An Observational Study on Post-chronic Pancreatitis Diabe... | NCT05764629

Studies
An Observational Study on Post-chronic Pancreatitis Diabetes Mellitus

NCT05764629

Sponsor

Changhai Hospital

Status

Active, not recruiting

Last Update Posted

May 26, 2023Actual

Enrollment

324Actual

Phase

Not provided

Conditions

Chronic Pancreatitis
Diabetes Mellitus

Interventions

blood test
pharmacologic approaches to glycemic treatment

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

Mar 2023

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

Sep 1, 2021Actual

Primary Completion Date

Feb 29, 2024Estimated

Completion Date

Dec 31, 2030Estimated

First Submitted Date

Feb 18, 2023

First Submission Date that Met QC Criteria

Mar 9, 2023

First Posted Date

Mar 10, 2023Actual

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

May 25, 2023

Last Update Posted Date

May 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

To explore the risk factors influencing glycemic status, optimized treatment, and prognosis of post-chronic pancreatitis diabetes mellitus (PPDM-C).

Detailed Description

The present study was an observational study aimed to explore risk factors influencing glycemic status, optimized treatment, and prognosis of post-chronic pancreatitis diabetes mellitus. The observation items included clinical characteristics, blood glucose control and incidence of complications of PPDM-C.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

324Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood test	Diagnostic Test	Testing the peripheral blood for PPDM-C, including blood glucose, glycated hemoglobin A1c, fasting insulin and C-peptide, etc.
pharmacologic approaches to glycemic treatment	Drug	documenting the change of glycemic treatment during the follow-up period

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemoglobin A1c (HbA1c)	measure the control of blood glucose of every 3 months	through study completion, an average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
Adverse events	Incidence and frequency (number of events) of adverse events (%) such as hypoglycemia, cardiovascular disease, etc.	through study completion, an average of 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with diagnosis of chronic pancreatitis and diabetes mellitus.
participants with painless chronic pancreatitis were diagnosed with diabetes within 2 years of the diagnosis of chronic pancreatitis.
participants with painful chronic pancreatitis were diagnosed with diabetes after the first attack of chronic pancreatitis.

Exclusion Criteria:

participants with suspected malignant tumors of the pancreas or other sites of body, or participants in the terminal stage of severe disease
serious mental illness, lesion of liver or kidney, pregnancy, breast-feeding or planning pregnancy
definitely diagnosed type 1 diabetes, type 2 diabetes, or other metabolic diseases that affect blood glucose
autoimmune pancreatitis
Scarcity of information related to HbA1c
death or loss of follow-up during follow-up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Consequent patients with a diagnosis of PPDM-C in Changhai Hospital between 2018 to 2022

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050500	Pancreatitis, Chronic
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D010195	Pancreatitis
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided