Diabetes RElated to Acute Pancreatitis and Its Mechanisms
NCT ID: NCT05197920
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
800 participants
OBSERVATIONAL
2022-01-14
2030-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Benaroya Research Institute
OTHER
Cedars-Sinai Medical Center
OTHER
University of Southern California
OTHER
Indiana University
OTHER
Johns Hopkins University
OTHER
Ohio State University
OTHER
Stanford University
OTHER
University of Florida
OTHER
AdventHealth
OTHER
University of Illinois at Chicago
OTHER
Northwestern University
OTHER
University of Minnesota
OTHER
University of Pittsburgh
OTHER
Milton S. Hershey Medical Center
OTHER
Responsible Party
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Vernon Michael Chinchilli
Distinguished Professor
Principal Investigators
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Vernon M Chinchilli, PhD
Role: PRINCIPAL_INVESTIGATOR
Penn State College of Medicine
Dhiraj Yadav, MD, MPH
Role: STUDY_CHAIR
University of Pittsburgh
Melena D Bellin, MD
Role: STUDY_CHAIR
University of Minnesota
Phillip A Hart, MD
Role: STUDY_CHAIR
Ohio State University
Locations
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University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University
Stanford, California, United States
University of Florida
Gainesville, Florida, United States
AdventHealth
Orlando, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
Ohio State University
Columbus, Ohio, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Benaroya Research Institute
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Public web site for the Type 1 Diabetes in Acute Pancreatitis Consortium
Other Identifiers
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Penn State College of Medicine
Identifier Type: -
Identifier Source: org_study_id
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