Metformin efficacy and safety for colorectal polyps: A double blind randomized controlled trial

Conditions

Subjects after resection of colorectal polyps

Higurashi T, Hosono K, Takahashi H, Komiya Y, Umezawa S, Sakai E, Uchiyama T, Taniguchi L, Hata Y, Uchiyama S, Hattori A, Nagase H, Kessoku T, Arimoto J, Matsuhashi N, Inayama Y, Yamanaka S, Taguri M, Nakajima A.

2016-03-03251 citations

10.1016/s1470-2045(15)00565-3

Eicosapentaenoic acid (EPA) efficacy for colorectal aberrant crypt foci (ACF): a double-blind randomized controlled trial.

Higurashi T, Hosono K, Endo H, Takahashi H, Iida H, Uchiyama T, Ezuka A, Uchiyama S, Yamada E, Ohkubo H, Sakai E, Maeda S, Morita S, Natsumeda Y, Nagase H, Nakajima A.

2012-09-198 citations

10.1186/1471-2407-12-413

Metformin efficacy and safety for colorectal polyps: a double-blind randomized controlled trial.

Higurashi T, Takahashi H, Endo H, Hosono K, Yamada E, Ohkubo H, Sakai E, Uchiyama T, Hata Y, Fujisawa N, Uchiyama S, Ezuka A, Nagase H, Kessoku T, Matsuhashi N, Yamanaka S, Inayama Y, Morita S, Nakajima A.

2012-03-2645 citations

10.1186/1471-2407-12-118

Interventions

Oral administration of metformin 250mg once daily for one year. Oral administration of placebo tablet (lactose 250mg) once daily for one year.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) There is no colorectal polyps after polypectomy. 2) Written informed consent was obtained.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The prevalence of colorectal polyps and number of polyps after 1-year intervention.	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactTakuma Higurashi

Yokohama City University School of Medicine, Yokohama, Japan Division of Gastroenterology

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

Outcome results

None listed