The efficacy of additional metformin to aspirin for human rectal aberrant crypt foci: double-blinded randomized controlled trial
Phase 2
Recruiting
- Conditions
- Patients with both colorectal ACF and resectable polyps
- Registration Number
- JPRN-UMIN000028259
- Lead Sponsor
- Yokohama City University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The amount of change rectal ACF in aspirin plus placebo group and aspirin plus metformin group after 8weeks intervention
- Secondary Outcome Measures
Name Time Method 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