Actively Recruiting
Metformin in Post Chronic Pancreatitis Diabetes Mellitus
Led by Changhai Hospital · Updated on 2025-05-21
58
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 are: * What is the efficacy of metformin in glycemic control in patients with PPDM-C? * What is the incidence of adverse effects associated with metformin in patients with PPDM-C? Participants will be randomly assigned to receive either metformin or a placebo to see if metformin provides significant glycemic control and to assess the safety profile of the treatment.
CONDITIONS
Official Title
Metformin in Post Chronic Pancreatitis Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years, any sex
- Diagnosed with chronic pancreatitis
- Diagnosed with diabetes at least 3 months after chronic pancreatitis diagnosis
- Never used diabetes or glucose-lowering drugs, or stopped such medications at least 8 weeks before screening
- HbA1c between 7.5% and 9.0%
- Body mass index (BMI) greater than 18.5
- Signed informed consent provided
You will not qualify if you...
- Type 1 diabetes or diabetes caused by factors other than chronic pancreatitis
- Allergy, intolerance, or contraindication to metformin
- Fasting C-peptide less than 0.3 nmol/L
- Acute chronic pancreatitis episodes at enrollment or within 3 months before enrollment
- Severe cardiovascular diseases such as congestive heart failure (NYHA class 3 or higher) or unstable angina
- Cancer history (except non-melanoma skin cancer) within 5 years before screening
- History of partial or total pancreas removal
- History of or planned bariatric surgery
- Previous organ transplantation
- Oral or systemic glucocorticoid treatment within 3 months before enrollment or planned during study (inhaled steroids allowed)
- History of hemolytic anemia or conditions affecting HbA1c reliability
- Other conditions requiring glucose-lowering medications like polycystic ovary syndrome
- Fasting blood glucose above 11.1 mmol/L requiring immediate treatment
- Severe psychiatric disorders or health issues unsuitable for study participation
- Pregnancy or plans to become pregnant during the study
- Any other condition judged by the investigator as inappropriate for the trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
Changhai Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
L
Lianghao Hu, M.D.
CONTACT
X
Xiaoyu Zhou, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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