Diabetes RElated to Acute Pancreatitis and Its Mechanisms
DREAM
2 other identifiers
observational
800
1 country
13
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2021
CompletedStudy Start
First participant enrolled
January 14, 2022
CompletedFirst Posted
Study publicly available on registry
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2030
November 18, 2025
November 1, 2025
8.1 years
December 11, 2021
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (20)
PROMIS Global Health
months 3, 12, 24, and 36
PROMIS Pain Intensity
months 3, 12, 24, and 36
PROMIS-29 Physical Function
months 3, 12, 24, and 36
PROMIS-29 Anxiety
months 3, 12, 24, and 36
PROMIS-29 Depression
months 3, 12, 24, and 36
- +15 more secondary outcomes
Eligibility Criteria
Patients hospitalized for acute pancreatitis
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Milton S. Hershey Medical Centerlead
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
- Benaroya Research Institutecollaborator
- Cedars-Sinai Medical Centercollaborator
- University of Southern Californiacollaborator
- Indiana Universitycollaborator
- Johns Hopkins Universitycollaborator
- Ohio State Universitycollaborator
- Stanford Universitycollaborator
- University of Floridacollaborator
- AdventHealthcollaborator
- University of Illinois at Chicagocollaborator
- Northwestern Universitycollaborator
- University of Minnesotacollaborator
- University of Pittsburghcollaborator
Study Sites (13)
University of Southern California
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Stanford University
Stanford, California, 94305, United States
University of Florida
Gainesville, Florida, 32610-0214, United States
AdventHealth
Orlando, Florida, 32804, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
University of Minnesota
Minneapolis, Minnesota, 55454, United States
Ohio State University
Columbus, Ohio, 43210, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Benaroya Research Institute
Seattle, Washington, 98101, United States
Related Links
Biospecimen
blood (fasting blood glucose, islet autoantibodies, creatinine, complete blood count (CBC), RNAseq), stool (fecal elastase)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished Professor
Study Record Dates
First Submitted
December 11, 2021
First Posted
January 20, 2022
Study Start
January 14, 2022
Primary Completion (Estimated)
January 31, 2030
Study Completion (Estimated)
January 31, 2030
Last Updated
November 18, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
- 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/
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/).