SGLT2 Inhibitors and Effects on Hematopoiesis, Inflammation and Metabolic Markers (SGLT2HgB)

May 12, 2024 updated by: Ioannis Habeos, University of Patras

Study of the Mechanisms Leading to Increased Hemoglobin Levels and of the Cardiorenal Response in Type 2 Diabetic Patients With Recent Initiation of SGLT2 Inhibitors.

Study of the response to SGLT2 inhibitors in type 2 diabetic patients with relevance to the erythropoesis and indexes of cardiorenal function.

The study enrolls type 2 diabetic patients in whom the introduction of a SGLT2 inhibitor is deemed necessary as part of their routine treatment during their visit to our outpatient diabetes unit.

A whole blood, a serum and a urine sample is obtained before and one month after the initiation of treatment with a SGLT2 inhibitor.

Study Overview

Status

Active, not recruiting

Conditions

Diabetes Mellitus, Type 2

Intervention / Treatment

Drug: SGLT2 inhibitor

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

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

Study Locations

Greece
- - Patras, Greece, 26504
    - University Hospital of Patras

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

Type 2 diabetic patients who visit the diabetes outpatient clinic in the University Hospital of Patras, Greece

Description

Inclusion Criteria:

type 2 diabetes
Hba1C>7% on their current treatment
introduction of SGLT2 inhibitor as part of their routine care

Exclusion Criteria:

eGFR<60 ml/min

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hemoglobin Time Frame: 0-1-3 months	0-1-3 months
Erythropoetin Time Frame: 0-1-3 months	0-1-3 months
NT-proBNP Time Frame: 0-1-3 months	0-1-3 months

Collaborators and Investigators

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

Sponsor

University of Patras

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)

June 3, 2022

Primary Completion (Actual)

December 1, 2023

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

June 2, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 12, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

SGLT2 inhibitors, hemoglobin, NTproBNP, ketones

Additional Relevant MeSH Terms

Other Study ID Numbers

59/15.02.2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data available upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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.