Pancreatic enzyme treatment for blood sugar and digestion changes in chronic pancreatitis
Official title: 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
Run by Shanghai Changzheng Hospital · NCT07314489 · Data updated 2026-11-12
This trial will try pancreatic enzyme capsules (Creon) in adults with chronic pancreatitis and exocrine insufficiency to see if their blood sugar patterns and digestive and gut hormone levels change.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Shanghai Changzheng Hospital Academic / other |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2035 |
| Registry record updated | January 2, 2026 |
| Trial ID | NCT07314489 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with a clear diagnosis of chronic pancreatitis, pancreatic exocrine insufficiency (FE-1 <100 µg/g), and normal long-term blood sugar (HbA1c 4–6%) who have not previously used pancreatic enzyme replacement are the intended participants.
✕Probably not a fit
People with existing diabetes or prediabetes, prior or current pancreatic enzyme therapy, exocrine insufficiency from other surgeries, major liver or kidney disease, pregnancy, or active cancer are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an early-phase interventional study at Shanghai Changzheng Hospital giving pancreatin enteric-coated capsules (Creon) to adults with chronic pancreatitis and pancreatic exocrine insufficiency but normal HbA1c. Participants will have baseline measurements of glucose profiles, pancreatic endocrine and exocrine function, and gastrointestinal hormone levels, then receive pancreatic enzyme replacement and be re-measured to observe changes over time. The primary outcome is change in glucose profile; secondary outcomes include changes in pancreatic and gastrointestinal endocrine and exocrine markers. The protocol excludes people with diabetes, prior PERT use, major liver or renal disease, pregnancy, or other causes of exocrine insufficiency.
Why it matters
Potential benefit: If successful, replacing pancreatic enzymes could improve digestion-related hormone signals and stabilize post-meal blood sugar patterns in people with chronic pancreatitis and exocrine insufficiency.
How similar studies have gone: Some small studies and observational reports suggest pancreatic enzyme replacement can affect nutrient absorption and postprandial glucose, but randomized data are limited so the approach has preliminary support but remains unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China Recruiting -
Changzheng Hospital
Shanghai, China Not yet recruiting
Study contacts
- Study coordinator: Tuo Li, Doctor
- Email: dr.lituo@smmu.edu.cn
- Phone: 86-13918507887
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.