The Characteristics of Blood Glucose Profile and the Changes of Hormones in PPDM-C Population

February 10, 2025 updated by: Tuo Li, MD, Shanghai Changzheng Hospital

The Characteristics of Blood Glucose Profile and the Changes of Endogenous and Exogenous Hormones in Patients with Post-chronic Pancreatitis Diabetes Mellitus

The purpose of this study was to explore the characteristics of blood glucose spectrum, changes of endocrine/exocrine pancreatic function and the correlation between them in patients with PPDM-C.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The benefits of this study to participants include:

  1. It will help to make early diagnosis or risk screening for the potential related risks and concomitant diseases of the disease;
  2. Provide necessary suggestions for the treatment and intervention of the disease, or provide useful information for the related research of the disease.
  3. We will provide Abbott version h dynamic glucose meter and assessment of internal and external secretion function. The researcher will provide professional endocrine related lifestyle and drug guidance for the subjects according to their CGMS data.

The risks that this study may bring to participants are:

There may be some very small risks in specimen collection, including transient pain, local cyanosis, etc. a few people will have mild dizziness or extremely rare needle infection.

Study Type

Observational

Enrollment (Estimated)

2000

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

patients with chronic pancreatitis

Description

Inclusion Criteria:

  • Male or female Chinese subjects;

    • Was ≥ 18 years old when signing the informed consent;

      • Patients with complete diagnosis of chronic pancreatitis; ④ Those who voluntarily signed informed consent; ⑤ Those who complete serum samples in multiple centers and put them into storage.

Exclusion Criteria:

  • Patients with impaired glucose tolerance but undiagnosed diabetes;

    • Patients with T1DM related autoimmune markers or other types of DM;

      • Patients with autoimmune pancreatitis, recurrent acute pancreatitis or acute onset of chronic pancreatitis;

        • Patients who underwent pancreatic surgery or related invasive procedures during treatment;

          • Previous or current malignant tumor; ⑥ Pregnancy or lactation; ⑦ Suffering from severe heart, liver or kidney dysfunction or malignant disease; ⑧ Failure to sign informed consent for cognitive impairment or other reasons.

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
Time Frame
Blood glucose profile characteristics of patients with PPDM-C
Time Frame: From February 2025 to December 2025
From February 2025 to December 2025

Collaborators and Investigators

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

Sponsor

Shanghai Changzheng 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 (Estimated)

February 11, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024SL140

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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