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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2035-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2

NCT02009410

Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2

WITHDRAWN PHASE4

Relation of Glucose and Acute Pancreatitis

NCT01470885

Acute Pancreatitis

COMPLETED

Clinical Study on the Safety and Efficacy of Immunophenotyped Pancreatic Endocrine Organoid Bank in Treating Patients With T3c Diabetes

NCT06991829

Diabetes Mellitus

ACTIVE_NOT_RECRUITING EARLY_PHASE1

Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes

NCT05266963

Type 1 Diabetes

COMPLETED EARLY_PHASE1

Intravenous Administration of Insulin and Plasma Exchange on Triglyceride Levels in Early Stage of Hypertriglyceridemia-induced Pancreatitis

NCT03342807

Pancreatitis, Acute Hypertriglyceridemia

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pancreatitis Pancreatic Exocrine Insufficiency Blood Glucose

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Creon（Pancreatin Enteric-coated Capsules）

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

Group Type ACTIVE_COMPARATOR

Creon（Pancreatin Enteric-coated Capsules）

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Creon（Pancreatin Enteric-coated Capsules）

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes