SGLT2 Inhibitors and Effects on Hematopoiesis, Inflammati... | NCT05408936

Studies
SGLT2 Inhibitors and Effects on Hematopoiesis, Inflammation and Metabolic Markers

NCT05408936

Sponsor

University of Patras

Status

Unknown status

Last Update Posted

May 14, 2024Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Diabetes Mellitus, Type 2

Interventions

SGLT2 inhibitor

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 3, 2022Actual

Primary Completion Date

Dec 1, 2023Actual

Completion Date

Jun 1, 2024Estimated

First Submitted Date

Jun 2, 2022

First Submission Date that Met QC Criteria

Jun 2, 2022

First Posted Date

Jun 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2024

Last Update Posted Date

May 14, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SGLT2 inhibitor	Drug	Patients receive an SGLT2 inhibitor as part of theirn routine care.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Patras		Pátrai		26504	Greece

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Data available upon reasonable request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D007662	Ketosis

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077203	Sodium-Glucose Transporter 2 Inhibitors

Ancestor Terms

ID	Term
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D007004	Hypoglycemic Agents

Browse Leaves

Not provided

Browse Branches

Not provided