Diabetes RElated to Acute Pancreatitis and Its Mechanisms (DREAM)

Diabetes RElated to Acute Pancreatitis and Its Mechanisms (DREAM) An Observational Cohort Study From the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC)

The overriding objective of DREAM is to conduct a prospective longitudinal (36 months) observational clinical study to investigate the incidence, etiology, and pathophysiology of diabetes mellitus (DM) following acute pancreatitis (AP).

Study Overview

• Status: Recruiting
• Conditions: Acute Pancreatitis

Detailed Description

The DREAM investigators will conduct dynamic metabolic testing that includes oral glucose tolerance testing (OGTT), mixed meal tolerance testing (MMTT), and frequently sampled intravenous glucose tolerance testing (FSIGTT). These tests will increase the sensitivity for DM diagnosis (with OGTT) and to assess beta cell function and other pancreatic and enteroendocrine hormones involved in maintaining glucose homeostasis (OGTT, MMTT and FSIGTT). The DREAM research hypotheses are as follows.

1. There is a cumulative increase in the risk of any type of DM after an episode of AP, and the development of DM after AP is influenced by several patient and disease-related factors (e.g. age, etiology, disease severity).
2. After AP is clinically resolved, there is ongoing subclinical beta cell damage that predisposes to delayed-onset of DM.
3. AP triggers an altered immune state in a subset of individuals that predisposes to islet autoimmunity and DM.

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Melissa A Butt, DrPH; Phone Number: 717-531-1258; Email: mbutt1@pennstatehealth.psu.edu
• Study Contact Backup: Name: Kendall T Baab, BS; Phone Number: 717-531-6308; Email: kthomas4@pennstatehealth.psu.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Eleanor Chang; Phone Number: 310-423-0747; Email: eleanor.chang@cshs.org
      • Principal Investigator: Mark O Goodarzi, MD, PhD
      • Principal Investigator: Stephen J Pandol, MD
    • Los Angeles, California, United States, 90033
      • Recruiting
      • University of Southern California
      • Contact: Jessica Serna; Phone Number: 323-409-6939; Email: sernaj@usc.edu
      • Principal Investigator: James L Buxbaum, MD
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Principal Investigator: Walter Park, MD
      • Principal Investigator: Marina Basina, MD
      • Contact: Lorena Pineda; Phone Number: 650-723-4519; Email: ljpineda@stanford.edu
  • Florida
    • Gainesville, Florida, United States, 32610-0214
      • Recruiting
      • University of Florida
      • Contact: Amber Bouton; Phone Number: 352-273-9774; Email: amber.bouton@surgery.ufl.edu
      • Principal Investigator: Chris Forsmark, MD
      • Principal Investigator: Steven J Hughes, MD
    • Orlando, Florida, United States, 32804
      • Recruiting
      • AdventHealth
      • Contact: Gina Mercouffer; Phone Number: 407-303-7106; Email: gina.mercouffer@adventhealth.com
      • Principal Investigator: Richard E Pratley, MD
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Christine Nelson; Phone Number: 312-695-4513; Email: c-ebert@northwestern.edu
      • Principal Investigator: Rajesh N Keswani, MD, MS
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois at Chicago
      • Contact: Haya Al Rashdan; Phone Number: 312-413-0306; Email: halras2@uic.edu
      • Principal Investigator: Cemal Yazici, MD, MSc
      • Principal Investigator: Brian Layden, MD
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University
      • Contact: Maureen Mullen-Montagano; Phone Number: 317-274-7677; Email: maamulle@iu.edu
      • Principal Investigator: Evan L Fogel, MD
      • Principal Investigator: Carmella Evans-Molina, MD, PhD
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Johns Hopkins University
      • Contact: Mahya Faghih; Phone Number: 443-287-4680; Email: mfaghih2@jhu.edu
      • Principal Investigator: Vikesh Singh, MD, MSc
      • Principal Investigator: Zhaoli Sun, MD, PhD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • Recruiting
      • University of Minnesota
      • Contact: Heather Hodgkins; Phone Number: 612-626-5293; Email: hodg0007@umn.edu
      • Principal Investigator: Melena D Bellin, MD
      • Principal Investigator: Guru Trikudanathan, MD
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
      • Principal Investigator: Phillip A Hart, MD
      • Principal Investigator: Georgios Papchristou, MD, PhD
      • Contact: Zoe Krebs; Phone Number: 614-685-6374; Email: zoe.krebs@osumc.edu
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh
      • Contact: Shari Reynolds; Phone Number: 412-383-0570; Email: reynoldss12@upmc.edu
      • Principal Investigator: Dhiraj Yadav, MD, MPH
      • Principal Investigator: Frederico GS Toledo, MD
  • Washington
    • Seattle, Washington, United States, 98101
      • Recruiting
      • Benaroya Research Institute
      • Contact: Kim Varner; Phone Number: 206-341-8936; Email: kvarner@benaroyaresearch.org
      • Principal Investigator: Carla J Greenbaum, MD
      • Principal Investigator: Richard A Kozarek, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized for acute pancreatitis

Description

Inclusion Criteria:

• Diagnosis of acute pancreatitis (AP) 0-90 days prior to enrollment date
• Participant fully understands and is able to participate in all aspects of the study, including providing informed consent, completion of case report forms (CRFs), telephone interviews, metabolic testing, and planned longitudinal follow-ups

Exclusion Criteria:

• Diagnosis of definite chronic pancreatitis (CP) at enrollment based on either of the following criteria met by computed tomography (CT) scan (including non-contrast enhanced) or Magnetic resonance Imaging (MRI) or Magnetic Resonance Cholangiopancreatography (MRCP): (a) Parenchymal or ductal calcifications on CT scan (after excluding the possibility that calcifications are vascular); (b) Intraductal filling defects suggestive of calcifications on MRI and/or MRCP
• Potential participants with post-endoscopic retrograde cholangiopancreatography (post- ERCP) AP who are hospitalized for <48 hours.
• Prior (i.e., before enrollment) direct endoscopic necrosectomy of the pancreas or percutaneous necrosectomy or drainage of necrotic collection(s). Participants who require this during follow-up will remain in the study
• Pancreatic tumors, including ductal adenocarcinoma, neuroendocrine tumors, and metastasis
• Confirmed or suspected cystic tumor associated with main pancreatic duct dilation, or believed to be the cause of AP (in the site-PI's judgement)
• Prior pancreatic surgery, including, but not limited to: distal pancreatectomy, pancreaticoduodenectomy, pancreatic necrosectomy, Frey procedure
• Use of disallowed concomitant medications within 30 days prior to enrollment. A comprehensive list of disallowed medications will be included and routinely updated in the study's Manual of Procedures
• Severe systemic illness that in the judgement of the investigative team will confound outcome assessments of DM and immunological outcomes or pose additional risk for harms, including: history of solid organ transplant, acquired immunodeficiency syndrome (AIDS), active treatment for cancer (except non-melanoma skin cancer) within 12 months prior to enrollment, chronic kidney disease with estimate glomerular filtration rate (eGFR) < 30 or on dialysis prior to AP, and cirrhosis (based on imaging or biopsy), or any other medical condition that in the opinion of the site-PI carries a life expectancy of <12 months.
• Known pregnancy at the time of enrollment. Participants who become pregnant during follow-up will remain in the study, but may have modified study assessments for safety
• Incarceration
• Any other condition or factor that would compromise the participant's safety or the scientific integrity of the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diabetes mellitus (DM) following a qualifying episode of acute pancreatitis (AP)	time to onset of DM during the 36-month longitudinal follow-up period	any time during the 36-month longitudinal follow-up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Global Health	Patient Reported Outcomes Measurement Information System (PROMIS) Global Health, converted to a t-score with a mean of 50 and a standard deviation of 10	months 3, 12, 24, and 36
PROMIS Pain Intensity	Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity, measured on an 11-point scale from 0 (no pain ) to 10 (worst pain imaginable)	months 3, 12, 24, and 36
PROMIS-29 Physical Function	PROMIS-29 Physical Function, converted to a t-score with a mean of 50 and a standard deviation of 10	months 3, 12, 24, and 36
PROMIS-29 Anxiety	PROMIS-29 Anxiety, converted to a t-score with a mean of 50 and a standard deviation of 10	months 3, 12, 24, and 36
PROMIS-29 Depression	PROMIS-29 Depression, converted to a t-score with a mean of 50 and a standard deviation of 10	months 3, 12, 24, and 36
PROMIS-29 Fatigue	PROMIS-29 Fatigue, converted to a t-score with a mean of 50 and a standard deviation of 10	months 3, 12, 24, and 36
PROMIS-29 Sleep Disturbance	PROMIS-29 Sleep Disturbance, converted to a t-score with a mean of 50 and a standard deviation of 10	months 3, 12, 24, and 36
PROMIS-29 Ability to Participate in Social Roles and Activities	PROMIS-29 Ability to Participate in Social Roles and Activities, converted to a t-score with a mean of 50 and a standard deviation of 10	months 3, 12, 24, and 36
PROMIS-29 Pain Interference	PROMIS-29 Pain Interference, converted to a t-score with a mean of 50 and a standard deviation of 10	months 3, 12, 24, and 36
OGTT Insulin Secretion	Oral Glucose Tolerance Testing (OGTT) Insulin Secretion, as measured by the insulin area under the curve relative to the glucose area under the curve	months 3, 12, 24, and 36
OGTT Insulin Sensitivity Index	Oral Glucose Tolerance Testing (OGTT) Insulin Sensitivity Index, as measured by the glucose disposal rate divided by the average plasma insulin concentration	months 3, 12, 24, and 36
MMTT Incretin Hormones: GIP and GLP-1	Mixed Meal Tolerance Testing (MMTT) Incretin Hormones: Glucose-dependent Insulinotropic Polypeptide (GIP, pmol/L) and Glucagon-like Peptide-1 (GLP-1, pmol/L)	months 3, 12, 24, and 36
MMTT Glucagon	Mixed Meal Tolerance Testing (MMTT) Glucagon (pg/mL)	months 3, 12, 24, and 36
MMTT Pancreatic Polypeptide (PP)	Mixed Meal Tolerance Testing (MMTT) Pancreatic Polypeptide (PP, pg/mL)	months 3, 12, 24, and 36
FSIGTT Acute Insulin Response to Glucose (AIRglu)	Frequently Sampled Intravenous Glucose Tolerance Testing (FSIGTT) Acute Insulin Response to Glucose (AIRglu)	months 3 and 12
FSIGTT Acute C-peptide Response to Glucose (ACRglu)	Frequently Sampled Intravenous Glucose Tolerance Testing (FSIGTT) Acute C-peptide Response to Glucose (ACRglu)	months 3 and 12
FSIGTT Total Body Insulin Sensitivity Index (SI)	Frequently Sampled Intravenous Glucose Tolerance Testing (FSIGTT) Total Body Insulin Sensitivity Index (SI)	months 3 and 12
FSIGTT Total Body Insulin Sensitivity Index (SI) Disposition Index	Frequently Sampled Intravenous Glucose Tolerance Testing (FSIGTT) Disposition Index (DI), calculated as the product of the AIRglu and the Total Body Insulin SI	months 3 and 12
Islet Autoantibodies	Islet Autoantibodies	months 3, 12, 24, and 36
Fecal Elastase	Fecal Elastase (ug/g)	months 3, 12, 24, and 36

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: Johns Hopkins University; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Northwestern University; University of Pittsburgh; University of Illinois at Chicago; University of Florida; University of Southern California; Stanford University; Ohio State University; University of Minnesota; Cedars-Sinai Medical Center; Indiana University; AdventHealth; Benaroya Research Institute
• Investigators: Principal Investigator: Vernon M Chinchilli, PhD, Penn State College of Medicine; Study Chair: Dhiraj Yadav, MD, MPH, University of Pittsburgh; Study Chair: Melena D Bellin, MD, University of Minnesota; Study Chair: Phillip A Hart, MD, Ohio State University

Publications and helpful links

Helpful Links

• Public web site for the Type 1 Diabetes in Acute Pancreatitis Consortium

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): January 31, 2030

Study Registration Dates

• First Submitted: December 11, 2021
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Estimated): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Pancreatic Diseases; Nutritional and Metabolic Diseases; Pancreatitis; Diabetes Mellitus
• Other Study ID Numbers: Penn State College of Medicine; U01DK127384 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from final locked datasets will be made available to other researchers outside the DREAM investigative team. The plan for data sharing incorporates a strategy that recognizes the importance of protecting participants' rights to individual privacy and is compliant with HIPAA regulations and NIH requirements (https://grants.nih.gov/grants/policy/data_sharing/).
• IPD Sharing Time Frame: The data will become available one year after publication of the primary manuscript of the DREAM study. The data will be available indefinitely at the NIDDK Central Repository.

IPD Sharing Access Criteria

Instructions for requesting data from the NIDDK Central Repository appear at the following web site:

https://repository.niddk.nih.gov/pages/overall_instructions/

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No