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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dr. DiMagno, University of Michigan
ClinicalTrials.gov Identifier:
NCT00782795
First received: October 29, 2008
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Chronic Pancreatitis
Insulin Resistance
Normal Stool Fat Levels
Drug: Pioglitazone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Study of Chronic Pancreatitis and the Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Oral glucose tolerance test. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Insulin sensitivity index for glycemia [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Oral glucose tolerance test [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Insulin sensitivity index for glycemia [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin resistance, sensitivity & Beta-cell function [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Pancreas ultrasound appearance [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Pain, BMI, ER visits, Hospitalizations, Missed work [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • Pancreatic Function Test [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Insulin resistance, sensitivity, & Beta-cell function [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Pain, BMI, ER visits, Hospitalization, Missed Work [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • Pain, BMI, ER visits, Hospitalization, Missed Work [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Pain, BMI, ER visits, Hospitalizations, Missed work [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Pain, BMI, ER visits, Hospitalization, Missed work [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Pain, BMI, ER visits, Hospitalization, Missed work [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pioglitazone
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.
Other Name: Actos
Placebo Comparator: sugar pill (placebo)
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.
Other Name: Actos

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 or mild diabetes mellitus
  • 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Matthew DiMagno, M.D. University of Michigan
  More Information

No publications provided

Responsible Party: Dr. DiMagno, Assistant Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT00782795     History of Changes
Other Study ID Numbers: CP-PENQEX-1R21AA017271, R21AA017271, 1R21AA017271-01A1
Study First Received: October 29, 2008
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
Chronic pancreatitis
Insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Pancreatitis
Pancreatitis, Chronic
Digestive System Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Pancreatic Diseases
Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 19, 2014