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

JRCT ID: jRCTs031180253

Registered date:13/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Colorectal adenoma, carcinoma in situ
• Date of first enrollment: 08/09/2017
• Target sample size: 60
• Study type: Interventional
• Intervention(s): medication

Outcome(s)

• Primary Outcome: The amount of change rectal ACF in aspirin plus placebo group and aspirin plus metformin group after 8weeks intervention

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both
• Include criteria: Patients both with rectal ACF and resectable polyps

Exclude 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

Related Information

• Primary Sponsor: Misawa Noboru
• Secondary Sponsor: Ministry of Health, Labour and Welfare
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology (MEXT),Public University Corporation Yokohama City University