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| ID | Type | Description | Link |
|---|---|---|---|
| R21AA017271 | U.S. NIH Grant/Contract | View source | |
| 1R21AA017271-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| Takeda Pharmaceuticals North America, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone | Active Comparator | 30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks. |
|
| sugar pill (placebo) | Placebo Comparator | 1 sugar pill (placebo) taken once daily for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | Participants randomized to pioglitazone receive 30 mg taken once daily for 48 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Glucose Tolerance at 24 Weeks |
| 24 weeks |
| Glucose Tolerance at 48 Weeks |
| 48 weeks |
| Insulin Sensitivity Index for Glycemia at 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. | 24 weeks |
| Insulin Sensitivity Index for Glycemia at 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. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Beta-cell Function | Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/ | 24, 48 weeks |
| Insulin Resistance at 24 and 48 Weeks | Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/ |
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Inclusion Criteria:
Exclusion Criteria:
Mentally disabled patients
Women who are planning pregnancy, pregnant or lactating/nursing
Chronic pancreatitis is due to other specific conditions
Surgical resection of the head of the pancreas
Alcohol consumption within prior 2 months
Specific medical conditions
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.
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| Name | Affiliation | Role |
|---|---|---|
| Matthew DiMagno, M.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
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39 screen fails did not go on to randomization
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| ID | Title | Description |
|---|---|---|
| FG000 | Pioglitazone | 30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks. Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks. |
| FG001 | Sugar Pill (Placebo) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug |
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| 24, 48 weeks |
| Pancreas Ultrasound Appearance | Mean score on a scale of 0 - 10: count of positive Endoscopic Ultrasound(EUS) features: Parenchymal Features - Only Body and Tail
| 48 weeks |
| Quality of Life | 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. | 24, 48 weeks |
| Number and Percentage of Participants With Steatorrhea | 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 | 48 weeks |
| Pain | Pain is reported as the mean of four Visual analogue scales, ranging from 0 points (no pain) to 100 points (severe pain)
| 12, 24, 36, 48 and 60 weeks |
| Body Mass Index (BMI) | standard BMI defined as mass in kilograms divided by height in meters squared | 12, 24, 36, 48 and 60 weeks |
| Hospitalizations | Mean number of hospitalizations within the prior 12 weeks | 12, 24, 36, 48 and 60 weeks |
| Missed Work | Mean days of missed work reported by participants in response to question asking about missed work since the last visit (12 weeks) | 12, 24, 36, 48, 60 weeks |
| Insulin Sensitivity (%S) | Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/; | 24 and 48 weeks |
1 sugar pill (placebo) taken once daily for 48 weeks. Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks. |
| 6 Weeks (1st Apptment) |
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| 24 Week Appointment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pioglitazone | 30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks. Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks. |
| BG001 | Sugar Pill (Placebo) | 1 sugar pill (placebo) taken once daily for 48 weeks. Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glucose Tolerance at 24 Weeks |
| Posted | Count of Participants | Participants | 24 weeks |
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| Primary | Glucose Tolerance at 48 Weeks |
| Posted | Count of Participants | Participants | 48 weeks |
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| Primary | Insulin Sensitivity Index for Glycemia at 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. | Posted | Mean | Standard Deviation | numeric index | 24 weeks |
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| Primary | Insulin Sensitivity Index for Glycemia at 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. | Posted | Mean | Standard Deviation | numeric index | 48 weeks |
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| Secondary | Beta-cell Function | Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/ | 1 participant on the placebo side was no longer participating at 48 weeks | Posted | Mean | Standard Deviation | Beta-cell function (%) | 24, 48 weeks |
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| Secondary | Insulin Resistance at 24 and 48 Weeks | Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/ | 1 participant on the placebo side was no longer participating at 48 weeks | Posted | Mean | Standard Deviation | HOMA2-IR | 24, 48 weeks |
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| Secondary | Pancreas Ultrasound Appearance | Mean score on a scale of 0 - 10: count of positive Endoscopic Ultrasound(EUS) features: Parenchymal Features - Only Body and Tail
| Posted | Median | Inter-Quartile Range | units on a scale | 48 weeks |
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| Secondary | Quality of Life | 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. | The 24 week data has two participants' data missing from each arm because it was not available. | Posted | Mean | Standard Deviation | units on a scale | 24, 48 weeks |
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| Secondary | Number and Percentage of Participants With Steatorrhea | 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 | Posted | Count of Participants | Participants | 48 weeks |
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| Secondary | Pain | Pain is reported as the mean of four Visual analogue scales, ranging from 0 points (no pain) to 100 points (severe pain)
| Some participant data is missing from some weeks, due to incomplete forms in certain instances. | Posted | Mean | Standard Deviation | units on a scale | 12, 24, 36, 48 and 60 weeks |
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| Secondary | Body Mass Index (BMI) | standard BMI defined as mass in kilograms divided by height in meters squared | Some participant data is missing from some weeks, due to incomplete forms in certain instances. | Posted | Mean | Standard Deviation | kg/m^2 | 12, 24, 36, 48 and 60 weeks |
|
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| Secondary | Hospitalizations | Mean number of hospitalizations within the prior 12 weeks | Some participant data is missing from some weeks, due to incomplete forms in certain instances. | Posted | Mean | Standard Deviation | hospitalizations | 12, 24, 36, 48 and 60 weeks |
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| Secondary | Missed Work | Mean days of missed work reported by participants in response to question asking about missed work since the last visit (12 weeks) | Some participant data is missing from some weeks, due to incomplete forms in certain instances. | Posted | Mean | Standard Deviation | days | 12, 24, 36, 48, 60 weeks |
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| Secondary | Insulin Sensitivity (%S) | Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/; | 1 participant on the placebo side was no longer participating at 48 weeks | Posted | Mean | Standard Deviation | insulin sensitivity (%) | 24 and 48 weeks |
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48 weeks
All adverse events that participants raised to study team as such, all of which were reported on to the IRB, are shown below.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pioglitazone | 30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks. Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks. | 4 | 17 | 0 | 17 | ||
| EG001 | Sugar Pill (Placebo) | 1 sugar pill (placebo) taken once daily for 48 weeks. Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks. | 2 | 8 | 0 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| chronic vertigo exacerbation | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hyperglycemia | Endocrine disorders | Systematic Assessment |
| ||
| Trauma to head | Nervous system disorders | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| non-specific neck swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew DiMagno | University of Michigan | mdimagno@umich.edu |
| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Normal |
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| Units | Counts |
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| Participants |
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