Diabetes RElated to Acute Pancreatitis and Its Mechanisms

Acute Pancreatitis Clinical Trial

— DREAM  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05197920
• Other study ID #: Penn State College of Medicine
• Secondary ID: U01DK127384
• Status: Recruiting
• Start date: January 14, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: Milton S. Hershey Medical Center
• Contact: Melissa A Butt, DrPH
• Phone: 717-531-1258
• Email: mbutt1[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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 <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

• 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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Northwestern University	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	University of Florida	Gainesville	Florida
United States	Indiana University	Indianapolis	Indiana
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	AdventHealth	Orlando	Florida
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Benaroya Research Institute	Seattle	Washington
United States	Stanford University	Stanford	California

Sponsors (15)

Lead Sponsor

Collaborator

Milton S. Hershey Medical Center

AdventHealth, Benaroya Research Institute, Cedars-Sinai Medical Center, Indiana University, Johns Hopkins University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwestern University, Ohio State University, Stanford University, University of Florida, University of Illinois at Chicago, University of Minnesota, University of Pittsburgh, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diabetes mellitus (DM) following a qualifying episode of acute pancreatitis (AP)	time to onset of DM during the 36-month longitudinal follow-up period	any time during the 36-month longitudinal follow-up period
Secondary	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	months 3, 12, 24, and 36
Secondary	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)	months 3, 12, 24, and 36
Secondary	PROMIS-29 Physical Function	PROMIS-29 Physical Function, converted to a t-score with a mean of 50 and a standard deviation of 10	months 3, 12, 24, and 36
Secondary	PROMIS-29 Anxiety	PROMIS-29 Anxiety, converted to a t-score with a mean of 50 and a standard deviation of 10	months 3, 12, 24, and 36
Secondary	PROMIS-29 Depression	PROMIS-29 Depression, converted to a t-score with a mean of 50 and a standard deviation of 10	months 3, 12, 24, and 36
Secondary	PROMIS-29 Fatigue	PROMIS-29 Fatigue, converted to a t-score with a mean of 50 and a standard deviation of 10	months 3, 12, 24, and 36
Secondary	PROMIS-29 Sleep Disturbance	PROMIS-29 Sleep Disturbance, converted to a t-score with a mean of 50 and a standard deviation of 10	months 3, 12, 24, and 36
Secondary	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	months 3, 12, 24, and 36
Secondary	PROMIS-29 Pain Interference	PROMIS-29 Pain Interference, converted to a t-score with a mean of 50 and a standard deviation of 10	months 3, 12, 24, and 36
Secondary	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	months 3, 12, 24, and 36
Secondary	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	months 3, 12, 24, and 36
Secondary	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)	months 3, 12, 24, and 36
Secondary	MMTT Glucagon	Mixed Meal Tolerance Testing (MMTT) Glucagon (pg/mL)	months 3, 12, 24, and 36
Secondary	MMTT Pancreatic Polypeptide (PP)	Mixed Meal Tolerance Testing (MMTT) Pancreatic Polypeptide (PP, pg/mL)	months 3, 12, 24, and 36
Secondary	FSIGTT Acute Insulin Response to Glucose (AIRglu)	Frequently Sampled Intravenous Glucose Tolerance Testing (FSIGTT) Acute Insulin Response to Glucose (AIRglu)	months 3 and 12
Secondary	FSIGTT Acute C-peptide Response to Glucose (ACRglu)	Frequently Sampled Intravenous Glucose Tolerance Testing (FSIGTT) Acute C-peptide Response to Glucose (ACRglu)	months 3 and 12
Secondary	FSIGTT Total Body Insulin Sensitivity Index (SI)	Frequently Sampled Intravenous Glucose Tolerance Testing (FSIGTT) Total Body Insulin Sensitivity Index (SI)	months 3 and 12
Secondary	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	months 3 and 12
Secondary	Islet Autoantibodies	Islet Autoantibodies	months 3, 12, 24, and 36
Secondary	Fecal Elastase	Fecal Elastase (ug/g)	months 3, 12, 24, and 36

External Links

•   Public web site for the Type 1 Diabetes in Acute Pancreatitis Consortium