Unique ID issued by UMIN | UMIN000006254 |
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Receipt number | R000006724 |
Scientific Title | Metformin efficacy and safety for colorectal polyps: A double blind randomized controlled trial |
Date of disclosure of the study information | 2011/09/01 |
Last modified on | 2016/06/28 21:40:35 |
Metformin efficacy and safety for colorectal polyps: A double blind randomized controlled trial
Metformin efficacy and safety for colorectal polyps
Metformin efficacy and safety for colorectal polyps: A double blind randomized controlled trial
Metformin efficacy and safety for colorectal polyps
Japan |
Subjects after resection of colorectal polyps
Gastroenterology |
Others
NO
The aim of this study is to evaluate the chemopreventive effects and drug safety of metformin against metachronous colorectal polyps in nondiabetic post-polypectomy patients.
Safety,Efficacy
Confirmatory
Pragmatic
Phase III
The prevalence of colorectal polyps and number of polyps after 1-year intervention.
drug safety
body weight, body mass index (BMI)
laboratory data (fasting blood glucose, fasting blood insulin, HbA1c, total cholesterol, LDL-cholesterol, blood urea nitrogen (BUN), serum creatinine)
cell proliferative and apoptotic activities in colorectal epithelium and polyps
Expression levels of protein (AMPK, mTOR/S6K) of colorectal epithelium and polyps
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is considered as a block.
YES
Central registration
2
Prevention
Medicine |
Oral administration of metformin 250mg once daily for one year.
Oral administration of placebo tablet (lactose 250mg) once daily for one year.
40 | years-old | <= |
80 | years-old | > |
Male and Female
1) There is no colorectal polyps after polypectomy.
2) Written informed consent was obtained.
1) History of diabetes mellitus (use of medication and/or over HbA1c 6.5%)
2) History of regular NSAIDs and/or aspirin medication (defined as at least once per week)
3) History of bowel surgery
4) History of malignant disease (excluded carcinoma in adenoma, carcinoma in situ already had been resected)
5) History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure.
6) History of familial adenomatous polyposis
7) History of hereditary non-polyposis colorectal cancer
8) Histroy of inflammatory bowel disease
9) Women who are pregnant or with a possibility of pregnancy
10) Patients judged inappropriate for the trial by investigators
150
1st name | |
Middle name | |
Last name | Atsushi Nakajima |
Yokohama City University School of Medicine, Yokohama, Japan
Division of Gastroenterology
3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
045-787-2640
nakajima-tky@umin.ac.jp
1st name | |
Middle name | |
Last name | Takuma Higurashi |
Yokohama City University School of Medicine, Yokohama, Japan
Division of Gastroenterology
3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
045-787-2640
takuma_h@yokohama-cu.ac.jp
Division of Gastroenterology, Yokohama City University School of Medicine, Yokohama, Japan
Ministry of Health, Labour and Welfare
Third Research Project on General Strategy Against Cancer
Japanese Governmental office
Japan
Chigasaki Municipal Hospital, Kanagawa.
Tokyo Metropolitan Hiroo Hospital, Tokyo.
Yokohama Rosai Hospital, Kanagawa.
Hiratsuka City Hospital, Kanagawa.
Kanto Medical Center, NTT East, Tokyo.
NO
茅ケ崎市立病院(神奈川県)
都立広尾病院(東京都)
横浜労災病院(神奈川県)
平塚市民病院(神奈川県)
NTT東日本関東病院(東京都)
小田原市立病院(神奈川県)
2011 | Year | 09 | Month | 01 | Day |
http://bmccancer.biomedcentral.com/articles/10.1186/1471-2407-12-118
Published
http://www.sciencedirect.com/science/article/pii/S1470204515005653
Main results already published
2011 | Year | 07 | Month | 07 | Day |
2011 | Year | 09 | Month | 01 | Day |
2014 | Year | 12 | Month | 30 | Day |
2015 | Year | 03 | Month | 31 | Day |
2015 | Year | 05 | Month | 31 | Day |
2015 | Year | 07 | Month | 30 | Day |
2011 | Year | 08 | Month | 30 | Day |
2016 | Year | 06 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006724
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