Clinical trial NCT00782795: Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality
Official title: Phase II Study of Chronic Pancreatitis and the Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Pancreatitis
Insulin Resistance
Normal or Mildly Abnormal Stool Fat Levels
Keywords: Chronic pancreatitis
Insulin resistance
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Takeda Pharmaceuticals North America, Inc.
First posted: 2008-10-31
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Note: Takeda Pharmaceuticals North America (TPNA) provided pioglitazone and placebo pills with identically appearance until June 28, 2010, approximately the middle of the study.

Eligibility 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.

Primary outcomes:
measure: Glucose Tolerance at 24 Weeks
timeFrame: 24 weeks
measure: Glucose Tolerance at 48 Weeks
timeFrame: 48 weeks
measure: Insulin Sensitivity Index for Glycemia at 24 Weeks
timeFrame: 24 weeks
measure: Insulin Sensitivity Index for Glycemia at 48 Weeks.
timeFrame: 48 weeks
Secondary outcomes:
measure: Beta-cell Function
timeFrame: 24, 48 weeks
measure: Insulin Resistance at 24 and 48 Weeks
timeFrame: 24, 48 weeks
measure: Pancreas Ultrasound Appearance
timeFrame: 48 weeks
measure: Quality of Life
timeFrame: 24, 48 weeks
measure: Number and Percentage of Participants With Steatorrhea
timeFrame: 48 weeks
measure: Pain
timeFrame: 12, 24, 36, 48 and 60 weeks
measure: Body Mass Index (BMI)
timeFrame: 12, 24, 36, 48 and 60 weeks
measure: Hospitalizations
timeFrame: 12, 24, 36, 48 and 60 weeks
measure: Missed Work
timeFrame: 12, 24, 36, 48, 60 weeks
measure: Insulin Sensitivity (%S)
timeFrame: 24 and 48 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Matthew DiMagno, M.D.
role: PRINCIPAL_INVESTIGATOR
References: