Pleiotropic Effects of Sodium glucose co-transporter 2 inhibitor on sympathetic nerve activity and organ network in patients with Type 2 diabetes

Not Applicable

Recruiting

• Conditions: Type2 diabetes patients with multiple atherosclerosis risk factors; Type2 diabetes; D003924

• Registration Number: JPRN-jRCTs041200035
• Lead Sponsor: TAKAMURA Toshinari

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

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

Inclusion Criteria

Main inclusion criteria
Previous history of cardiovascular diseases, ischemic stroke, and heart failure. And/or at least one of the following conditions (Hypertension, dyslipidemia, high age(male: above 50, female: above 55), smoking history, obesity (BMI above 25)).
Type 2 diabetes, HbA1c >=7.0%

Exclusion Criteria

Main exclusion criteria
1) luseogliflozin or glimepiride hypersensitivity or contraindications, 2) treatment with glinide, sulfonylurea, and SGLT2 inhibitor including luseogliflozin within 4 weeks of screening, 3) type 1 diabetes or gestational diabetes, 4) diabetic ketoacidosis, hyperosmolar hyperglycemic state, and poorly controlled unstable diabetes (ketoacidosis or an increase in HbA1c of >3% in the 12 weeks before screening), 5) Absolute indications for insulin therapy (Severely infected states, scheduled operation, severe trauma, and so on), 6) history of symptoms of hypoglycemia, 7) poorly controlled hypertension or systolic blood pressure of >160 mmHg or diastolic blood pressure of >100 mmHg, 8) severe retinopathy requiring immediate treatment, 9) during the treatment of malignancy, 10) presence of a severe health problem, not being suitable for the study,11) pregnant or breastfeeding, and 12) inability to participate in the study (including psychiatric and psychosocial problems), as assessed by the investigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in muscle sympathetic nerve activity (MSNA, Burst Frequency bursts/minute)