Chronic Kidney Diseases, Diabetes Type 2
Conditions
Brief summary
the effect of Dapagliflozin on erythropoiesis, iron metabolism and inflammatory markers in CKD with Type 2 DM-Compare between effect of placebo and dapagliflozin on erythropoiesis, iron metabolism and inflammation markers in CKD with Type 2 DM.
Detailed description
Type 2 diabetes is considered an important cause of chronic kidney diseases (CKD) ,in those patients the inflammation is the most assumed cause of the decrease in erythropoietin synthesis and abnormal iron metabolism leading to anemia (1\_3). Sodium glucose cotransporter 2 (SGLT2) inhibitors like Dapagliflozin are oral medications approved for type 2 diabetes. interestingly, during recent years, they have been promisingly considered as anew medications for cardiovascular and kidney diseases (4). Researchers suggested that SGLT 2 inhibitors play an important role in reducing CKD progression and renal failure with patients with type 2 DM based on the clinical outcomes and laboratory findings rather than completely understood mechanism (5\_8) Investigators reported that reduced transferrin saturation (TSAT), ferritin and hepcidin and circulating and urinary inflammatory mediators, including monocyte chemoattractant protein-1 (MCP -1 ) and interleukin-6 (IL-6) transiently increased EPO suggesting SGLT 2 inhibition may help iron utilization and promote erythropoiesis decreasing anemia ( 9-14) Here we are studying the effects of the SGLT 2 inhibitor Dapagliflozin regarding markers of erythropoiesis, iron metabolism and inflammation in patients with Type 2 DM and CKD.
Interventions
patient will recive dapagliflozin for 24 week to improvement of eGFR on CKD patients
DRUGPlacebo
type 2 diabetic patients with chronic kidney diseases will recive placebo for 24 weeks
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Eligible participants were aged \>18 years and diagnosed with Type 2 diabetes participants we required to have urinary albumin-creatinine ratio (UACR ) of 30\_3500 mg /g ,eGFR of 20\_ 80 ml/min/ 1.73 m , and HbA1c of 7.0 \_ 11.0 % at screening
Exclusion criteria
type 1 diabetes, non-diabetes kidney disease and patient with HB \< 9
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GFR in CKD patients | 6 months | Measure eGFR using ckd epi equation to detect the effect of dapagliflozin in improvement of GFR in CKD patients |
Contacts
Primary Contactzeinab khodary, master
Backup ContactMai Mostafa, MD
Outcome results
None listed