Diabetes RElated to Acute Pancreatitis and Its Mechanisms: Metabolic Outcomes Using Novel CGM Metrics
NCT06401577
Acute Pancreatitis, Diabetes Mellitus
Los Angeles, California, United States
View Trial DetailsNCT Number: NCT05197920
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).
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Cedars-Sinai Medical Center, Los Angeles, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: any time during the 36-month longitudinal follow-up period
time to onset of DM during the 36-month longitudinal follow-up period
Time frame: months 3, 12, 24, and 36
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
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, 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, 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, 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, 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 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, 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, converted to a t-score with a mean of 50 and a standard deviation of 10
Time frame: months 3, 12, 24, and 36
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
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
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
Mixed Meal Tolerance Testing (MMTT) Glucagon (pg/mL)
Time frame: months 3, 12, 24, and 36
Mixed Meal Tolerance Testing (MMTT) Pancreatic Polypeptide (PP, pg/mL)
Time frame: months 3 and 12
Frequently Sampled Intravenous Glucose Tolerance Testing (FSIGTT) Acute Insulin Response to Glucose (AIRglu)
Time frame: months 3 and 12
Frequently Sampled Intravenous Glucose Tolerance Testing (FSIGTT) Acute C-peptide Response to Glucose (ACRglu)
Time frame: months 3 and 12
Frequently Sampled Intravenous Glucose Tolerance Testing (FSIGTT) Total Body Insulin Sensitivity Index (SI)
Time frame: months 3 and 12
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, 12, 24, and 36
Islet Autoantibodies
Time frame: months 3, 12, 24, and 36
Fecal Elastase (ug/g)
Contact information is provided by the study sponsor or research team.
Kendall T Baab, BS
CONTACT
Melissa A Butt, DrPH
CONTACT
Milton S. Hershey Medical Center
Other
Diabetes RElated to Acute Pancreatitis and Its Mechanisms (DREAM) An Observational Cohort Study From the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC)
Acronym: DREAM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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