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

Naval Military Medical University (Second Military Medical University)

Status and phase: Enrolling; Early Phase 1

Conditions: Chronic Pancreatitis Pancreatic Exocrine Insufficiency Blood Glucose

Treatments: Drug: Creon（Pancreatin Enteric-coated Capsules）

Study type: Interventional

Funder types: Other

Identifiers

NCT07314489

2025SL054

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Creon（Pancreatin Enteric-coated Capsules）

Active Comparator group

Description:

For newly diagnosed patients with chronic pancreatitis combined with exocrine insufficiency, administer the Creon capsules and take them regularly for 3 months.

Treatment:

Drug: Creon（Pancreatin Enteric-coated Capsules）