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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | type 2 diabetic patients with chronic kidney diseases will recive dapagliflozin |
|
| Group B | Placebo Comparator | type 2 diabetic patients with chronic kidney diseases will recive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin (DAPA) | Drug | patient will recive dapagliflozin for 24 week to improvement of eGFR on CKD patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| GFR in CKD patients | Measure eGFR using ckd epi equation to detect the effect of dapagliflozin in improvement of GFR in CKD patients | 6 months |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zeinab khodary, master | Contact | +201500009366 | zynapkhodary@gmail.com | |
| Mai Mostafa, MD | Contact | +201223971678 | Mai_heamatology@aun.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Mai Mostafa, MD | professor | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38017482 | Result | Koshino A, Neuen BL, Jongs N, Pollock C, Greasley PJ, Andersson EM, Hammarstedt A, Karlsson C, Langkilde AM, Wada T, Heerspink HJL. Effects of dapagliflozin and dapagliflozin-saxagliptin on erythropoiesis, iron and inflammation markers in patients with type 2 diabetes and chronic kidney disease: data from the DELIGHT trial. Cardiovasc Diabetol. 2023 Nov 28;22(1):330. doi: 10.1186/s12933-023-02027-8. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Placebo | Drug | type 2 diabetic patients with chronic kidney diseases will recive placebo for 24 weeks |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |