Phase 2
N=25
Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality
Chronic Pancreatitis · Insulin Resistance · Normal or Mildly Abnormal Stool Fat Levels
Bottom Line
View on ClinicalTrials.gov: NCT00782795 ↗Enrolled (actual)
25
Serious AEs
24.0%
Results posted
Dec 2017
Primary outcome: Primary: Glucose Tolerance at 24 Weeks — 2; 4; 3; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pioglitazone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glucose Tolerance at 24 Weeks |
2; 4; 3; 4; 2; 8 | — |
| PRIMARY Glucose Tolerance at 48 Weeks |
2; 5; 2; 5; 2; 6 | — |
| PRIMARY Insulin Sensitivity Index for Glycemia at 24 Weeks |
0.26; 0.35 | — |
| PRIMARY Insulin Sensitivity Index for Glycemia at 48 Weeks. |
0.21; 0.36 | — |
| SECONDARY Beta-cell Function |
110.51; 120.59; 121.60; 120.68 | — |
| SECONDARY Insulin Resistance at 24 and 48 Weeks |
2.56; 2.27; 2.32; 2.42 | — |
| SECONDARY Pancreas Ultrasound Appearance |
4.5; 4.91 | — |
| SECONDARY Quality of Life |
67.74; 70.06; 66.0; 64.71 | — |
| SECONDARY Number and Percentage of Participants With Steatorrhea |
1; 5 | — |
| SECONDARY Pain |
19.38; 23.03; 26.32; 18.92; 22.88; 23.55 | — |
| SECONDARY Body Mass Index (BMI) |
28.02; 28.64; 25.56; 29.49; 28.55; 27.46 | — |
| SECONDARY Hospitalizations |
0; 0.06; 0.43; 0.06; 0.20; 0.07 | — |
| SECONDARY Missed Work |
0.50; 0; 0.71; 0.75; 0.20; 0.47 | — |
| SECONDARY Insulin Sensitivity (%S) |
45.39; 51.83; 48.12; 46.18 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00782795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.