Diabetes RElated to Acute Pancreatitis and Its Mechanisms

Официальное название

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

Обзор

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).

Подробное описание

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.

Первичные конечные точки

• diabetes mellitus (DM) following a qualifying episode of acute pancreatitis (AP) [Срок оценки: any time during the 36-month longitudinal follow-up period]

Вторичные конечные точки (12)

• PROMIS Global Health [Срок оценки: months 3, 12, 24, and 36]
• PROMIS Pain Intensity [Срок оценки: months 3, 12, 24, and 36]
• PROMIS-29 Physical Function [Срок оценки: months 3, 12, 24, and 36]
• PROMIS-29 Anxiety [Срок оценки: months 3, 12, 24, and 36]
• PROMIS-29 Depression [Срок оценки: months 3, 12, 24, and 36]
• PROMIS-29 Fatigue [Срок оценки: months 3, 12, 24, and 36]
• PROMIS-29 Sleep Disturbance [Срок оценки: months 3, 12, 24, and 36]
• PROMIS-29 Ability to Participate in Social Roles and Activities [Срок оценки: months 3, 12, 24, and 36]
• PROMIS-29 Pain Interference [Срок оценки: months 3, 12, 24, and 36]
• OGTT Insulin Secretion [Срок оценки: months 3, 12, 24, and 36]
• OGTT Insulin Sensitivity Index [Срок оценки: months 3, 12, 24, and 36]
• MMTT Incretin Hormones: GIP and GLP-1 [Срок оценки: months 3, 12, 24, and 36]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 13 центров

• University of Southern California — Los Angeles
• Cedars-Sinai Medical Center — Los Angeles
• Stanford University — Stanford
• University of Florida — Gainesville
• AdventHealth — Orlando
• Northwestern University — Chicago
• University of Illinois at Chicago — Chicago
• Indiana University — Indianapolis
• … и ещё 5 центров

Идентификаторы

NCT: NCT05197920 · Penn State College of Medicine · U01DK127384

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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