Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
NCT07314489

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

Led by Shanghai Changzheng Hospital · Updated on 2026-01-02

80

Participants Needed

2

Research Sites

560 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female Chinese subjects aged 18 years or older
  • Clear diagnosis of chronic pancreatitis
  • Glycated hemoglobin (HbA1c) levels between 4% and 6%
  • Fecal elastase-1 (FE-1) less than 100 µg/g
Not Eligible

You will not qualify if you...

  • History of diabetes or prediabetes, or HbA1c equal to or above 6.0%, or fasting venous glucose equal to or above 6.1 mmol/L
  • Positive for islet-related antibodies
  • Currently receiving or previously received pancreatic enzyme replacement therapy
  • Allergy to components of pancreatic enzyme replacement therapy drugs
  • Exocrine pancreatic insufficiency caused by other reasons such as post-gastrectomy or post-intestinal resection
  • Undergoing pancreatic surgery other than endoscopic retrograde cholangiopancreatography (ERCP)
  • Renal disease at stage G3, G4, or G5
  • Decompensated chronic liver disease
  • Receiving glucocorticoid therapy
  • Pregnant or breastfeeding women
  • Patients with malignant tumors

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China, 200003

Actively Recruiting

2

Changzheng Hospital

Shanghai, China, 200003

Not Yet Recruiting

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Research Team

T

Tuo Li, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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