Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels

Recruiting

• Conditions: Cardiovascular Prevention; Hematocrit Change; Empagliflozin; SGLT2-Inhibitors; Tissue Oxygenation
• Interventions: Drug: Empagliflozin10Mg Tab

• Registration Number: NCT06284850
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

The aim of this study is to investigate the hypothesis that treatment with empagliflozin may have an impact on red blood cell 2,3-biphosphoglycerate levels affecting tissue oxygen supply and thus mediating part of the cardio- and reno- protective effect of SGLT-2 inhibitors.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-30
• Study First Submitted: 2024-01-10
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-27
• Last Update Submitted: 2024-02-27
• Study First Posted: 2024-02-29
• Last Update Posted: 2024-02-29
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients>18 year-old and at least one of the following

• Type 2 Diabetes Mellitus and HbA1c: 6.5-9.0% or HbA1c <6.5% and history of Coronary Artery Disease or Stroke not treated with GLP-1RA
• Heart Failure defined as Ejection Fraction<40% or NT-proBNP>300pg/ml or Atrial fibrillation and NT-proBNP>900pg/ml
• Chronic Kidney Disease defined as eGFR<60ml/min/1.73m2 (CKPD- EPI) or/and UACR>200mg/g Initiating treatment with empagliflozin 10mg once daily as add on treatment

Exclusion Criteria

• Patients already treated with an SGLT-2 inhibitor
• Patients with Hb<11gr/dl or>16gr/dl
• Patients with history of inherited or acquired hemoglobin disease
• Patients with history of hemolytic anemia
• Patients with history of hematologic malignancy or myelodysplastic syndrome or myeloproliferative syndrome
• Patients treated within the last 6 months for anemia due to iron, B12 or folate deficiency
• Patients with history of major hemorrhage or major operation leading to RBC transfusion within the last 3 months.
• Patients planning major operation or revascularization procedure within the 12 following weeks
• Patients treated with erythropoietin
• Patients with Chronic Kidney Disease and GFR<30ml/min/1.73m2
• Pregnancy
• Women of childbearing age not receiving appropriate contraception measures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
treatment with empagliflozin 10mg od	Empagliflozin10Mg Tab	empagliflozin 10mg OD

Primary Outcome Measures

Name	Time	Method
Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml)	12 weeks	Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml)

Secondary Outcome Measures

Name	Time	Method
HbA1c (%, mmol/mol),	12 weeks	Mean change inHbA1c (%, mmol/mol)
Hb (mg/dl)	12 weeks	Mean change in Hb (mg/dl)
RBC (x1000000/μl)	12 weeks	Mean change in RBC (x1000000/μl)
eGFR (ml/min/1.73m2),	12 weeks	Mean change in eGFR (ml/min/1.73m2),
erythropoietin (mU/ml)	12 weeks	Mean change in erythropoietin (mU/ml)
Mean change in Hct (%)	12 weeks	Mean change in Hct(%)
MCV (fl),	12 weeks	Mean change in MCV (fl)
Urine Albumin to Creatinine Ratio (mg/g)	12 weeks	Mean change in Urine Albumin to Creatinine Ratio (mg/g)

Trial Locations

Locations (1)

Papageorgiou General Hospital; 🇬🇷 Thessaloniki, Central Macedonia, Greece