臨床研究等提出・公開システム

A Prospective Interventional Study on the Mechanism of Metformin Action Using Intestinal Mucosal Biopsy Tissue from Type 2 Diabetic Patients

Metformin Intestinal Prospective Study

Sakaguchi Kazuhiko

Kobe University Graduate School of Medicine

7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo.

kzhkskgc@med.kobe-u.ac.jp

Ito Jun

Kobe University Hospital

7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo.

+81-78-382-5861

karen@med.kobe-u.ac.jp

Recruiting

Aug. 13, 2021

Interventional

non-randomized controlled trial

open(masking not used)

active control

single assignment

treatment purpose

Metformin oral group
1. patients scheduled to undergo lower gastrointestinal endoscopy
2. patients with type 2 diabetes who have been taking metformin at least 1000 mg/day for more than 1 month
3. patients who are expected to take no less than 1000 mg/day of metformin until they undergo lower gastrointestinal endoscopy
4. patients aged 20 years or older but less than 75 years.
5. patients who have given their written consent for the study.
Metformin non-medication group
1. patients scheduled to undergo lower gastrointestinal endoscopy
2. patients with type 2 diabetes who have not taken metformin for more than 1 month.
3. patients who are not expected to start metformin for a period of time before undergoing lower gastrointestinal endoscopy
4. patients aged 20 years or older but less than 75 years.
5. patients who have given their written consent for the study.

1. pregnant women, lactating women, and women who may become pregnant.
2. patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis) or with a history of such disease.
3. patients with a history of gastrointestinal tract surgery (excluding endoscopic mucosal resection)
4. patients with suspected gastrointestinal tract infections
5. patients with predisposition to bleeding (platelet abnormality: von Willebrand disease, coagulation abnormality: hemophilia, vascular abnormality: IgA) Vascular abnormalities: IgA vasculitis, etc.)
6. patients taking two or more anticoagulants or antiplatelet agents
7. patients suffering from dementia or psychiatric disease
8. patients with HBV, HCV, or HIV.
9. other patients who are judged to be inappropriate by the person in charge of this study.

Both

type 2 diabetes

Obtain biopsy tissue from four or more locations from the ileum or descending colon that the gastrointestinal endoscopist determines to be normal mucosa using standard biopsy forceps.

diabetes

biopsy

D003924

Gene expression level of GLUT2 (Glucose transporter 2)

Expression site of GLUT2 (luminal side, basement membrane side)

+81-78-382-6669

June. 23, 2021

No

none