A Study on the Changes of Glucose Metabolism and Exocrine Function in Patients With Chronic Pancreatitis

December 17, 2025 updated by: Tuo Li, MD, Shanghai Changzheng Hospital

A Prospective Cohort Study on the Changes of Glucose Metabolism and Exocrine Function in Patients With Chronic Pancreatitis Complicated With Exocrine Dysfunction After Pancreatic Enzyme Intervention

This study aims to investigate the impact of pancreatic exocrine insufficiency on the glucose profile and pancreatic and gastrointestinal endocrine hormones in patients with chronic pancreatitis through pancreatic enzyme intervention in a reverse manner.

The primary objective is to observe the changes in glucose profile following pancreatic enzyme intervention in patients with chronic pancreatitis complicated by exocrine insufficiency and normal glucose metabolism.

The secondary objective is to observe the changes in pancreatic endocrine and exocrine functions and gastrointestinal endocrine hormone levels following pancreatic enzyme intervention in patients with chronic pancreatitis complicated by exocrine insufficiency and normal glucose metabolism.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Early Phase 1

Contacts and Locations

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

Study Contact

Study Locations

  • China
      • Shanghai, China, 200003
        • Not yet recruiting
        • Changzheng hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200003
        • Recruiting
        • Shanghai Changzheng Hospital
        • Contact:
        • Contact:

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

Description

Inclusion Criteria:

  • 1. Male or female Chinese subjects aged 18 years or older; 2. Patients with a clear diagnosis of chronic pancreatitis; 3. Glycated hemoglobin (HbA1c) levels between 4% and 6%; 4. FE-1 < 100 µg/g.

Exclusion Criteria:

  • 1. A history of diabetes or prediabetes, or preoperative glycated hemoglobin (HbA1c) ≥ 6.0% or fasting venous glucose ≥ 6.1 mmol/L; 2. Positive for islet-related antibodies; 3. Patients who are currently receiving or have previously received pancreatic enzyme replacement therapy (PERT); 4. Allergy to the components of PERT drugs; 5. Exocrine pancreatic insufficiency (EPI) caused by other reasons, such as post-gastrectomy or post-intestinal resection; 6. Undergoing pancreatic surgery other than endoscopic retrograde cholangiopancreatography (ERCP); 7. Renal disease of stage G3, G4, or G5; 8. Decompensated chronic liver disease; 9. Receiving glucocorticoid therapy; 10. Pregnant or breastfeeding women; 11. Patients with malignant tumors.

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

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Creon（Pancreatin Enteric-coated Capsules）
For newly diagnosed patients with chronic pancreatitis combined with exocrine insufficiency, administer the Creon capsules and take them regularly for 3 months.
Drug: Creon（Pancreatin Enteric-coated Capsules）
This product is a mixture of various enzymes extracted from pig pancreas, mainly including trypsin, pancreatic lipase and pancreatic amylase.Take 1 tablet (0.3g) during meals, 3 times a day.0.3 grams is equivalent to 20,000 European Pharmacopoeia units of pancreatic lipase, 16,000 European Pharmacopoeia units of pancreatic amylase, and 1,200 European Pharmacopoeia units of pancreatic protease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The changes in glucose profile before and after pancreatic enzyme intervention
Time Frame: From enrollment to 3 months after pancreatic enzyme intervention
From enrollment to 3 months after pancreatic enzyme intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure the changes in pancreatic endocrine and exocrine functions and gastrointestinal endocrine hormone levels after pancreatic enzyme intervention.
Time Frame: From enrollment to 3 months after pancreatic enzyme intervention
From enrollment to 3 months after pancreatic enzyme intervention

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 (Actual)

April 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2035

Study Registration Dates

First Submitted

July 4, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Estimated)

January 2, 2026

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025SL054

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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