JRCT ID: jRCTs051200115
Registered date:19/01/2021
Novel gastrointestinal-mediated mechanism of action of metformin
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Patients with type 2 diabetes |
Date of first enrollment | 08/03/2021 |
Target sample size | 5 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | magnetic resonance enterography |
Outcome(s)
Primary Outcome | FDG excretion per hour into the intestinal lumen |
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Secondary Outcome | HbA1c, plasma glucose levels and various clinical parameters Presence or absence of disease |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1.Patients with type 2 diabetes 2.Patients taking more than 1000 mg of metformin hydrochloride per day 3.Patients with no obvious lesions in the lower gastrointestinal tract 4.Patients who were 20 years of age or older and Under 75 years old at the time of obtaining consent 5.Patients who have given their voluntary written consent to participate in this clinical study |
Exclude criteria | 1.Patients with contraindications to scopolamine butylbromide 2.Patients suffering from dementia or mental illness 3.Patients with possible bowel perforation or obstruction 4.Patients with metals in the body that are not amenable to PET/MRE testing 5.Pregnant or breast feeding patients 6.Other patients who are deemed inappropriate by the investigators of this clinical study |
Related Information
Primary Sponsor | Sakaguchi Kazuhiko |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Jun Ito |
Address | 7-5-2 Kusunoki-cho,Chuo-ku,Kobe,Hyogo Hyogo Japan 650-0017 |
Telephone | +81-78-382-5861 |
karen@med.kobe-u.ac.jp | |
Affiliation | Kobe University Hospital |
Scientific contact | |
Name | Kazuhiko Sakaguchi |
Address | 7-5-2 Kusunoki-cho,Chuo-ku,Kobe,Hyogo Hyogo Japan 650-0017 |
Telephone | +81-78-382-5861 |
kzhkskgc@med.kobe-u.ac.jp | |
Affiliation | Kobe University Hospital |