Diabetes RElated to Acute Pancreatitis and Its Mechanisms

Launched by MILTON S. HERSHEY MEDICAL CENTER · Jan 14, 2022

Keywords

ClinConnect Summary

The DREAM clinical trial is looking at how diabetes can develop after someone has an episode of acute pancreatitis, which is a sudden inflammation of the pancreas. The study will last for three years and aims to understand how often this happens, what causes it, and how it affects the body. Researchers are currently recruiting participants who have been diagnosed with acute pancreatitis within the last 90 days. To join the study, individuals must be able to understand the study requirements and give their consent, and they will be involved in various follow-ups and tests throughout the study period.

Participants in the trial can expect to complete some questionnaires, have telephone interviews, and undergo metabolic testing. However, there are certain health conditions and recent medical procedures that may prevent someone from participating, such as having chronic pancreatitis or specific types of pancreatic surgery. If someone becomes pregnant during the study, they can still participate but will have adjusted assessments to ensure their safety. This trial aims to gather important information that could help improve the understanding and management of diabetes related to acute pancreatitis.

Gender

ALL

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