Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels

NCT06284850 | Recruiting

• 1 other identifier: Christina Trakatelli
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematocrit Change; Cardiovascular Prevention; Empagliflozin; SGLT2-Inhibitors; Tissue Oxygenation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Mean change in Hct (%)

  12 weeks

• Hb (mg/dl)

  12 weeks

• RBC (x1000000/μl)

  12 weeks

• MCV (fl),

  12 weeks

• HbA1c (%, mmol/mol),

  12 weeks

Study Arms (1)

treatment with empagliflozin 10mg od

empagliflozin 10mg OD

Drug: Empagliflozin10Mg Tab

Interventions

Empagliflozin10Mg Tab DRUG

TB JARDIANCE 10MG

Also known as: JARDIANCE 10MG

treatment with empagliflozin 10mg od

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Papageorgiou General Hospital

Thessaloniki, Central Macedonia, 56403, Greece

RECRUITING

MeSH Terms

Interventions

empagliflozin

Study Officials

• KONSTANTINOS KITSIOS, MD,MSc,PhD

  Aristotle University of Thessaloniki 3d Department of Internal Medicine, Papageorgiou General Hospital, Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KONSTANTINOS KITSIOS, MD,MSc,PhD

CONTACT

+306977295744; kitsios_k@yahoo.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Of Internal Medicine

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: February 29, 2024
• Study Start: November 30, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

GR (1)