Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01725490
Other study ID # 4-2012-0491
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 15, 2013
Est. completion date August 30, 2020

Study information

Verified date September 2021
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Familial adenomatous polyposis (FAP) leads to adenomas and eventual adenocarcinomas in colon and less frequently, duodenum. Chemopreventive strategies have been studied in FAP patients to delay the development of adenomas and cancers. The non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase-2 inhibitor have shown the regression of colorectal and duodenal adenomas in FAP patients. However, these drugs showed gastrointestinal damage and cardiovascular risks, and new preventive strategies are needed. Metformin, a biguanide, which is widely used for treating diabetes mellitus, has recently been suggested to have a suppressive effect on tumorigenesis via mTOR-inhibiting pathway, and have no significant safety issues in long term use. The investigators devised a double-blind randomized controlled trial to evaluate the effect of metformin on polyps of colorectum and duodenum in non-diabetic FAP patients.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date August 30, 2020
Est. primary completion date August 30, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: 1. Patients with familial adenomatous polyposis(FAP) who are 20 to 65 years of age. 2. FAP patients who have colonic or duodenal polyp 3. FAP patients who have five or more polyps 2mm or more in diameter in endoscopic examination. Exclusion Criteria: 1. FAP patients who had a history of colectomy within the previous 12 months or need to undergo colectomy within 8 months after randomization. 2. FAP patients with malignant disease, including colorectal cancer. 3. FAP patients who used NSAIDs (non-steroidal anti-inflammatory drugs) or aspirin three or more times a week within 6 months of randomization. 4. FAP patients with diabetes mellitus. 5. Pregnant or breast-feeding patients. 6. Patients with abnormal results of serum laboratory tests (renal function and liver function test) and significant infectious or respiratory diseases.

Study Design


Intervention

Drug:
Metformin
Patients will be randomly assigned in a 2:2:1 ratio to receive metformin or identical-appearing placebo tablets orally for 7 months: metformin 500mg once and placebo twice a day in arm A, metformin 500mg three times a day in arm B, and placebo three times a day in arm C.
Metformin
Patients will be randomly assigned in a 2:2:1 ratio to receive metformin or identical-appearing placebo tablets orally for 7 months: metformin 500mg once and placebo twice a day in arm A, metformin 500mg three times a day in arm B, and placebo three times a day in arm C.
Placebo
Patients will be randomly assigned in a 2:2:1 ratio to receive metformin or identical-appearing placebo tablets orally for 7 months: metformin 500mg once and placebo twice a day in arm A, metformin 500mg three times a day in arm B, and placebo three times a day in arm C.

Locations

Country Name City State
Korea, Republic of Department of Internal Medicine, Yonsei University College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary the mean percentage change of the number and size of polyps in colon and/or duodenum. At the base-line endoscopy, India-ink tattoo will be placed in the ascending colon, sigmoid colon/rectum, and duodenum. In case of patient with retained rectum after colectomy and ileorectal anastomosis, sigmoidoscopy will be performed. The base-line and seven-month endoscopic examination will be recorded, and photographs will be taken at the tattoo-marked area and used for measurements of the number and size of polyps. The diameter of a polyp will be measured with the aid of biopsy forceps included in the photographic field, and only distinct polyps at least 2 mm in diameter will be counted. After seven-month administration of metformin/placebo, colonoscopy/sigmoidoscopy and upper gastrointestinal endoscopy will be performed.
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05630794 - Testing ONC201 to Prevent Colorectal Cancer Phase 1
Completed NCT02961374 - Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer Phase 2
Completed NCT01483144 - Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP) Phase 3
Completed NCT00641147 - Curcumin in Treating Patients With Familial Adenomatous Polyposis Phase 2
Recruiting NCT03471403 - Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis
Not yet recruiting NCT04531930 - Colorectal Adenoma Canceration in FAP
Recruiting NCT04677998 - A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis
Recruiting NCT04678011 - A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy
Completed NCT00927485 - Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP) N/A
Recruiting NCT00253812 - Adenoma Detection Rate:NBI, AFI, Chromoscopic or Standard Endoscopy N/A
Withdrawn NCT00248053 - Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis Patients Phase 2
Recruiting NCT02012699 - Integrated Cancer Repository for Cancer Research
Completed NCT04674228 - Review of Post-Study Clinical Endoscopy Reports in Follow Up to MAY2016-07-01
Completed NCT01656746 - Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease N/A
Completed NCT00808743 - Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis Phase 2/Phase 3
Active, not recruiting NCT03847636 - CryoBalloon Ablation for Treatment of Duodenal Adenomas N/A
Not yet recruiting NCT05112822 - Testing Obeticholic Acid (OCA) for Familial Adenomatous Polyposis (FAP) Phase 1
Recruiting NCT02656134 - Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis (FAP) N/A
Withdrawn NCT01245816 - A Trial of Low Dose Sulindac Combined With Eflornithine in Patients With Familial Adenomatous Polyposis (FAP) Phase 3
Recruiting NCT04709445 - Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses N/A