Investigating diabetes after acute pancreatitis

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

This study is trying to see if having acute pancreatitis makes people more likely to develop diabetes later on and how that happens.

Quick facts

• Study type: Observational
• Enrollment: 800 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Milton S. Hershey Medical Center (Academic / other)
• Locations: 13 sites (Los Angeles, California and 12 other locations)
• Trial ID: NCT05197920 on ClinicalTrials.gov

What this trial studies

The DREAM project is a prospective longitudinal observational study aimed at understanding the incidence and mechanisms of diabetes mellitus following acute pancreatitis. Over 36 months, participants will undergo various metabolic tests, including oral glucose tolerance testing and mixed meal tolerance testing, to assess their glucose metabolism and pancreatic function. The study hypothesizes that acute pancreatitis increases the risk of diabetes and that ongoing beta cell damage may contribute to delayed onset of diabetes in affected individuals.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with acute pancreatitis within the last 90 days.

Not a fit: Patients with chronic pancreatitis or those hospitalized for less than 48 hours due to post-ERCP acute pancreatitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and management of diabetes that develops after acute pancreatitis.

How similar studies have performed: While the specific approach of this study is novel, related studies have explored the connection between pancreatitis and diabetes with varying degrees of success.

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

Where this trial is running

Los Angeles, California and 12 other locations

• University of Southern California — Los Angeles, California, United States (Recruiting)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
• Stanford University — Stanford, California, United States (Recruiting)
• University of Florida — Gainesville, Florida, United States (Recruiting)
• AdventHealth — Orlando, Florida, United States (Recruiting)
• Northwestern University — Chicago, Illinois, United States (Recruiting)
• University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)
• Indiana University — Indianapolis, Indiana, United States (Recruiting)
• Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
• University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
• Ohio State University — Columbus, Ohio, United States (Recruiting)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
• Benaroya Research Institute — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: Vernon M Chinchilli, PhD — Penn State College of Medicine
• Study coordinator: Melissa A Butt, DrPH

Conditions Acute Pancreatitis; Diabetes