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).
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.
Study Type
OBSERVATIONAL
Enrollment
800
University of Southern California
Los Angeles, California, United States
RECRUITINGCedars-Sinai Medical Center
Los Angeles, California, United States
diabetes mellitus (DM) following a qualifying episode of acute pancreatitis (AP)
time to onset of DM during the 36-month longitudinal follow-up period
Time frame: any time during the 36-month longitudinal follow-up period
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
Time frame: months 3, 12, 24, and 36
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)
Time frame: months 3, 12, 24, and 36
PROMIS-29 Physical Function
PROMIS-29 Physical Function, converted to a t-score with a mean of 50 and a standard deviation of 10
Time frame: months 3, 12, 24, and 36
PROMIS-29 Anxiety
PROMIS-29 Anxiety, converted to a t-score with a mean of 50 and a standard deviation of 10
Time frame: months 3, 12, 24, and 36
PROMIS-29 Depression
PROMIS-29 Depression, converted to a t-score with a mean of 50 and a standard deviation of 10
Time frame: months 3, 12, 24, and 36
PROMIS-29 Fatigue
PROMIS-29 Fatigue, converted to a t-score with a mean of 50 and a standard deviation of 10
Time frame: months 3, 12, 24, and 36
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Stanford University
Stanford, California, United States
RECRUITINGUniversity of Florida
Gainesville, Florida, United States
RECRUITINGAdventHealth
Orlando, Florida, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGUniversity of Illinois at Chicago
Chicago, Illinois, United States
RECRUITINGIndiana University
Indianapolis, Indiana, United States
RECRUITINGJohns Hopkins University
Baltimore, Maryland, United States
RECRUITINGUniversity of Minnesota
Minneapolis, Minnesota, United States
RECRUITING...and 3 more locations
PROMIS-29 Sleep Disturbance
PROMIS-29 Sleep Disturbance, converted to a t-score with a mean of 50 and a standard deviation of 10
Time frame: months 3, 12, 24, and 36
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
Time frame: months 3, 12, 24, and 36
PROMIS-29 Pain Interference
PROMIS-29 Pain Interference, converted to a t-score with a mean of 50 and a standard deviation of 10
Time frame: months 3, 12, 24, and 36
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
Time frame: months 3, 12, 24, and 36
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
Time frame: months 3, 12, 24, and 36
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)
Time frame: months 3, 12, 24, and 36
MMTT Glucagon
Mixed Meal Tolerance Testing (MMTT) Glucagon (pg/mL)
Time frame: months 3, 12, 24, and 36
MMTT Pancreatic Polypeptide (PP)
Mixed Meal Tolerance Testing (MMTT) Pancreatic Polypeptide (PP, pg/mL)
Time frame: months 3, 12, 24, and 36
FSIGTT Acute Insulin Response to Glucose (AIRglu)
Frequently Sampled Intravenous Glucose Tolerance Testing (FSIGTT) Acute Insulin Response to Glucose (AIRglu)
Time frame: months 3 and 12
FSIGTT Acute C-peptide Response to Glucose (ACRglu)
Frequently Sampled Intravenous Glucose Tolerance Testing (FSIGTT) Acute C-peptide Response to Glucose (ACRglu)
Time frame: months 3 and 12
FSIGTT Total Body Insulin Sensitivity Index (SI)
Frequently Sampled Intravenous Glucose Tolerance Testing (FSIGTT) Total Body Insulin Sensitivity Index (SI)
Time frame: months 3 and 12
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
Time frame: months 3 and 12
Islet Autoantibodies
Islet Autoantibodies
Time frame: months 3, 12, 24, and 36
Fecal Elastase
Fecal Elastase (ug/g)
Time frame: months 3, 12, 24, and 36