An Observational Study on Post-chronic Pancreatitis Diabetes Mellitus

May 25, 2023 updated by: Zhuan Liao, Changhai Hospital

An Observational Study of Risk Factors Influencing Glycemic Status and Optimized Treatment on Post-chronic Pancreatitis Diabetes Mellitus

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

324

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Shanghai Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

February 29, 2024

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

February 18, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPDM-C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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