Status:
RECRUITING
Metformin in Post Chronic Pancreatitis Diabetes Mellitus
Lead Sponsor:
Changhai Hospital
Conditions:
Chronic Pancreatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to evaluate the efficacy and safety of metformin in treating patients with post chronic pancreatitis diabetes mellitus (PPDM-C). The main questions it aims to answer...
Detailed Description
Chronic pancreatitis (CP) is an irreversible chronic fibro-inflammatory disease caused by multiple factors. Patients often present with recurrent upper abdominal pain, dyspepsia, steatorrhea, and othe...
Eligibility Criteria
Inclusion
- Aged 18-65 years, any sex.
- Patients diagnosed with chronic pancreatitis.
- Diagnose diabetes at least 3 months after chronic pancreatitis diagnosis.
- Never used any diabetes drug/glucose-lowering medication or had discontinued any glucose-lowering medications for at least 8 weeks prior to screening.
- HbA1c criteria: 7.5%\~9.0%.
- BMI \>18.5.
- Provision of signed informed consent.
Exclusion
- Type 1 diabetes or secondary diabetes not caused by chronic pancreatitis (e.g. diabetes due to monogenic defects, cystic fibrosis, medications, autoimmune diseases, stress, or other factors).
- Contraindications or history of intolerance or allergy to metformin.
- Fasting C-peptide \<0.3 nmol/L.
- Acute episodes of chronic pancreatitis at enrollment or within 3 months prior to enrollment.
- History of congestive heart failure (NYHA class 3 or greater), unstable angina, or other severe cardiovascular diseases.
- History of cancer (except non-melanoma skin cancer) within 5 years prior to screening.
- History of partial or total pancreatectomy.
- History of or planning bariatric surgery.
- Previous organ transplantation.
- Treatment with oral or systemic glucocorticoids within 3 months prior to enrollment or plan to use during the study (inhaled steroids are permitted).
- History of hemolytic anemia, chronic transfusion requirements, or other conditions rendering HbA1c results unreliable.
- Other conditions requiring glucose-lowering medications, such as polycystic ovary syndrome.
- Fasting blood glucose \>11.1 mmol/L during screening, requiring immediate treatment as judged by the physician.
- Sever psychiatric disorders or health conditions deemed unsuitable for clinical research participation.
- Pregnancy or plans for pregnancy during the course of the study.
- Any other condition considered by the investigator to be inappropriate for participation in the trial.
Key Trial Info
Start Date :
April 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT06937294
Start Date
April 28 2025
End Date
January 31 2026
Last Update
May 21 2025
Active Locations (1)
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1
Changhai Hospital
Shanghai, Shanghai Municipality, China