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Trial record 6 of 26 for:    Open Studies | "Pancreatitis, Chronic"
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Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality

This study is currently recruiting participants.
Verified December 2012 by University of Michigan
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Dr. DiMagno, University of Michigan
ClinicalTrials.gov Identifier:
NCT00782795
First received: October 29, 2008
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  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:

U.S. FDA Resources

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: June 2013
Estimated Primary Completion Date: June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782795

Contacts
Contact: Nara Wootten, BS, CCRP 734.615.6723 smao@med.umich.edu

Locations
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Nara Wootten, BS     734-615-6723     smao@med.umich.edu    
Principal Investigator: Matthew DiMagno, M.D.            
Sponsors and Collaborators
University of Michigan
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Matthew DiMagno, M.D. University of Michigan Health System
  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: December 17, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
Chronic pancreatitis
Insulin resistance

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

ClinicalTrials.gov processed this record on May 22, 2013