Type2 diabetes patients with multiple atherosclerosis risk factors Type2 diabetes
Conditions
Interventions
SGLT2 inhibitor
Sponsors
TAKAMURA Toshinari
TAISHO PHARMACEUTICAL CO.,LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in muscle sympathetic nerve activity (MSNA, Burst Frequency bursts/minute) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. BF and BI from the beginning to 12 weeks of treatment 2. BI from the beginning to 24 weeks of treatment 3. BRS by MSNA and CVR-R interval 4. Cardiac autonomic nerve activity 5. organ-specific insulin sensitivity, estimated by the hyperinsulinemic euglycemic clamp study using an artificial pancreas 6. oxidative and non-oxidative glucose metabolism, calculated by indirect calorimetry 7. basal metabolism and respiration quotient, calculated by indirect calorimetry 8. Heart rate and blood pressure 9. body compositions 10. blood glucose and insulin sensitivity (fasting plasma glucose levels, hemoglobin A1c, glycated albumin, immunoreactive insulin, homeostasis model assessment of insulin resistance, quantitative insulin sensitivity check index, C-peptide immunoreactivity), 11. lipid metabolism 12. renal function and electrolyte balances 13. bone metabolism 14. adrenal hormone (plasma renin activity, plasma aldosterone levels, plasma catecholamine (adrenaline, noradrenaline, and metanephrines) levels, urinary epinephrine, norepinephrine, metanephrine and normetanephrine) 15. oxidative stress (Fe, Ferritin) levels 16. cytokine concentration (leptin, adiponectin) 17. hepatokines (selenoprotein P and LECT-2) levels 18. Evaluation of Safety 19. Iodine-123 metaiodobenzylguanidine (123I-MIBG) scintigraphy of heart, renal, and Liver (washout rate, H/M ratio, K/BG ratio, L/M ratio) 20. left ventricular ejection fraction, diastolic capacity, and cardiac load by evaluating echocardiography 21. endothelial functions (EndoPAT) 22. Relation between organ specific sympathetic nerve activity and organ specific insulin sensitivity 23. Genes expression related to glucose and lipid metabolism. | — |
Contacts
Public ContactYumie Takeshita
Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.
Outcome results
None listed