Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels

February 27, 2024 updated by: Christina Trakatelli, Aristotle University Of Thessaloniki

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml)
Time Frame: 12 weeks
Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml)
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean change in Hct (%)
Time Frame: 12 weeks
Mean change in Hct(%)
12 weeks
Hb (mg/dl)
Time Frame: 12 weeks
Mean change in Hb (mg/dl)
12 weeks
RBC (x1000000/μl)
Time Frame: 12 weeks
Mean change in RBC (x1000000/μl)
12 weeks
MCV (fl),
Time Frame: 12 weeks
Mean change in MCV (fl)
12 weeks
HbA1c (%, mmol/mol),
Time Frame: 12 weeks
Mean change inHbA1c (%, mmol/mol)
12 weeks
erythropoietin (mU/ml)
Time Frame: 12 weeks
Mean change in erythropoietin (mU/ml)
12 weeks
eGFR (ml/min/1.73m2),
Time Frame: 12 weeks
Mean change in eGFR (ml/min/1.73m2),
12 weeks
Urine Albumin to Creatinine Ratio (mg/g)
Time Frame: 12 weeks
Mean change in Urine Albumin to Creatinine Ratio (mg/g)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aristotle University Of Thessaloniki

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: KONSTANTINOS KITSIOS, MD,MSc,PhD, Aristotle University of Thessaloniki 3d Department of Internal Medicine, Papageorgiou General Hospital, Thessaloniki, Greece

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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