Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels

Red Blood Cell 2,3-biphosphoglycerate Levels in Patients Treated With Empagliflozin. A Prospective Cohort Study.

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Prevention; Tissue Oxygenation; Empagliflozin; SGLT2-Inhibitors; Hematocrit Change
• Intervention / Treatment: Drug: Empagliflozin10Mg Tab

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: KONSTANTINOS KITSIOS, MD,MSc,PhD; Phone Number: +306977295744; Email: kitsios_k@yahoo.gr

Study Locations

• Greece
  • Central Macedonia
    • Thessaloniki, Central Macedonia, Greece, 56403
      • Recruiting
      • Papageorgiou General Hospital
      • Contact: KONSTANTINOS KITSIOS, MD,MSc,PhD; Phone Number: +306977295744; Email: kitsios_k@yahoo.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
treatment with empagliflozin 10mg od; empagliflozin 10mg OD	Drug: Empagliflozin10Mg Tab; TB JARDIANCE 10MG; Other Names: JARDIANCE 10MG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml)	Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml)	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Investigators: Principal Investigator: KONSTANTINOS KITSIOS, MD,MSc,PhD, Aristotle University of Thessaloniki 3d Department of Internal Medicine, Papageorgiou General Hospital, Thessaloniki, Greece

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Empagliflozin
• Other Study ID Numbers: Christina Trakatelli

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: concerns about personal data safety

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No