NCT05197920 Diabetes RElated to Acute Pancreatitis and Its Mechanisms
| NCT ID | NCT05197920 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Milton S. Hershey Medical Center |
| Condition | Acute Pancreatitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2022-01-14 |
| Primary Completion | 2030-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2022-01-14 with a primary completion date of 2030-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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
Contact & Investigator
Vernon M Chinchilli, PhD
PRINCIPAL INVESTIGATOR
Penn State College of Medicine
Frequently Asked Questions
Who can join the NCT05197920 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Acute Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05197920 currently recruiting?
Yes, NCT05197920 is actively recruiting participants. Contact the research team at mbutt1@pennstatehealth.psu.edu for enrollment information.
Where is the NCT05197920 trial being conducted?
This trial is being conducted at Los Angeles, United States, Los Angeles, United States, Stanford, United States, Gainesville, United States and 9 additional locations.
Who is sponsoring the NCT05197920 clinical trial?
NCT05197920 is sponsored by Milton S. Hershey Medical Center. The principal investigator is Vernon M Chinchilli, PhD at Penn State College of Medicine. The trial plans to enroll 800 participants.