Actively Recruiting

Age: 18Years - 75Years
All Genders
ID05197920

Diabetes RElated to Acute Pancreatitis and Its Mechanisms (DREAM) Observational Cohort Study From the Type 1 Diabetes in Acute Pancreatitis Consortium

Led by Milton S. Hershey Medical Center ยท Updated on 2025-11-18

800

Participants Needed

13

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Milton S. Hershey Medical Center

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how diabetes develops after an episode of acute pancreatitis (AP) through a 36-month observational study called DREAM. The study aims to understand the frequency, causes, and biological changes involved in diabetes following AP, including the possible ongoing damage to insulin-producing cells and immune system changes that may increase diabetes risk. Participants undergo several metabolic tests such as oral glucose tolerance testing, mixed meal tolerance testing, and frequently sampled intravenous glucose tolerance testing to detect diabetes early and assess pancreatic function. These tests, performed at multiple time points, help study hormone responses and insulin secretion related to diabetes development after AP. During the study, participants will be followed for three years with regular assessments including metabolic tests and questionnaires about health, pain, physical function, anxiety, depression, fatigue, sleep, social participation, and immune markers. Researchers will monitor the onset of diabetes, pancreatic function, and autoimmune changes to better understand diabetes linked to acute pancreatitis.

CONDITIONS

Brief Title

Diabetes RElated to Acute Pancreatitis and Its Mechanisms

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of acute pancreatitis within 0 to 90 days before enrollment
  • Ability to fully participate in the study including informed consent, completing forms, interviews, metabolic tests, and follow-ups
  • Age between 18 and 75 years
Not Eligible

You will not qualify if you...

  • Definite chronic pancreatitis diagnosed by imaging before enrollment
  • Post-endoscopic retrograde cholangiopancreatography acute pancreatitis with hospitalization less than 48 hours
  • Prior pancreatic necrosectomy or drainage before enrollment
  • Pancreatic tumors or cystic tumors causing acute pancreatitis
  • Prior pancreatic surgery such as distal pancreatectomy or pancreaticoduodenectomy
  • Use of disallowed medications within 30 days before enrollment
  • Severe systemic illnesses like organ transplant, AIDS, recent cancer treatment, advanced kidney disease, or cirrhosis
  • Known pregnancy at enrollment
  • Incarceration
  • Any condition that would risk safety or affect study integrity

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 3 months

Participants undergo dynamic metabolic testing including oral glucose tolerance testing (OGTT), mixed meal tolerance testing (MMTT), and frequently sampled intravenous glucose tolerance testing (FSIGTT) to assess diabetes diagnosis and pancreatic function.

Visits at months 3, 12, 24, and 36 with additional FSIGTT testing at months 3 and 12

Long-term Monitoring

Duration - 36 months

Participants are followed over 36 months to monitor the development of diabetes and related metabolic changes after acute pancreatitis.

Follow-up visits at months 3, 12, 24, and 36 for assessments including PROMIS health questionnaires, islet autoantibodies, and fecal elastase

Trial Site Locations

Total: 13 locations

1

University of Southern California

Los Angeles, California, United States, 90033

Actively Recruiting

2

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

3

Stanford University

Stanford, California, United States, 94305

Actively Recruiting

4

University of Florida

Gainesville, Florida, United States, 32610-0214

Actively Recruiting

5

AdventHealth

Orlando, Florida, United States, 32804

Actively Recruiting

6

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

7

University of Illinois at Chicago

Chicago, Illinois, United States, 60612

Actively Recruiting

8

Indiana University

Indianapolis, Indiana, United States, 46202

Actively Recruiting

9

Johns Hopkins University

Baltimore, Maryland, United States, 21205

Actively Recruiting

10

University of Minnesota

Minneapolis, Minnesota, United States, 55454

Actively Recruiting

11

Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

12

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

13

Benaroya Research Institute

Seattle, Washington, United States, 98101

Actively Recruiting

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Research Team

M

Melissa A Butt, DrPH

K

Kendall T Baab, BS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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