SGLT2HgB: SGLT2 Inhibitors and Hemoglobin
Sponsor
University of Patras (Other)
Overall Status
Recruiting
CT.gov ID
NCT05408936
Collaborator
(none)
100
1
3
33.8
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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.
Actual Study Start Date
:
Jun 3, 2022
Anticipated Primary Completion Date
:
Aug 1, 2022
Anticipated Study Completion Date
:
Sep 1, 2022
Outcome Measures
Primary Outcome Measures
- Hemoglobin [0-1 months]
- Erythropoetin [0-1 months]
- NT-proBNP [0-1 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital of Patras | Patras | Greece | 26504 |
Sponsors and Collaborators
- University of Patras
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ioannis Habeos,
Professor,
University of Patras
ClinicalTrials.gov Identifier:
NCT05408936
Other Study ID Numbers:
- 59/15.02.2022
First Posted:
Jun 7, 2022
Last Update Posted:
Jun 7, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Ioannis Habeos,
Professor,
University of Patras
Additional relevant MeSH terms: