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

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ClinicalTrials.gov Identifier: NCT00782795
Recruitment Status : Completed
First Posted : October 31, 2008
Results First Posted : December 11, 2017
Last Update Posted : January 11, 2018
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Matthew DiMagno, MD, University of Michigan

October 29, 2008
October 31, 2008
September 19, 2017
December 11, 2017
January 11, 2018
November 2008
December 2013   (Final data collection date for primary outcome measure)
  • Glucose Tolerance at 24 Weeks [ Time Frame: 24 weeks ]
    1. Normal = normal plasma glucose and normal glucose tolerance (OGTT).
    2. Impaired category includes all non-diabetic participants with either a) Impaired fasting glucose = fasting plasma glucose >110 mg/dl and <126 mg/dl; or b) Impaired glucose intolerance = 2-hour plasma glucose (OGTT) >140 mg/dl and <200 mg/dl.
    3. Diabetes = fasting plasma glucose >126 mg/dl 2-hour (OGTT) plasma glucose >200 mg/dl.
  • Glucose Tolerance at 48 Weeks [ Time Frame: 48 weeks ]
    1. Normal = normal plasma glucose and normal glucose tolerance (OGTT).
    2. Impaired category includes all non-diabetic participants with either a) Impaired fasting glucose = fasting plasma glucose >110 mg/dl and <126 mg/dl; or b) Impaired glucose intolerance = 2-hour plasma glucose (OGTT) >140 mg/dl and <200 mg/dl.
    3. Diabetes = fasting plasma glucose >126 mg/dl 2-hour (OGTT) plasma glucose >200 mg/dl.
  • Insulin Sensitivity Index for Glycemia at 24 Weeks [ Time Frame: 24 weeks ]

    Insulin Sensitivity = Index for Glycemia (ISI gly) = 2 / ([INSp x GLYp] + 1).

    GLYp = Glycemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr glucose.

    INSp = Insulinemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr insulin.

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

    Insulin Sensitivity = Index for Glycemia (ISI gly) = 2 / ([INSp x GLYp] + 1).

    GLYp = Glycemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr glucose.

    INSp = Insulinemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr insulin.

  • Oral glucose tolerance test. [ Time Frame: Measures 1-2: week 0, 24, 48. Measure 3: week 0, 48 ]
  • Insulin sensitivity index for glycemia [ Time Frame: Measures 1-2: week 0, 24, 48. Measure 3: week 0, 48 ]
  • Pancreatic function testing. [ Time Frame: Measures 1-2: week 0, 24, 48. Measure 3: week 0, 48 ]
Complete list of historical versions of study NCT00782795 on ClinicalTrials.gov Archive Site
  • Beta-cell Function [ Time Frame: 24, 48 weeks ]
    Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/
  • Insulin Resistance at 24 and 48 Weeks [ Time Frame: 24, 48 weeks ]
    Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/
  • Pancreas Ultrasound Appearance [ Time Frame: 48 weeks ]

    Mean score on a scale of 0 - 10: count of positive Endoscopic Ultrasound(EUS) features:

    Parenchymal Features - Only Body and Tail

    1. Calcification (>3 hyperechoic foci >2 mm length & width with shadowing)
    2. Lobularity (>3 well-circumscribed, >5mm structures)
    3. Hyperechoic stranding (>3 hyperechoic lines >3mm in length, seen in > 2 different directions with respect to the imaged plane Parenchymal Features - Head, Body and Tail
    4. Cyst (>2 mm diameter anechoic round or oval structure)
    5. Hyperechoic foci (>3 reflectors, >3 mm long & wide, no shadowing) Ductal Features - Only Body and Tail
    6. Side Branch Dilation (>3 tubular, anechoic, >1 mm structures,Main pancreatic duct (MPD) connects)
    7. Irregular MPD contour (uneven and ectatic in its course)
    8. Hyperechoic MPD margin (hyperechoic in >50% of MPD)
    9. Dilation MPD (>3.5 mm body, >1.5 mm tail*) Ductal Features - Head, Body and Tail
    10. MPD calculi (hyperechoic foci with shadowing contained within MPD)
  • Quality of Life [ Time Frame: 24, 48 weeks ]
    The SF36 (Short Form with 36 questions) QoL scoring system has 36 questions, comprising two main dimensions (Physical Health and Mental Health), further divided by 8 independent scales (Physical functioning, Role-Physical, Bodily pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health). The scales for general health and mental health overlap components of both the two main dimensions (Physical Health and Mental Health). The scales, including the total score and dimensions are scored as a number between 0 and 100, where 0 represents lower limits of functioning and 100 is best functioning possible. Data reported is the average total score.
  • Number and Percentage of Participants With Steatorrhea [ Time Frame: 48 weeks ]
    Participants were counted as having steatorrhea if they had either a) positive qualitative fecal fat; or b) 72 hour quantitative fecal fat result with >7g fat in stool in 24hours
  • Pain [ Time Frame: 12, 24, 36, 48 and 60 weeks ]

    Pain is reported as the mean of four Visual analogue scales, ranging from 0 points (no pain) to 100 points (severe pain)

    1. What is your pain right now?
    2. What is your typical or average pain in the last 12 weeks?
    3. What is your pain level at its best in the last 12 weeks (how close to "0" does your pain get at its best)?
    4. What is your pain level at its worst in the last 12 weeks (how close to "0" does your pain get at its worst)?
  • Body Mass Index (BMI) [ Time Frame: 12, 24, 36, 48 and 60 weeks ]
    standard BMI defined as mass in kilograms divided by height in meters squared
  • Hospitalizations [ Time Frame: 12, 24, 36, 48 and 60 weeks ]
    Mean number of hospitalizations within the prior 12 weeks
  • Missed Work [ Time Frame: 12, 24, 36, 48, 60 weeks ]
    Mean days of missed work reported by participants in response to question asking about missed work since the last visit (12 weeks)
  • Insulin Sensitivity (%S) [ Time Frame: 24 and 48 weeks ]
    Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/;
  • Insulin resistance, sensitivity & Beta-cell function [ Time Frame: Measures 1-2: week 0, 24, 48. Measure 3: week 0, 48 ]
  • Pancreas Ultrasound Appearance [ Time Frame: Measures 1-2: week 0, 24, 48. Measure 3: week 0, 48 ]
  • Quality of Life, Pain, BMI, ER visits [ Time Frame: Measures 1-2: week 0, 24, 48. Measure 3: week 0, 48 ]
  • Hospitalizations, Missed work [ Time Frame: Measures 1-2: week 0, 24, 48. Measure 3: week 0, 48 ]
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.

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

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Chronic Pancreatitis
  • Insulin Resistance
  • Normal or Mildly Abnormal Stool Fat Levels
  • Drug: Pioglitazone
    Participants randomized to pioglitazone receive 30 mg taken once daily for 48 weeks.
    Other Name: Actos
  • Drug: Placebo
  • 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: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
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 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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00782795
CP-PENQEX-1R21AA017271
R21AA017271 ( U.S. NIH Grant/Contract )
1R21AA017271-01A1 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: No
Matthew DiMagno, MD, University of Michigan
University of Michigan
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Takeda Pharmaceuticals North America, Inc.
Principal Investigator: Matthew DiMagno, M.D. University of Michigan
University of Michigan
December 2017

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