Diabetes RElated to Acute Pancreatitis and Its Mechanisms
ConditionAcute Pancreatitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorMilton S. Hershey Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients hospitalized for acute pancreatitis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
diabetes mellitus (DM) following a qualifying episode of acute pancreatitis (AP)
time to onset of DM during the 36-month longitudinal follow-up period
Time frame
any time during the 36-month longitudinal follow-up periodSecondary outcomes
1
PROMIS Global Health
Patient Reported Outcomes Measurement Information System (PROMIS) Global Health, converted to a t-score with a mean of 50 and a standard deviation of 10
Time frame
months 3, 12, 24, and 362
PROMIS Pain Intensity
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity, measured on an 11-point scale from 0 (no pain ) to 10 (worst pain imaginable)
Time frame
months 3, 12, 24, and 363
PROMIS-29 Physical Function
PROMIS-29 Physical Function, converted to a t-score with a mean of 50 and a standard deviation of 10
Time frame
months 3, 12, 24, and 364
PROMIS-29 Anxiety
PROMIS-29 Anxiety, converted to a t-score with a mean of 50 and a standard deviation of 10
Time frame
months 3, 12, 24, and 36Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Milton S. Hershey Medical Center
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Benaroya Research Institute
Collaborator
Cedars-Sinai Medical Center
Collaborator
University of Southern California
Collaborator
Indiana University
Collaborator
Johns Hopkins University
Collaborator
Ohio State University
Collaborator
Stanford University
Collaborator
University of Florida
Collaborator
AdventHealth
Collaborator
University of Illinois at Chicago
Collaborator
Northwestern University
Collaborator
University of Minnesota
Collaborator
University of Pittsburgh
Collaborator
Source ClinicalTrials.gov