Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrial Remodeling in Diabetic Patients

NCT ID: NCT07186153

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-11-01

Brief Summary

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To evaluate and follow-up left atrial volume, diastolic function by 2D echocardiography and left atrial strain parameters using speckle-tracking echocardiography in patients with type 2 diabetes mellitus (T2DM) before and after treatment with SGLT2 inhibitors

Detailed Description

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Diabetes mellitus (DM) is a chronic metabolic disorder that significantly increases cardiovascular morbidity and mortality. Among the earliest manifestations of diabetic heart disease is subclinical cardiac dysfunction, which includes left atrial (LA) remodeling and impaired LA function.

LA remodeling encompasses changes in atrial size, geometry, wall stress, and mechanical function, and serves as an early marker of diastolic dysfunction and elevated left ventricular (LV) filling pressures.

These changes are key contributors to the development of heart failure, particularly heart failure with preserved ejection fraction (HFpEF)\[4\]and is closely associated with an increased risk of atrial fibrillation (AF).

Conventional echocardiographic parameters often fail to detect early LA dysfunction. Recent advances have highlighted left atrial strain-measured via speckle tracking echocardiography (STE)-as a more sensitive and early marker of LA dysfunction . LA strain assessment, especially during the reservoir, conduit, and contraction phases, provides insights into atrial compliance, stiffness, and overall diastolic function, often preceding structural alterations.

Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors are a class of antihyperglycemic agents that have demonstrated significant cardiovascular benefits in clinical trials. Beyond glycemic control, these agents have been linked to favorable cardiac remodeling, improved diastolic function, and reduced filling pressures. However, their impact on LA function, particularly as assessed by strain parameters, remains underexplored

Conditions

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SGLT 2 Inhibitors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor

evaluate and follow-up left atrial volume, diastolic function by 2D echocardiography and left atrial strain parameters using speckle-tracking echocardiography in patients with type 2 diabetes mellitus (T2DM) after treatment with SGLT2 inhibitors

Intervention Type DRUG

Other Intervention Names

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Empagliflozin Dapagliflozin

Eligibility Criteria

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Inclusion Criteria

* Diagnosed T2DM on antidiabetic medication not including SGLT2 inhibitors.
* HbA1c ≤ 7%.
* Age 40-75 years.
* Sinus rhythm.
* Informed consent obtained

Exclusion Criteria

* History of atrial fibrillation or flutter.
* Patients treated with SGLT2 inhibitors.
* Severe mitral valve regurgitation or stenosis.
* Previous myocardial infarction.
* Previous percutaneous coronary intervention(PCI) or coronary artery bypass grafting (CABG).
* LV Ejection fraction \<50% .
* Severe renal impairment (eGFR \< 30 mL/min/1.73 m²)
* Uncontrolled hypertension (BP \> 160/100 mmHg)
* Inadequate echocardiographic windows or incomplete data
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Abanoub Fayoumy Shawky

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Abanoub Fayoumy Shawky, Bachelor

Role: CONTACT

+201207937601

References

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Rehman SU, Rahman F. Evidence-Based Clinical Review on Cardiovascular Benefits of SGLT2 (Sodium-Glucose Co-Transporter Type 2) Inhibitors in Type 2 Diabetes Mellitus. Cureus. 2020 Aug 11;12(8):e9655. doi: 10.7759/cureus.9655.

Reference Type BACKGROUND
PMID: 32802621 (View on PubMed)

Yuda S. Current clinical applications of speckle tracking echocardiography for assessment of left atrial function. J Echocardiogr. 2021 Sep;19(3):129-140. doi: 10.1007/s12574-021-00519-8. Epub 2021 Mar 9.

Reference Type BACKGROUND
PMID: 33687616 (View on PubMed)

Swoboda PP, McDiarmid AK, Erhayiem B, Ripley DP, Dobson LE, Garg P, Musa TA, Witte KK, Kearney MT, Barth JH, Ajjan R, Greenwood JP, Plein S. Diabetes Mellitus, Microalbuminuria, and Subclinical Cardiac Disease: Identification and Monitoring of Individuals at Risk of Heart Failure. J Am Heart Assoc. 2017 Jul 17;6(7):e005539. doi: 10.1161/JAHA.117.005539.

Reference Type BACKGROUND
PMID: 28716801 (View on PubMed)

Nattel S, Burstein B, Dobrev D. Atrial remodeling and atrial fibrillation: mechanisms and implications. Circ Arrhythm Electrophysiol. 2008 Apr;1(1):62-73. doi: 10.1161/CIRCEP.107.754564. No abstract available.

Reference Type BACKGROUND
PMID: 19808395 (View on PubMed)

Tadic M, Cuspidi C. Left atrial function in diabetes: does it help? Acta Diabetol. 2021 Feb;58(2):131-137. doi: 10.1007/s00592-020-01557-x. Epub 2020 Jun 9.

Reference Type BACKGROUND
PMID: 32519220 (View on PubMed)

Fan W. Epidemiology in diabetes mellitus and cardiovascular disease. Cardiovasc Endocrinol. 2017 Feb 15;6(1):8-16. doi: 10.1097/XCE.0000000000000116. eCollection 2017 Mar.

Reference Type BACKGROUND
PMID: 31646113 (View on PubMed)

Other Identifiers

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Effect of SGLT2 on LAS

Identifier Type: -

Identifier Source: org_study_id

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