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(352) 733-0111

DREAM

  • Status
    Accepting Candidates
  • Age
    18 Years - 75 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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).

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.

Details

Full study title Diabetes RElated to Acute pancreatitis and its Mechanisms (DREAM)
Protocol number OCR41546
ClinicalTrials.gov ID NCT05197920

Eligibility

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

Lead researcher

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  1. Step
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    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

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