RECRUITING

Diabetes RElated to Acute Pancreatitis and Its Mechanisms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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)

Quick Facts

Study Start:2022-01-14

Study Completion:2025-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05197920

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Melissa A Butt, DrPH

CONTACT

717-531-1258

mbutt1@pennstatehealth.psu.edu

Kendall T Baab, BS

CONTACT

717-531-6308

kthomas4@pennstatehealth.psu.edu

Principal Investigator

Vernon M Chinchilli, PhD

PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Dhiraj Yadav, MD, MPH

STUDY_CHAIR

University of Pittsburgh

Melena D Bellin, MD

STUDY_CHAIR

University of Minnesota

Phillip A Hart, MD

STUDY_CHAIR

Ohio State University

Study Locations (Sites)

University of Southern California

Los Angeles, California, 90033

United States

Cedars-Sinai Medical Center

Los Angeles, California, 90048

United States

Stanford University

Stanford, California, 94305

United States

University of Florida

Gainesville, Florida, 32610-0214

United States

AdventHealth

Orlando, Florida, 32804

United States

Northwestern University

Chicago, Illinois, 60611

United States

University of Illinois at Chicago

Chicago, Illinois, 60612

United States

Indiana University

Indianapolis, Indiana, 46202

United States

Johns Hopkins University

Baltimore, Maryland, 21205

United States

University of Minnesota

Minneapolis, Minnesota, 55454

United States

Ohio State University

Columbus, Ohio, 43210

United States

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213

United States

Benaroya Research Institute

Seattle, Washington, 98101

United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

Vernon M Chinchilli, PhD, PRINCIPAL_INVESTIGATOR, Penn State College of Medicine
Dhiraj Yadav, MD, MPH, STUDY_CHAIR, University of Pittsburgh
Melena D Bellin, MD, STUDY_CHAIR, University of Minnesota
Phillip A Hart, MD, STUDY_CHAIR, Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-14

Study Completion Date2025-04-30

Study Record Updates

Study Start Date2022-01-14

Study Completion Date2025-04-30

Terms related to this study

Keywords Provided by Researchers

Diabetes

Additional Relevant MeSH Terms

Acute Pancreatitis