Grant number: | 23/07137-3 |
Support Opportunities: | Scholarships in Brazil - Scientific Initiation |
Start date until: | June 01, 2023 |
End date until: | March 31, 2025 |
Field of knowledge: | Health Sciences - Medicine - Medical Clinics |
Principal Investigator: | Andrei Carvalho Sposito |
Grantee: | Marilia Paiva Martins |
Host Institution: | Faculdade de Ciências Médicas (FCM). Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil |
Associated research grant: | 13/07607-8 - OCRC - Obesity and Comorbidities Research Center, AP.CEPID |
Abstract Introduction: One of the biggest health challenges in the world is to reduce cardiovascular complications in patients with chronic kidney disease. Recent evidence has shown that gliflozins are associated with a reduced risk of death from cardiovascular causes in diabetic individuals. The potential extent of this benefit to dialysis patients is limited by the lack of safety studies for this group of patients. A recent analysis of our group revealed favorable pharmacokinetic and tolerability properties of dapagliflozin in dialysis patients. Considering the high prevalence of bone disease, osteoporosis and high propensity for fractures in this population, a safety study of dapagliflozin in bone tissue in dialysis patients is critical. Objectives: evaluate the effects of dapagliflozin on the bone of patients on hemodialysis and peritoneal dialysis, by evaluating the variation in bone mineral density measured using DXA and the occurrence of osteopenia/osteoporosis. Materials and Methods: prospective, open-label, randomized clinical trial for maintenance of standard care (control group) versus maintenance of standard care + dapagliflozin 10 mg orally/day (dapagliflozin group) for 24 weeks. Inclusion criteria: > 18 years, > 3 months on hemodialysis and clinical stability. Exclusion criteria: liver dysfunction, pregnancy or lactation, use of gliflozins, AMI in the last 2 months. Eighty patients will be randomized for the control and dapagliflozin groups, in a 1:1 ratio. The primary endpoint is the change in bone mineral density measured by DXA within and between groups, between baseline and end of 24 weeks. Hypothesis: It is expected that the use of dapagliflozin in dialysis patients is safe for bone tissue and, therefore, is associated with a non-significant variation in bone mineral density, when comparing the control and dapagliflozin groups. Therefore, it is also expected that there is no significant relationship between the use of dapagliflozin and the occurrence of osteopenia or osteoporosis in subjects with normal bone mineral density. | |
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