NCT05408936

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

June 3, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

1.5 years

First QC Date

June 2, 2022

Last Update Submit

May 12, 2024

Conditions

Keywords

SGLT2 inhibitors, hemoglobin, NTproBNP, ketones

Outcome Measures

Primary Outcomes (3)

  • Hemoglobin

    0-1-3 months

  • Erythropoetin

    0-1-3 months

  • NT-proBNP

    0-1-3 months

Interventions

Patients receive an SGLT2 inhibitor as part of theirn routine care.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • eGFR\<60 ml/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Patras

Pátrai, 26504, Greece

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, urine

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Ketosis

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAcidosisAcid-Base Imbalance

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 7, 2022

Study Start

June 3, 2022

Primary Completion

December 1, 2023

Study Completion

June 1, 2024

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations