Recruiting

Observational StudyDiabetes RElated to Acute Pancreatitis and Its Mechanisms

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT05197920

Conditions

Acute Pancreatitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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).

Conditions

Acute Pancreatitis

Study ID

NCT05197920

Start date

Jan 14, 2022

Status verified date

Nov, 2025

Completion date

Jan 31, 2030

Anticipated

Primary completion date

Jan 31, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

diabetes mellitus (DM) following a qualifying episode of acute pancreatitis (AP) [ Time Frame: any time during the 36-month longitudinal follow-up period ]

Central Contacts and Locations

Central contacts

Melissa A Butt, DrPH

717-531-1258 mbutt1@pennstatehealth.psu.edu

Kendall T Baab, BS

717-531-6308 kthomas4@pennstatehealth.psu.edu

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Jessica Serna

323-409-6939 sernaj@usc.edu

Principal Investigator:

James L Buxbaum, MD

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Eleanor Chang

310-423-0747 eleanor.chang@cshs.org

Principal Investigator:

Mark O Goodarzi, MD, PhD

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Lorena Pineda

650-723-4519 ljpineda@stanford.edu

Principal Investigator:

Walter Park, MD

University of Florida

Recruiting

Gainesville, Florida, United States, 32610-0214

Contacts

Amber Bouton

352-273-9774 amber.bouton@surgery.ufl.edu

Principal Investigator:

Chris Forsmark, MD

AdventHealth

Recruiting

Orlando, Florida, United States, 32804

Contacts

Gina Mercouffer

407-303-7106 Gina.Mercouffer@adventHealth.com

Principal Investigator:

Richard E Pratley, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Christine Nelson

312-695-4513 c-ebert@northwestern.edu

Principal Investigator:

Rajesh N Keswani, MD, MS

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Haya Al Rashdan

312-413-0306 halras2@uic.edu

Principal Investigator:

Cemal Yazici, MD, MSc

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Maureen Mullen-Montagano

317-274-7677 maamulle@iu.edu

Principal Investigator:

Evan L Fogel, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Mahya Faghih

443-287-4680 mfaghih2@jhu.edu

Principal Investigator:

Vikesh Singh, MD, MSc

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Heather Hodgkins

612-626-5293 Hodg0007@umn.edu

Principal Investigator:

Melena D Bellin, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Zoe Krebs

614-685-6374 Zoe.krebs@osumc.edu

Principal Investigator:

Phillip A Hart, MD

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Shari Reynolds

412-383-0570 Reynoldss12@upmc.edu

Principal Investigator:

Dhiraj Yadav, MD, MPH

Benaroya Research Institute

Recruiting

Seattle, Washington, United States, 98101

Contacts

Kim Varner

206-341-8936 kvarner@benaroyaresearch.org

Principal Investigator:

Carla J Greenbaum, MD

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

Nov 18, 2025

Last verified

Nov, 2025

Keywords

Diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2025-11-18.