Effects Dapagliflozin on Inflammatory Markers Erythropoiesis and Iron Metabolism in Patients With Type 2 Diabetes and CKD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dapagliflozin (DAPA), Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Diseases, Diabetes Type 2. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
English Title of Research Project: Effects of Dapagliflozin on Inflammatory Markers, Erythropoiesis and Iron Metabolism in Patients With Type 2 Diabetes and CKD
Overview
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
- Drug Dapagliflozin (DAPA)
patient will recive dapagliflozin for 24 week to improvement of eGFR on CKD patients - Drug Placebo
type 2 diabetic patients with chronic kidney diseases will recive placebo for 24 weeks
Primary outcome measures
- GFR in CKD patients [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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- PMID 38017482
Identifiers
NCT: NCT06820567 · effect Dapagliflozin on CKD