UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Metformin efficacy and safety for colorectal polyps: A double blind randomized controlled trial
Title of the study (Brief title)	Metformin efficacy and safety for colorectal polyps
Region	Japan

Condition
Condition	Subjects after resection of colorectal polyps
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	The prevalence of colorectal polyps and number of polyps after 1-year intervention.
Key secondary outcomes	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Oral administration of metformin 250mg once daily for one year.
Interventions/Control_2	Oral administration of placebo tablet (lactose 250mg) once daily for one year.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) There is no colorectal polyps after polypectomy. 2) Written informed consent was obtained.
Key exclusion criteria	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
Target sample size	150

Research contact person
Name of lead principal investigator	Atsushi Nakajima
Organization	Yokohama City University School of Medicine, Yokohama, Japan
Division name	Division of Gastroenterology
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL	045-787-2640
Email	nakajima-tky@umin.ac.jp

Public contact
Name of contact person	Takuma Higurashi
Organization	Yokohama City University School of Medicine, Yokohama, Japan
Division name	Division of Gastroenterology
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL	045-787-2640
Homepage URL
Email	takuma_h@yokohama-cu.ac.jp

Sponsor
Institute	Division of Gastroenterology, Yokohama City University School of Medicine, Yokohama, Japan
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Ministry of Health, Labour and Welfare Third Research Project on General Strategy Against Cancer
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Chigasaki Municipal Hospital, Kanagawa. Tokyo Metropolitan Hiroo Hospital, Tokyo. Yokohama Rosai Hospital, Kanagawa. Hiratsuka City Hospital, Kanagawa. Kanto Medical Center, NTT East, Tokyo.
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	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）

Other administrative information
Date of disclosure of the study information	2011 Year 09 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 07 Month 07 Day
Anticipated trial start date	2011 Year 09 Month 01 Day
Last follow-up date	2014 Year 12 Month 30 Day
Date of closure to data entry	2015 Year 03 Month 31 Day
Date trial data considered complete	2015 Year 05 Month 31 Day
Date analysis concluded	2015 Year 07 Month 30 Day

Related information
URL releasing protocol	http://bmccancer.biomedcentral.com/articles/10.1186/1471-2407-12-118
Publication of results	Published
URL releasing results	http://www.sciencedirect.com/science/article/pii/S1470204515005653
Results
Other related information

Management information
Registered date	2011 Year 08 Month 30 Day
Last modified on	2016 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006724