Clinical trial NCT06284850: Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels
Official title: Red Blood Cell 2,3-biphosphoglycerate Levels in Patients Treated With Empagliflozin. A Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematocrit Change
Cardiovascular Prevention
Empagliflozin
SGLT2-Inhibitors
Tissue Oxygenation
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml)
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean change in Hct (%)
timeFrame: 12 weeks
measure: Hb (mg/dl)
timeFrame: 12 weeks
measure: RBC (x1000000/μl)
timeFrame: 12 weeks
measure: MCV (fl),
timeFrame: 12 weeks
measure: HbA1c (%, mmol/mol),
timeFrame: 12 weeks
measure: erythropoietin (mU/ml)
timeFrame: 12 weeks
measure: eGFR (ml/min/1.73m2),
timeFrame: 12 weeks
measure: Urine Albumin to Creatinine Ratio (mg/g)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital
state: Central Macedonia
Study officials:
affiliation: Aristotle University of Thessaloniki 3d Department of Internal Medicine, Papageorgiou General Hospital, Thessaloniki, Greece
name: KONSTANTINOS KITSIOS, MD,MSc,PhD
role: PRINCIPAL_INVESTIGATOR
References: