Investigating diabetes after acute pancreatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The DREAM project is a prospective longitudinal observational study aimed at understanding the incidence and mechanisms of diabetes mellitus following acute pancreatitis. Over 36 months, participants will undergo various metabolic tests, including oral glucose tolerance testing and mixed meal tolerance testing, to assess their glucose metabolism and pancreatic function. The study hypothesizes that acute pancreatitis increases the risk of diabetes and that ongoing beta cell damage may contribute to delayed onset of diabetes in affected individuals.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Southern California
  Los Angeles, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Stanford University
  Stanford, California, United States Recruiting
• University of Florida
  Gainesville, Florida, United States Recruiting
• AdventHealth
  Orlando, Florida, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Vernon M Chinchilli, PhD — Penn State College of Medicine
• Study coordinator: Melissa A Butt, DrPH
• Email: mbutt1@pennstatehealth.psu.edu
• Phone: 717-531-1258

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Local complications of acute pancreatitis and postoperative pancreatic fistula: what happens in real life

  This multicenter registry tests how local pancreatic complications are managed in routine care and what outcomes look like over 180 days for adults.

  Recruiting at 12 sites Tokyo University · Ōtsu, Shiga and 11 other locations · NCT07862088

• SGC001 is being tested to help predicted severe acute pancreatitis

  Researchers are testing SGC001 vs placebo in adults with predicted severe acute pancreatitis to see if it is safe and tolerable and to get a sense of any early effects.

  Recruiting Phase 2 Beijing Sungen Biomedical Technology Co., Ltd · Chengdu and 14 other locations · NCT07803965

• Fecal microbiota transplant to prevent infections after late-phase severe acute pancreatitis

  This trial will test whether giving healthy donor gut bacteria (fecal microbiota transplantation) through a feeding tube in the late phase of moderately severe or severe acute pancreatitis can prevent infectious complications.

  Recruiting Changhai Hospital · Fuzhou, Fujian and 11 other locations · NCT07464392

• How often splanchnic vein clots occur in acute pancreatitis and whether they relate to disease severity

  This project will see if people with acute pancreatitis develop blood clots in the splenic, portal, or superior mesenteric veins and whether those clots are linked to more severe illness.

  Recruiting Asian Institute of Gastroenterology, India · Hyderabad, Telangana · NCT07322978

• Fecal microbiota transplant for people with moderate to severe acute pancreatitis

  This trial will test whether a fecal microbiota transplant (FMT) can reduce late complications in adults with moderate to severe acute pancreatitis.

  Recruiting at 2 sites Changhai Hospital · Shanghai, Shanghai Municipality and 1 other locations · NCT07153809

• Blood markers to detect infected pancreatic necrosis

  We will test whether specific blood markers can help predict or diagnose infected pancreatic necrosis in adults with necrotizing pancreatitis.

  Recruiting University of Minnesota · Minneapolis, Minnesota · NCT06899087

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.