Status:
COMPLETED
Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Takeda Pharmaceuticals North America, Inc.
Conditions:
Chronic Pancreatitis
Insulin Resistance
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 evid...
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 nu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00782795
Start Date
November 1 2008
End Date
December 1 2013
Last Update
January 11 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109