Endocrine and Exocrine Secretory Function Alterations Aft... | NCT06590935

Studies
Endocrine and Exocrine Secretory Function Alterations After Moderately Severe and Severe Acute Pancreatitis

NCT06590935

Sponsor

Shanghai Changzheng Hospital

Status

Active, not recruiting

Last Update Posted

Feb 21, 2025Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Acute Pancreatitis (AP)
Diabetes Mellitus

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 8, 2024Actual

Primary Completion Date

Sep 2026Estimated

Completion Date

Sep 2026Estimated

First Submitted Date

Aug 29, 2024

First Submission Date that Met QC Criteria

Sep 6, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2025

Last Update Posted Date

Feb 21, 2025Actual

Name	Class
Changhai Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to learn about post-acute pancreatitis diabetes mellitus (PPDM-A). The main questions it aims to answer are:

Are the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after acute pancreatitis of different etiologies the same?
Are alterations in endocrine and exocrine secretory function in patients with acute pancreatitis associated with all-round outcomes?

All patients with acute pancreatitis have been given the standardized treatment for the condition.

Investigators will compare the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after acute pancreatitis of different etiologies in patients with moderately severe (MSAP) and severe acute pancreatitis (SAP) to explore the association between alterations in endocrine and exocrine secretory function and all-round outcomes.

Detailed Description

Investigators will prospectively collect data from patients with moderately severe (MSAP) and severe acute pancreatitis (SAP) in participant centers.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

52 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Estimated

Label	Type	Description	Intervention Names
Acute pancreatitis		Patients with a complete diagnosis of MSAP and SAP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Who developed glucose metabolic disorders (pre-diabetes and diabetes mellitus)	The diagnosis of glucose metabolic disorders should be made applying the criteria of the American Diabetes Association.	From the AP treatment to 5 years after the end of treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female Chinese subjects;
Age ≥18 years at the time of signing the informed consent;
Patients with a complete diagnosis of MSAP and SAP (according to the Chinese guidelines for the diagnosis and treatment of acute pancreatitis 2019);
Voluntary signatories of informed consent

Exclusion Criteria:

Patients with a history of diabetes mellitus or pre-diabetes mellitus, or glycosylated hemoglobin ≥ 6.0% or venous FPG ≥ 6.1 mmol/L at admission;
Patients have any evidence of type 1 diabetes-related autoimmunity;
Patients have any risk for secondary diabetes due to exposure to medications or other endocrine diseases;
Combined with pancreas-related trauma or a history of pancreatic surgery;
Patients undergo pancreatic surgery during treatment;
Pregnancy or breastfeeding;
Patients suffer from severe cardiac, hepatic or renal insufficiency or malignant diseases;
Failure to sign informed consent due to cognitive impairment or other conditions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Investigators will collect data from patients with moderately severe (MSAP) and severe acute pancreatitis (SAP) in participant centers.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Tuo Li, Prof.	Shanghai Changzheng Hospital	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Changzheng Hospital		Shanghai	Shanghai Municipality	20003	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35188346	Background	Bharmal SH, Cho J, Ko J, Petrov MS. Glucose variability during the early course of acute pancreatitis predicts two-year probability of new-onset diabetes: A prospective longitudinal cohort study. United European Gastroenterol J. 2022 Mar;10(2):179-189. doi: 10.1002/ueg2.12190. Epub 2022 Feb 20.
32494905	Background

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

ID	Term
D010195	Pancreatitis
D003920	Diabetes Mellitus