Metformin Intestinal Prospective Study

JRCT ID: jRCT1051210063

Registered date:13/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 13/08/2021
• Target sample size: 30
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Gene expression level of GLUT2 (Glucose transporter 2)
• Secondary Outcome: Expression site of GLUT2 (luminal side, basement membrane side)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Sakaguchi Kazuhiko
• Source(s) of Monetary Support: Manpei Suzuki Diabetes Foundation