Pancreatic enzyme treatment for blood sugar and digestion changes in chronic pancreatitis
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 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 |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Changzheng Hospital Academic / other |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Trial ID | NCT07314489 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality and 1 other locations
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.