Impact of empagliflozin on red blood cell levels and tissue oxygenation
Red Blood Cell 2,3-biphosphoglycerate Levels in Patients Treated With Empagliflozin. A Prospective Cohort Study.
This study is testing how the diabetes medication empagliflozin affects red blood cell levels and oxygen supply in people with type 2 diabetes, heart failure, or chronic kidney disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aristotle University Of Thessaloniki Academic / other |
| Locations | 1 site (Thessaloniki, Central Macedonia) |
| Trial ID | NCT06284850 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore how empagliflozin, a medication used for type 2 diabetes, affects levels of 2,3-biphosphoglycerate in red blood cells. The hypothesis is that changes in these levels may influence tissue oxygen supply, potentially contributing to the cardiovascular and renal protective effects associated with SGLT-2 inhibitors. Patients over 18 with specific conditions such as type 2 diabetes, heart failure, or chronic kidney disease will be monitored while initiating treatment with empagliflozin. The study will assess the relationship between the medication and red blood cell biochemistry.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with type 2 diabetes, heart failure, or chronic kidney disease who are starting empagliflozin treatment.
Not a fit: Patients currently on SGLT-2 inhibitors or those with specific hematologic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how empagliflozin improves tissue oxygenation and cardiovascular health in patients with diabetes and related conditions.
How similar studies have performed: While the specific approach of this study may be novel, similar studies have indicated potential benefits of SGLT-2 inhibitors in cardiovascular and renal protection.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Thessaloniki, Central Macedonia
- Papageorgiou General Hospital — Thessaloniki, Central Macedonia, Greece (Recruiting)
Study contacts
- Principal investigator: KONSTANTINOS KITSIOS, MD,MSc,PhD — Aristotle University of Thessaloniki 3d Department of Internal Medicine, Papageorgiou General Hospital, Thessaloniki, Greece
- Study coordinator: KONSTANTINOS KITSIOS, MD,MSc,PhD
- Email: kitsios_k@yahoo.gr
- Phone: +306977295744
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.