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The efficacy of additional metformin to aspirin for human rectal aberrant crypt foci: double-blinded randomized controlled trial

The efficacy of additional metformin to aspirin for human rectal aberrant crypt foci: double-blinded randomized controlled trial - The efficacy of aspirin and metformin for rectal ACF

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028259
Enrollment
60
Registered
2017-07-18
Start date
2017-07-18
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Patients with both colorectal ACF and resectable polyps

Interventions

receive 100mg aspirin and placebo for 8 weeks receive 100mg aspirin and 250mg metformin for 8 weeks

Sponsors

Yokohama City University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with resectable polyps. 2.Patients with more than 10 rectal ACF 3.Willingness to provide written informed consent

Exclusion criteria

Exclusion criteria: 1.Patients with lesion which preferred early resection. 2.History of regular use (defined as at least once per week) of NSAIDs and/or aspirin. 3.History of regular use of warfarin and/or DOAC. 4.History of diabetes mellitus (defined as more than HbA1c 6.5% or regular use of anti-diabetic drugs) . 5.History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure 6.History of familial adenomatous polyposis, hereditary non-polyposis colorectal cancer and inflammatory bowel disease 7.Pregnancy or possibility of pregnancy 8.Contraindication to aspirin or metformin 9.Allergy to aspirin or metformin 10.Patients judged as inappropriate candidates for the trial by the investigators

Design outcomes

Primary

MeasureTime frame
The amount of change rectal ACF in aspirin plus placebo group and aspirin plus metformin group after 8weeks intervention

Secondary

MeasureTime frame
The number of rectal ACF before and after intervention in both group Ki67 labeling index of colorectal adnoema/cancer and normal mucosa before and after intervention Safety

Countries

Japan

Contacts

Public ContactHigurashi Takuma

Yokohama City University Department of Gastroenterology and Hepatology

takuma_h@yokohama-cu.ac.jp045-787-2640

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026