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NCT Number: NCT07314489

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

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.

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Key information

Conditions

Chronic Pancreatitis Pancreatic Exocrine Insufficiency Blood Glucose Chronic Disease Digestive System Diseases Disease Attributes Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Shanghai Changzheng Hospital, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. The changes in glucose profile before and after pancreatic enzyme intervention

    Time frame: 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.

    Time frame: From enrollment to 3 months after pancreatic enzyme intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Tuo Li, Doctor

CONTACT

[email protected]

86-13918507887

Sponsors and collaborators

Lead sponsor

Shanghai Changzheng Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2035
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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