ucent-J Study

Not Applicable

Recruiting

• Conditions: Type 2 diabetes mellitus; D003924

• Registration Number: JPRN-jRCTs051220016
• Lead Sponsor: Tamanaha Tamiko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1)Type 2 diabetic patients age 50 and over
2)Patients with HbA1c 8.5% or less (Most recent HbA1c within 13 weeks prior to consent)
3)Patients who received an ammonia PET examination before the date of consent acquisition, and MFR of 3.0 or less (Most recent MFR within 13 weeks prior to consent)
4)Patients with written consen

Exclusion Criteria

1) Patients with heart disease (myocardial infarction, cardiomyopathy, atrial fibrillation, severe valvular disease)
2) Patients who underwent cardiac bypass surgery or catheter treatment for ischemic heart disease within 13 weeks prior to consent
3) Patients with coronary artery disease who are indicated for coronary revascularization, or patients with suspected coronary artery disease who are indicated for coronary angiography
4) Persons with severe renal dysfunction
5) Patients with severe hepatic dysfunction (ALT or AST is 5 times or more of the standard value)
6) Patients with a malignant tumor currently being treated or during palliative care
7) Patients participating in or planning to participate in intervention studies using other medicines or medical devices
8) Smokers
9) Pregnant or lactating women
10) Patients with contraindications to luseogliflozin (hypersensitivity, severe ketosis, diabetic coma, severe infections, before or after surgery, serious trauma)
11) In the young old (65=12) Patients who received SGLT2 inhibitors from 13 weeks before the ammonia PET examination to the date of consent acquisition
13) Patients who have newly started or changed or discontinued diabetes treatment drugs, nitroglycer in preparations, vasodilators, and antihypertensive drugs within 13 weeks before obtaining consent. However, temporary drug changes are allowed due to suspected ischemia on ammonia PET scans.
14) Patients whose participation in this study is deemed inappropriate by the investigator or co-investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified