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

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.

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.

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.

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.

Time frame: 48 weeks

Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/

Time frame: 24, 48 weeks

Population: 1 participant on the placebo side was no longer participating at 48 weeks

standard BMI defined as mass in kilograms divided by height in meters squared

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

Population: Some participant data is missing from some weeks, due to incomplete forms in certain instances.

Mean number of hospitalizations within the prior 12 weeks

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

Population: Some participant data is missing from some weeks, due to incomplete forms in certain instances.

Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/

Time frame: 24, 48 weeks

Population: 1 participant on the placebo side was no longer participating at 48 weeks

Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/;

Time frame: 24 and 48 weeks

Population: 1 participant on the placebo side was no longer participating at 48 weeks

Mean days of missed work reported by participants in response to question asking about missed work since the last visit (12 weeks)

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

Population: Some participant data is missing from some weeks, due to incomplete forms in certain instances.

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

Time frame: 48 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)?

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

Population: Some participant data is missing from some weeks, due to incomplete forms in certain instances.

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)

Time frame: 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.

Time frame: 24, 48 weeks

Population: The 24 week data has two participants' data missing from each arm because it was not available.