Type 2 diabetes
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Type 2 diabetes who have inadequate glycemic control(HbA1c between 6.5 and 12.0%) under medical treatment by dieting and exercise cure and/or drug treatment. 2)Over 20 years old and less than 80 years old 3)Sex unquestioned 4)Patients with no history of cardiovascular disease 5)No treatment or treatment with stable doses of antihypertensive and antiplatelet agents for at least 3 months prior to randomization. 6)The patient who gives a written informed
Exclusion criteria
Exclusion criteria: 1)Type 1 diabetes 2)Liver dysfunction (hepatic enzymes more than three times the upper limit of normal ranges) 3)A pregnant woman and/or a woman under breast-feeding 4)Impaired kidney function (serum crearinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women) 5)Diabetic proliferative retinopathy 6)The patients who has an anamnesis of hypersensitivity to the ingredient of a trial drug 7)Patient with intolerance of medical reasons by doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical significance of serum chemokine levels in patient with diabetes and diabetic neuropathy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of measurement: early in the morning, fasting Measurement items (LSI): CCL11 (eotaxin) CCL22 (MDC) IL-6 IL-18 Urine Metabolomics U-NGAL serum: FGF21 BDNF HMW adiponectin IL-33s TNF-R1 & -R2 Relationship with diabetic complications: peripheral neuropathy: staging, nerve conduction test, CVR-R Orthostatic hypotension (Sheron test) Timed up and Go test, Monofilament Nephropathy: eGFR UAE Retinopathy: Stage Relationship with insulin resistance: BMI, InBody, DualScan Relationship with arteriosclerosis: CAVI / ABI FMD carotid IMT Routine examination at admission + IgE + TARC + Beta-hydroxyl-butyrate + M2BPG (i Mac-2 binding protein sugar chain modification isomer), Ca, P, active Vitamin D3 Heart rate variability (HRV): CVR-R, power spectrum analysis (PSA) The severity of diabetic kidney disease Coagulation fibrinolysis system: vWF, d dimer, etc. Arterial stiffness: PWV, CAVI abdominal echo | — |
Countries
Japan
Contacts
Dokkyo Medical University Department of Endocrinology and Metabolism