DREAM

What is the Purpose of this Study?

This study focuses on individuals who have recently had an acute pancreatitis attack. The purpose of the study is to determine how many people with acute pancreatitis develop diabetes. Risk factors for diabetes and the types of diabetes that occur after acute pancreatitis will also be studied. A small number of people who already had diabetes before their acute pancreatitis attack will be enrolled for comparison. The study includes a screening/enrollment visit, metabolic visit and 5-year follow-up period.

Eligibility

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

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

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

STUDY00001575: Diabetes RElated to Acute pancreatitis and its Mechanisms

Study Details

Disease Type/Condition

Pancreatic Diseases

Principal Investigator

Goodarzi, Mark

Co-Investigators

Christie Jeon, Stephen Pandol

Age Group

Adult

Phase

N/A

IRB Number

STUDY00001575

ClinicalTrials.gov ID

NCT05197920

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org