← Back to searchRecruitingRecruiting
Diabetes RElated to Acute Pancreatitis and Its Mechanisms
NCT05197920 · Milton S. Hershey Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Diabetes RElated to Acute Pancreatitis and Its Mechanisms (DREAM) An Observational Cohort Study From the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC)
About this study
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.
Eligibility criteria
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 target: 800 participants
Age groups: adult, older_adult
Timeline
Starts: 2022-01-14
Estimated completion: 2030-01-31
Last updated: 2025-11-18
Primary outcomes
- • diabetes mellitus (DM) following a qualifying episode of acute pancreatitis (AP) (any time during the 36-month longitudinal follow-up period)
Sponsor
Milton S. Hershey Medical Center · other
With: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Benaroya Research Institute, Cedars-Sinai Medical Center, University of Southern California, Indiana University, Johns Hopkins University, Ohio State University, Stanford University, University of Florida, AdventHealth, University of Illinois at Chicago, Northwestern University, University of Minnesota, University of Pittsburgh
Contacts & investigators
ContactMelissa A Butt, DrPH · contact · mbutt1@pennstatehealth.psu.edu · 717-531-1258
ContactKendall T Baab, BS · contact · kthomas4@pennstatehealth.psu.edu · 717-531-6308
InvestigatorVernon M Chinchilli, PhD · principal_investigator, Penn State College of Medicine
InvestigatorDhiraj Yadav, MD, MPH · study_chair, University of Pittsburgh
InvestigatorMelena D Bellin, MD · study_chair, University of Minnesota
All locations (13)
University of Southern CaliforniaRecruiting
Los Angeles, California, United States
Cedars-Sinai Medical CenterRecruiting
Los Angeles, California, United States
Stanford UniversityRecruiting
Stanford, California, United States
University of FloridaRecruiting
Gainesville, Florida, United States
AdventHealthRecruiting
Orlando, Florida, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
University of Illinois at ChicagoRecruiting
Chicago, Illinois, United States
Indiana UniversityRecruiting
Indianapolis, Indiana, United States
Johns Hopkins UniversityRecruiting
Baltimore, Maryland, United States
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
Ohio State UniversityRecruiting
Columbus, Ohio, United States
University of PittsburghRecruiting
Pittsburgh, Pennsylvania, United States
Benaroya Research InstituteRecruiting
Seattle, Washington, United States