Effects of the SGLT2 inhibitor on erythropoiesis and iron homeostasis in patients with type 2 diabetes and chronic kidney disease
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- JPRN-UMIN000043519
- Lead Sponsor
- aka Kinen Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 14
Not provided
1.Type 1 diabetes 2.Patients with severe ketosis, diabetic coma or pre-coma, severe infection, perioperative, or severe trauma 3.Patients with severe renal dysfunction or treated with hemodialysis for end-stage renal disease 4.History of acute coronary syndrome, cerebrovascular disease, myocarditis, contractile pericarditis, or severe valvular disease within 12 weeks before consent 5.NYHA cardiac function classification of IV 6.BMI <18.5 kg/m2 7.Pregnant, breast-feeding, or possibly pregnant women 8.Diagnosed or suspected malignant tumors (patients who do not have a treatment history of anticancer therapy within 1 year before consent, and have no plan to do so will not be excluded) 9.Patients in the study is judged by the investigator or sub-investigator as inappropriate for any other reason
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes of parameters of the erythropoiesis (RBCs, Hb, Hct, CHr, EPO, MCV) and iron homeostasis (ferritin, TSAT, hepcidin) at 12 weeks after dapagliflozin administration
- Secondary Outcome Measures
Name Time Method Changes of several parameters at 12 weeks after dapagliflozin administration 1.BIA and body composition analysis 2.HbA1c and BMI 3.Uric acid, Cre, eGFR, UACR, and urine sodium 4.AST, ALT, and gamma-GTP 5.Total, HDL, and LDL cholesterol, and TG 6.Severe adverse events