Trial · NCT00782795

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

NCT00782795, Phase 2, Completed, University of Michigan; results first posted 2017-12-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality. Trials, record NCT00782795. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00782795

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality
NCT number: NCT00782795
Status: Completed
Phases: Phase 2
Enrollment: 64 participants, actual
Lead sponsor: University of Michigan
Conditions: Chronic Pancreatitis, Insulin Resistance, Normal or Mildly Abnormal Stool Fat Levels
Interventions: Pioglitazone, Placebo
First posted: 2008-10-31
Last updated: 2018-01-11
Results first posted: 2017-12-11

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Glucose Tolerance at 24 Weeks	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.
Primary	Glucose Tolerance at 48 Weeks	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.
Primary	Insulin Sensitivity Index for Glycemia at 24 Weeks	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.
Primary	Insulin Sensitivity Index for Glycemia at 48 Weeks.	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	Beta-cell Function	24, 48 weeks	Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/
Secondary	Insulin Resistance at 24 and 48 Weeks	24, 48 weeks	Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/
Secondary	Pancreas Ultrasound Appearance	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)
Secondary	Quality of Life	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.
Secondary	Number and Percentage of Participants With Steatorrhea	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
Secondary	Pain	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)?

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Glucose Tolerance at 24 Weeks	24 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Glucose Tolerance at 48 Weeks	48 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Insulin Sensitivity Index for Glycemia at 24 Weeks	24 weeks		numeric index	MEAN
PRIMARY	Insulin Sensitivity Index for Glycemia at 48 Weeks.	48 weeks		numeric index	MEAN
SECONDARY	Beta-cell Function	24, 48 weeks	1 participant on the placebo side was no longer participating at 48 weeks	Beta-cell function (%)	MEAN
SECONDARY	Insulin Resistance at 24 and 48 Weeks	24, 48 weeks	1 participant on the placebo side was no longer participating at 48 weeks	HOMA2-IR	MEAN
SECONDARY	Pancreas Ultrasound Appearance	48 weeks		units on a scale	MEDIAN
SECONDARY	Quality of Life	24, 48 weeks	The 24 week data has two participants' data missing from each arm because it was not available.	units on a scale	MEAN
SECONDARY	Number and Percentage of Participants With Steatorrhea	48 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Pain	12, 24, 36, 48 and 60 weeks	Some participant data is missing from some weeks, due to incomplete forms in certain instances.	units on a scale	MEAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group76

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Glucose Tolerance at 24 Weeks	Sugar Pill (Placebo)	Diabetes	2	Participants
Glucose Tolerance at 24 Weeks	Pioglitazone	Diabetes	4	Participants
Glucose Tolerance at 24 Weeks	Sugar Pill (Placebo)	Impaired Glucose Tolerance	3	Participants
Glucose Tolerance at 24 Weeks	Pioglitazone	Impaired Glucose Tolerance	4	Participants
Glucose Tolerance at 24 Weeks	Sugar Pill (Placebo)	Normal	2	Participants
Glucose Tolerance at 24 Weeks	Pioglitazone	Normal	8	Participants
Glucose Tolerance at 48 Weeks	Sugar Pill (Placebo)	Diabetes	2	Participants
Glucose Tolerance at 48 Weeks	Pioglitazone	Diabetes	5	Participants
Glucose Tolerance at 48 Weeks	Sugar Pill (Placebo)	Impaired Glucose Tolerance	2	Participants
Glucose Tolerance at 48 Weeks	Pioglitazone	Impaired Glucose Tolerance	5	Participants

1 to 10 of 76Source ClinicalTrials.gov

See all 76 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pioglitazone	17
Overall Study	STARTED	Sugar Pill (Placebo)	8
Overall Study	6 Weeks (1st Apptment)	Pioglitazone	16
Overall Study	6 Weeks (1st Apptment)	Sugar Pill (Placebo)	7
Overall Study	24 Week Appointment	Pioglitazone	16
Overall Study	24 Week Appointment	Sugar Pill (Placebo)	7
Overall Study	COMPLETED	Pioglitazone	16
Overall Study	COMPLETED	Sugar Pill (Placebo)	6
Overall Study	NOT COMPLETED	Pioglitazone	1
Overall Study	NOT COMPLETED	Sugar Pill (Placebo)	2

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	chronic vertigo exacerbation	Ear and labyrinth disorders	Pioglitazone	1	17
serious	chronic vertigo exacerbation	Ear and labyrinth disorders	Sugar Pill (Placebo)	0	8
serious	Abdominal Pain	Gastrointestinal disorders	Pioglitazone	3	17	8
serious	Abdominal Pain	Gastrointestinal disorders	Sugar Pill (Placebo)	1	8	3
serious	Hyperglycemia	Endocrine disorders	Pioglitazone	0	17
serious	Hyperglycemia	Endocrine disorders	Sugar Pill (Placebo)	1	8
serious	Trauma to head	Nervous system disorders	Pioglitazone	1	17
serious	Trauma to head	Nervous system disorders	Sugar Pill (Placebo)	0	8
serious	Pneumonia	Respiratory, thoracic and mediastinal disorders	Pioglitazone	1	17
serious	Pneumonia	Respiratory, thoracic and mediastinal disorders	Sugar Pill (Placebo)	0	8

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pioglitazone
Total, all-cause mortality	Sugar Pill (Placebo)
Total, other adverse events	Pioglitazone	0	17
Total, other adverse events	Sugar Pill (Placebo)	0	8
Total, serious adverse events	Pioglitazone	4	17
Total, serious adverse events	Sugar Pill (Placebo)	2	8

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R21AA017271	Pioglitazone Therapy for Endocrine and Exocrine Disease in Alcoholic Pancreatitis	DIMAGNO, MATTHEW J	UNIVERSITY OF MICHIGAN AT ANN ARBOR	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	2008 to 2009

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Pioglitazone vs Sugar Pill (Placebo): Number and Percentage of Participants With Steatorrhea	Trial comparisons
Pioglitazone vs Sugar Pill (Placebo): serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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