Diabetes RElated to Acute Pancreatitis and Its Mechanisms


I'm Interested

Trial ID: NCT05197920


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).

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)

Stanford Investigator(s)

Walter Park
Walter Park

Associate Professor of Medicine (Gastroenterology and Hepatology)

Marina Basina
Marina Basina

Clinical Professor, Medicine - Endocrinology, Gerontology, & Metabolism

Vipul Sheth
Vipul Sheth

Assistant Professor of Radiology (Body MRI)


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

   - 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


I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Breanna Collins