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A randomized controlled study to evaluate the effect of metformin on abnormal crypt inhibition after resection of high-risk colorectal adenomas

A randomized controlled study to evaluate the effect of metformin on abnormal crypt inhibition after resection of high-risk colorectal adenomas

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105089
Enrollment
Unknown
Registered
2025-06-27
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk colorectal adenoma

Interventions

Low-dose test group:Low-dose metformin, 250 mg/day for 1 month
Medium-dose test group:Medium-dose metformin, 500 mg/day for 1 month
High-dose test group:High-dose metformin, 1000 mg/day for 1 month
Control-group:placebo

Sponsors

The Tenth People's Hospital Affiliated to Tongji University (Shanghai Tenth People's Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. There was no residual polyp in the second colonoscopy after colorectal adenoma resection; 2. The adenoma resected for the first time has one of the following characteristics: >=10mm, >=3, adenoma with more than 25% villous content or accompanied by high-grade neoplastic adenoma; 3. > = 5 rectal ACFs; 4. Age between 40-80 years old; 5. Willing to sign the informed consent form for enrollment.

Exclusion criteria

Exclusion criteria: 1. History of diabetes mellitus (use of diabetes medications or HbA1 >6.5%); 2. Have a history of metformin allergy or cannot tolerate its side effects; 3. History of taking non-steroidal anti-inflammatory drugs, COX2 inhibitors, berberine hydrochloride, calcium supplements, and vitamin D in the past six months, and the above drugs are also excluded during the study; 4. History of colorectal surgery; 5. History of malignant tumors (excluding lesions that have been endoscopically resected); 6. Suffering from serious diseases such as heart failure, liver failure, kidney failure and liver cirrhosis; 7. Familial adenomatous polyposis; 8. Have a history of inflammatory bowel disease; 9. Women who are pregnant, breastfeeding, or expecting to become pregnant; 10. Poor quality of bowel preparation (Boston score < 6); 11. Patients who, in the opinion of the investigators, are not suitable for participation.

Design outcomes

Primary

MeasureTime frame
Proportion of decline in the number of abnormal crypts;

Secondary

MeasureTime frame
Proportion of declines in different types of ACF;Effect of metformin on insulin resistance and blood lipids;

Countries

China

Contacts

Public ContactFeng Liu

The Tenth People's Hospital Affiliated to Tongji University (Shanghai Tenth People's Hospital)

drliuffeng@hotmail.com+86 136 8197 3214

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026