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Acute PancreatitisDREAMNCT05197920

Diabetes RElated to Acute Pancreatitis and Its Mechanisms

An observational study of Acute Pancreatitis, run by Milton S. Hershey Medical Center at 13 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Pancreatitis
How many people
800 participants
Where
13 sitesUnited States
Study dates
14 Jan 2022to 31 Jan 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients hospitalized for acute pancreatitis

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Melissa A Butt, DrPH contact

717-531-1258

mbutt1@pennstatehealth.psu.edu

Kendall T Baab, BS contact

717-531-6308

kthomas4@pennstatehealth.psu.edu

13 sites in 1 country

United States13 sites, 13 recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21205

    Mahya Faghih, 443-287-4680, mfaghih2@jhu.edu

    Vikesh Singh, MD, MSc

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Christine Nelson, 312-695-4513, c-ebert@northwestern.edu

    Rajesh N Keswani, MD, MS

    Recruiting

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

    Haya Al Rashdan, 312-413-0306, halras2@uic.edu

    Cemal Yazici, MD, MSc

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Zoe Krebs, 614-685-6374, Zoe.krebs@osumc.edu

    Phillip A Hart, MD

    Recruiting

  • University of Florida

    Gainesville, Florida, 32610-0214

    Amber Bouton, 352-273-9774, amber.bouton@surgery.ufl.edu

    Chris Forsmark, MD

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Maureen Mullen-Montagano, 317-274-7677, maamulle@iu.edu

    Evan L Fogel, MD

    Recruiting

  • University of Southern California

    Los Angeles, California, 90033

    Jessica Serna, 323-409-6939, sernaj@usc.edu

    James L Buxbaum, MD

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Eleanor Chang, 310-423-0747, eleanor.chang@cshs.org

    Mark O Goodarzi, MD, PhD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55454

    Heather Hodgkins, 612-626-5293, Hodg0007@umn.edu

    Melena D Bellin, MD

    Recruiting

  • AdventHealth

    Orlando, Florida, 32804

    Gina Mercouffer, 407-303-7106, Gina.Mercouffer@adventHealth.com

    Richard E Pratley, MD

    Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

    Shari Reynolds, 412-383-0570, Reynoldss12@upmc.edu

    Dhiraj Yadav, MD, MPH

    Recruiting

  • Benaroya Research Institute

    Seattle, Washington, 98101

    Kim Varner, 206-341-8936, kvarner@benaroyaresearch.org

    Carla J Greenbaum, MD

    Recruiting

  • Stanford University

    Stanford, California, 94305

    Lorena Pineda, 650-723-4519, ljpineda@stanford.edu

    Walter Park, MD

    Recruiting

Other trials in United States

About this study

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)

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).

Read the detailed description

The DREAM investigators will conduct dynamic metabolic testing that includes oral glucose tolerance testing (OGTT), mixed meal tolerance testing (MMTT), and frequently sampled intravenous glucose tolerance testing (FSIGTT). These tests will increase the sensitivity for DM diagnosis (with OGTT) and to assess beta cell function and other pancreatic and enteroendocrine hormones involved in maintaining glucose homeostasis (OGTT, MMTT and FSIGTT). The DREAM research hypotheses are as follows.

  1. There is a cumulative increase in the risk of any type of DM after an episode of AP, and the development of DM after AP is influenced by several patient and disease-related factors (e.g. age, etiology, disease severity).
  2. After AP is clinically resolved, there is ongoing subclinical beta cell damage that predisposes to delayed-onset of DM.
  3. AP triggers an altered immune state in a subset of individuals that predisposes to islet autoimmunity and DM.
Keywords
Diabetes
Medical subject headings
Pancreatitis, Diabetes Mellitus

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: any time during the 36-month longitudinal follow-up period

Secondary outcomes (20)

  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

    Measured: months 3, 12, 24, and 36

  2. 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)

    Measured: months 3, 12, 24, and 36

  3. PROMIS-29 Physical Function

    PROMIS-29 Physical Function, converted to a t-score with a mean of 50 and a standard deviation of 10

    Measured: months 3, 12, 24, and 36

  4. PROMIS-29 Anxiety

    PROMIS-29 Anxiety, converted to a t-score with a mean of 50 and a standard deviation of 10

    Measured: months 3, 12, 24, and 36

  5. PROMIS-29 Depression

    PROMIS-29 Depression, converted to a t-score with a mean of 50 and a standard deviation of 10

    Measured: months 3, 12, 24, and 36

  6. PROMIS-29 Fatigue

    PROMIS-29 Fatigue, converted to a t-score with a mean of 50 and a standard deviation of 10

    Measured: months 3, 12, 24, and 36

  7. PROMIS-29 Sleep Disturbance

    PROMIS-29 Sleep Disturbance, converted to a t-score with a mean of 50 and a standard deviation of 10

    Measured: months 3, 12, 24, and 36

  8. PROMIS-29 Ability to Participate in Social Roles and Activities

    PROMIS-29 Ability to Participate in Social Roles and Activities, converted to a t-score with a mean of 50 and a standard deviation of 10

    Measured: months 3, 12, 24, and 36

  9. PROMIS-29 Pain Interference

    PROMIS-29 Pain Interference, converted to a t-score with a mean of 50 and a standard deviation of 10

    Measured: months 3, 12, 24, and 36

  10. OGTT Insulin Secretion

    Oral Glucose Tolerance Testing (OGTT) Insulin Secretion, as measured by the insulin area under the curve relative to the glucose area under the curve

    Measured: months 3, 12, 24, and 36

  11. OGTT Insulin Sensitivity Index

    Oral Glucose Tolerance Testing (OGTT) Insulin Sensitivity Index, as measured by the glucose disposal rate divided by the average plasma insulin concentration

    Measured: months 3, 12, 24, and 36

  12. MMTT Incretin Hormones: GIP and GLP-1

    Mixed Meal Tolerance Testing (MMTT) Incretin Hormones: Glucose-dependent Insulinotropic Polypeptide (GIP, pmol/L) and Glucagon-like Peptide-1 (GLP-1, pmol/L)

    Measured: months 3, 12, 24, and 36

  13. MMTT Glucagon

    Mixed Meal Tolerance Testing (MMTT) Glucagon (pg/mL)

    Measured: months 3, 12, 24, and 36

  14. MMTT Pancreatic Polypeptide (PP)

    Mixed Meal Tolerance Testing (MMTT) Pancreatic Polypeptide (PP, pg/mL)

    Measured: months 3, 12, 24, and 36

  15. FSIGTT Acute Insulin Response to Glucose (AIRglu)

    Frequently Sampled Intravenous Glucose Tolerance Testing (FSIGTT) Acute Insulin Response to Glucose (AIRglu)

    Measured: months 3 and 12

  16. FSIGTT Acute C-peptide Response to Glucose (ACRglu)

    Frequently Sampled Intravenous Glucose Tolerance Testing (FSIGTT) Acute C-peptide Response to Glucose (ACRglu)

    Measured: months 3 and 12

  17. FSIGTT Total Body Insulin Sensitivity Index (SI)

    Frequently Sampled Intravenous Glucose Tolerance Testing (FSIGTT) Total Body Insulin Sensitivity Index (SI)

    Measured: months 3 and 12

  18. FSIGTT Total Body Insulin Sensitivity Index (SI) Disposition Index

    Frequently Sampled Intravenous Glucose Tolerance Testing (FSIGTT) Disposition Index (DI), calculated as the product of the AIRglu and the Total Body Insulin SI

    Measured: months 3 and 12

  19. Islet Autoantibodies

    Islet Autoantibodies

    Measured: months 3, 12, 24, and 36

  20. Fecal Elastase

    Fecal Elastase (ug/g)

    Measured: months 3, 12, 24, and 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2022
  2. Study start14 Jan 2022
  3. Primary completion31 Jan 2030 (estimated)
  4. Study completion31 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05197920
Sponsor's protocol ID
Penn State College of Medicine
Other IDs
U01DK127384
Acronym
DREAM
Status last verified
Nov 2025
First submitted
11 Dec 2021
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data from final locked datasets will be made available to other researchers outside the DREAM investigative team. The plan for data sharing incorporates a strategy that recognizes the importance of protecting participants' rights to individual privacy and is compliant with HIPAA regulations and NIH requirements (https://grants.nih.gov/grants/policy/data\_sharing/).

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Pancreatitis, run by Milton S. Hershey Medical Center at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Melissa A Butt, DrPH (717-531-1258, mbutt1@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

diabetes mellitus (DM) following a qualifying episode of acute pancreatitis (AP) (time frame: any time during the 36-month longitudinal follow-up period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05197920.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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