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

NCT07314489 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 2025SL054
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Pancreatitis Pancreatic Exocrine Insufficiency Blood Glucose

Keywords

chronic pancreatitis; pancreatitis; exocrine insufficiency; blood glucose

Outcome Measures

Primary Outcomes (1)

• The changes in glucose profile before and after pancreatic enzyme intervention

  From enrollment to 3 months after pancreatic enzyme intervention

Secondary Outcomes (1)

• Measure the changes in pancreatic endocrine and exocrine functions and gastrointestinal endocrine hormone levels after pancreatic enzyme intervention.

  From enrollment to 3 months after pancreatic enzyme intervention

Study Arms (1)

Creon（Pancreatin Enteric-coated Capsules）

ACTIVE COMPARATOR

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）

Interventions

Creon（Pancreatin Enteric-coated Capsules） DRUG

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.

Creon（Pancreatin Enteric-coated Capsules）

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (2)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

Changzheng Hospital

Shanghai, 200003, China

NOT YET RECRUITING

MeSH Terms

Conditions

Pancreatitis, Chronic; Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tuo Li, Doctor

CONTACT

86-13918507887; dr.lituo@smmu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: January 2, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2035
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

CN (2)