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

October 29, 2008
September 19, 2013
November 2008
December 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • Oral glucose tolerance test. [ Time Frame: Measures 1-2: week 0, 24, 48. Measure 3: week 0, 48 ] [ Designated as safety issue: No ]
  • Insulin sensitivity index for glycemia [ Time Frame: Measures 1-2: week 0, 24, 48. Measure 3: week 0, 48 ] [ Designated as safety issue: No ]
  • Pancreatic function testing. [ Time Frame: Measures 1-2: week 0, 24, 48. Measure 3: week 0, 48 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00782795 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Insulin resistance, sensitivity & Beta-cell function [ Time Frame: Measures 1-2: week 0, 24, 48. Measure 3: week 0, 48 ] [ Designated as safety issue: No ]
  • Pancreas ultrasound appearance [ Time Frame: Measures 1-2: week 0, 24, 48. Measure 3: week 0, 48 ] [ Designated as safety issue: No ]
  • Quality of Life, Pain, BMI, ER visits [ Time Frame: Measures 1-2: week 0, 24, 48. Measure 3: week 0, 48 ] [ Designated as safety issue: No ]
  • Hospitalizations, Missed work [ Time Frame: Measures 1-2: week 0, 24, 48. Measure 3: week 0, 48 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality
Phase II Study of Chronic Pancreatitis and the Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Chronic Pancreatitis
  • Insulin Resistance
  • Normal Stool Fat Levels
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
  • Active Comparator: Pioglitazone
    30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.
    Intervention: Drug: Pioglitazone
  • Placebo Comparator: sugar pill (placebo)
    1 sugar pill (placebo) taken once daily for 48 weeks.
    Intervention: Drug: Pioglitazone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00782795
CP-PENQEX-1R21AA017271, R21AA017271, 1R21AA017271-01A1
Yes
Dr. DiMagno, University of Michigan
University of Michigan
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Matthew DiMagno, M.D. University of Michigan
University of Michigan
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP