteria:

• Mentally disabled patients

• Women who are planning pregnancy, pregnant or lactating/nursing

• Chronic pancreatitis is due to other specific conditions

• Autosomal dominant pancreatitis

• Classic cystic fibrosis with lung involvement

• Autoimmune pancreatitis

• Pancreatic cancer

• Biliary obstruction (non-pancreatic cause)

• Abdominal trauma

• Hypercalcemia

• Hypertriglyceridemia

• 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 drug treatment is allowed except for short-acting insulin, long-acting insule more than 15 units daily, pioglitazone, rosiglitazone, orlistat, acarbose, miglitol or voglibose.