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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00782795
• Date of registration: 29/10/2008
• Prospective Registration: Yes
• Primary sponsor: University of Michigan
• Public title: Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality
• Scientific title: Phase II Study of Chronic Pancreatitis and the Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality
• Date of first enrolment: November 2008
• Target sample size: 64
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00782795
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Matthew DiMagno, M.D.
• Affiliation: University of Michigan

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Pancreatitis

Insulin Resistance

Normal or Mildly Abnormal Stool Fat Levels

Intervention(s)

Drug: Placebo

Drug: Pioglitazone

Primary Outcome(s)

Glucose Tolerance at 48 Weeks [Time Frame: 48 weeks]

Glucose Tolerance at 24 Weeks [Time Frame: 24 weeks]

Insulin Sensitivity Index for Glycemia at 24 Weeks [Time Frame: 24 weeks]

Insulin Sensitivity Index for Glycemia at 48 Weeks. [Time Frame: 48 weeks]

Secondary Outcome(s)

Missed Work [Time Frame: 12, 24, 36, 48, 60 weeks]

Number and Percentage of Participants With Steatorrhea [Time Frame: 48 weeks]

Insulin Sensitivity (%S) [Time Frame: 24 and 48 weeks]

Body Mass Index (BMI) [Time Frame: 12, 24, 36, 48 and 60 weeks]

Pancreas Ultrasound Appearance [Time Frame: 48 weeks]

Pain [Time Frame: 12, 24, 36, 48 and 60 weeks]

Beta-cell Function [Time Frame: 24, 48 weeks]

Hospitalizations [Time Frame: 12, 24, 36, 48 and 60 weeks]

Insulin Resistance at 24 and 48 Weeks [Time Frame: 24, 48 weeks]

Quality of Life [Time Frame: 24, 48 weeks]

Secondary ID(s)

R21AA017271

1R21AA017271-01A1

CP-PENQEX-1R21AA017271

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Takeda Pharmaceuticals North America, Inc.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Results

• Results available: Yes
• Date Posted: 11/12/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00782795