Randomized controlled trial to evaluate the efficacy of Sodium glucose transporter 2 inhibitor in peritonealdialysis patients

Conditions

Chronic Kidney Disease

Naoko Matsuoka, Daigo Nakazawa, Saori Nishio, Kyu Yong Cho, Tomochika Maoka et al. (19 authors)

BMJ Open2024-11-01

10.1136/bmjopen-2024-084846

Effects of sodium-glucose co-transporter 2 inhibitors on ultrafiltration in patients with peritoneal dialysis: a protocol for a randomized, double-blind, placebo-controlled, crossover trial (EMPOWERED).

Doi Y, Shinzawa M, Arisato T, Oka H, Matsumoto A, Kitamura H, Nakazono Y, Nishiya Y, Ueda Y, Kamimura T, Hayashi T, Yoshihara F, Isaka Y.

2024-02-256 citations

10.1007/s10157-024-02467-w

Interventions

After consent and registering patients,registration will be assigned by the next visit (week0) or on the day of the visit at week 0. Blood test is performed on the visit day (week 0), and the group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who is over 20 years old Patients diagnosed with type 2 diabetes Patients from whom written informed consent was obtained

Exclusion criteria

Exclusion criteria: Patients who undergo PD less than 3 months Patients with unstable blood pressure Patients deemed inadequate for monitoring during study period, as determined by investigator s.

Design outcomes

Primary

Measure	Time frame
BNP	—

Secondary

Measure	Time frame
1)The following rate of change between 0 week and each point of time in the prior group and control group 1. glycemic control and HbA1c 2. treatment of peritoneal dyalisis (peritoneal dialysis fluid , KT/Vurea , water removal, amount of ESA ) 3. cardiac ultrasound and cardiothoracic ratio 4. holter ECG ,Carotid Ultrasound, and CT 5. CVD biomarker 6. oxidative stress marker 7. bone metabolism markers 8. bone mineral density 9. blood pressure, body weight, BMI 2)BNP at other time points and BNP change amount at each point 3) The following rate of change comparing the time points of each test before and after administration of canagliflozin 1. glycemic control and HbA1c 2. treatment of peritoneal dyalisis (peritoneal dialysis fluid , KT/Vurea , water removal, amount of ESA) 3. cardiac ultrasound and cardiothoracic ratio 4. holter ECG ,Carotid Ultrasound, and CT 5. CVD biomarker 6. oxidative stress marker 7. bone metabolism markers 8. bone mineral density 9. blood pressure, body weight, BMI 10. BNP	—

Measure

Time frame

1)The following rate of change between 0 week and each point of time in the prior group and control group 1. glycemic control and HbA1c 2. treatment of peritoneal dyalisis (peritoneal dialysis fluid , KT/Vurea , water removal, amount of ESA ) 3. cardiac ultrasound and cardiothoracic ratio 4. holter ECG ,Carotid Ultrasound, and CT 5. CVD biomarker 6. oxidative stress marker 7. bone metabolism markers 8. bone mineral density 9. blood pressure, body weight, BMI 2)BNP at other time points and BNP change amount at each point 3) The following rate of change comparing the time points of each test before and after administration of canagliflozin 1. glycemic control and HbA1c 2. treatment of peritoneal dyalisis (peritoneal dialysis fluid , KT/Vurea , water removal, amount of ESA) 3. cardiac ultrasound and cardiothoracic ratio 4. holter ECG ,Carotid Ultrasound, and CT 5. CVD biomarker 6. oxidative stress marker 7. bone metabolism markers 8. bone mineral density 9. blood pressure, body weight, BMI 10. BNP

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Contacts

Public ContactNaoko Matsuoka

Hokkaido university hospital

mnaoko2014@gmail.com+81-117161161

Outcome results

None listed