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Completed

NCT Number: NCT00782795

Chronic Pancreatitis. 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.

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Key information

Conditions

Chronic Pancreatitis Chronic Disease Digestive System Diseases Disease Attributes Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Normal or Mildly Abnormal Stool Fat Levels Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pioglitazone

Drug

Participants randomized to pioglitazone receive 30 mg taken once daily for 48 weeks.

Other names: Actos

Placebo

Drug

Primary outcomes

  1. Glucose Tolerance at 24 Weeks

    Time frame: 24 weeks

    • Normal = normal plasma glucose and normal glucose tolerance (OGTT).
    • 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.
    • Diabetes = fasting plasma glucose >126 mg/dl 2-hour (OGTT) plasma glucose >200 mg/dl.

  2. Glucose Tolerance at 48 Weeks

    Time frame: 48 weeks

    • Normal = normal plasma glucose and normal glucose tolerance (OGTT).
    • 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.
    • Diabetes = fasting plasma glucose >126 mg/dl 2-hour (OGTT) plasma glucose >200 mg/dl.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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/

  2. 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/

  3. 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

    • Calcification (>3 hyperechoic foci >2 mm length & width with shadowing)
    • Lobularity (>3 well-circumscribed, >5mm structures)
    • 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
    • Cyst (>2 mm diameter anechoic round or oval structure)
    • Hyperechoic foci (>3 reflectors, >3 mm long & wide, no shadowing) Ductal Features - Only Body and Tail
    • Side Branch Dilation (>3 tubular, anechoic, >1 mm structures,Main pancreatic duct (MPD) connects)
    • Irregular MPD contour (uneven and ectatic in its course)
    • Hyperechoic MPD margin (hyperechoic in >50% of MPD)
    • Dilation MPD (>3.5 mm body, >1.5 mm tail*) Ductal Features - Head, Body and Tail
    • MPD calculi (hyperechoic foci with shadowing contained within MPD)

  4. 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.

  5. 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

  6. 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)

    • What is your pain right now?
    • What is your typical or average pain in the last 12 weeks?
    • What is your pain level at its best in the last 12 weeks (how close to "0" does your pain get at its best)?
    • What is your pain level at its worst in the last 12 weeks (how close to "0" does your pain get at its worst)?

  7. 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

  8. Hospitalizations

    Time frame: 12, 24, 36, 48 and 60 weeks

    Mean number of hospitalizations within the prior 12 weeks

  9. 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)

  10. 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/;

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Takeda Pharmaceuticals North America, Inc.

Registry information

Official study title

Phase II Study of Chronic Pancreatitis and the Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Oct 31, 2008
Registry last updated
Jan 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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