NCT05197920

Diabetes RElated to Acute Pancreatitis and Its Mechanisms

Diabetes RElated to Acute Pancreatitis and Its Mechanisms (DREAM) An Observational Cohort Study From the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Acute Pancreatitis

Timeline

• Start date: 2022-01-14
• Primary completion: 2030-01-31
• Completion: 2030-01-31
• First posted: 2022-01-20
• Last updated: 2025-11-18

Locations

13 sites across 1 country: United States