What this study is
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).
Study details
- 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)
- Sponsor
- Milton S. Hershey Medical Center
- Conditions
- Acute Pancreatitis
- Enrolling
- 800 people
- Starts
- 2022-01-14
- Est. completion
- 2030-01-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (13)
13 openUniversity of Southern California
Los Angeles, California, United States
- Jessica Serna · Contact323-409-6939sernaj@usc.edu
- James L Buxbaum, MD · Principal investigator
RecruitingCedars-Sinai Medical Center
Los Angeles, California, United States
- Eleanor Chang · Contact310-423-0747eleanor.chang@cshs.org
- Mark O Goodarzi, MD, PhD · Principal investigator
- Stephen J Pandol, MD · Principal investigator
RecruitingStanford University
Stanford, California, United States
- Lorena Pineda · Contact650-723-4519ljpineda@stanford.edu
- Walter Park, MD · Principal investigator
- Marina Basina, MD · Principal investigator
RecruitingUniversity of Florida
Gainesville, Florida, United States
- Amber Bouton · Contact352-273-9774amber.bouton@surgery.ufl.edu
- Chris Forsmark, MD · Principal investigator
- Steven J Hughes, MD · Principal investigator
RecruitingAdventHealth
Orlando, Florida, United States
- Gina Mercouffer · Contact407-303-7106Gina.Mercouffer@adventHealth.com
- Richard E Pratley, MD · Principal investigator
RecruitingNorthwestern University
Chicago, Illinois, United States
- Christine Nelson · Contact312-695-4513c-ebert@northwestern.edu
- Rajesh N Keswani, MD, MS · Principal investigator
RecruitingUniversity of Illinois at Chicago
Chicago, Illinois, United States
- Haya Al Rashdan · Contact312-413-0306halras2@uic.edu
- Cemal Yazici, MD, MSc · Principal investigator
- Brian Layden, MD · Principal investigator
RecruitingIndiana University
Indianapolis, Indiana, United States
- Maureen Mullen-Montagano · Contact317-274-7677maamulle@iu.edu
- Evan L Fogel, MD · Principal investigator
- Carmella Evans-Molina, MD, PhD · Principal investigator
RecruitingJohns Hopkins University
Baltimore, Maryland, United States
- Mahya Faghih · Contact443-287-4680mfaghih2@jhu.edu
- Vikesh Singh, MD, MSc · Principal investigator
- Zhaoli Sun, MD, PhD · Principal investigator
RecruitingUniversity of Minnesota
Minneapolis, Minnesota, United States
- Heather Hodgkins · Contact612-626-5293Hodg0007@umn.edu
- Melena D Bellin, MD · Principal investigator
- Guru Trikudanathan, MD · Principal investigator
RecruitingOhio State University
Columbus, Ohio, United States
- Zoe Krebs · Contact614-685-6374Zoe.krebs@osumc.edu
- Phillip A Hart, MD · Principal investigator
- Georgios Papchristou, MD, PhD · Principal investigator
RecruitingUniversity of Pittsburgh
Pittsburgh, Pennsylvania, United States
- Shari Reynolds · Contact412-383-0570Reynoldss12@upmc.edu
- Dhiraj Yadav, MD, MPH · Principal investigator
- Frederico GS Toledo, MD · Principal investigator
RecruitingBenaroya Research Institute
Seattle, Washington, United States
- Kim Varner · Contact206-341-8936kvarner@benaroyaresearch.org
- Carla J Greenbaum, MD · Principal investigator
- Richard A Kozarek, MD · Principal investigator
Recruiting
Study team
Sponsor
Milton S. Hershey Medical Center
Study ID Penn State College of Medicine
Principal investigator
Vernon M Chinchilli, PhD
Penn State College of Medicine
Study chair
Dhiraj Yadav, MD, MPH
University of Pittsburgh
Study chair
Melena D Bellin, MD
University of Minnesota
Study chair
Phillip A Hart, MD
Ohio State University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.