Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels

NCT ID: NCT06284850

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-30

Study Completion Date

2025-11-30

Brief Summary

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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

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Conditions

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Hematocrit Change Cardiovascular Prevention Empagliflozin SGLT2-Inhibitors Tissue Oxygenation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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treatment with empagliflozin 10mg od

empagliflozin 10mg OD

Empagliflozin10Mg Tab

Intervention Type DRUG

TB JARDIANCE 10MG

Interventions

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Empagliflozin10Mg Tab

TB JARDIANCE 10MG

Intervention Type DRUG

Other Intervention Names

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JARDIANCE 10MG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Christina Trakatelli

Assistant Professor Of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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KONSTANTINOS KITSIOS, MD,MSc,PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Papageorgiou General Hospital

Thessaloniki, Central Macedonia, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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KONSTANTINOS KITSIOS, MD,MSc,PhD

Role: CONTACT

+306977295744

Facility Contacts

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KONSTANTINOS KITSIOS, MD,MSc,PhD

Role: primary

+306977295744

Other Identifiers

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Christina Trakatelli

Identifier Type: -

Identifier Source: org_study_id

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