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

NCT07186153 | Not Yet Recruiting FDA Drug

• 1 other identifier: Effect of SGLT2 on LAS
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

SGLT 2 Inhibitors

Keywords

left atrial remodelling

Outcome Measures

Primary Outcomes (1)

• follow-up and evaluation of LA remodeling in patients with type-2 diabetes mellitus ( T2DM) before and after treatment with SGLT2 inhibitors

  The study aims evaluation and follow-up of Left Atrial Strain Parameters assessed by Speckle-Tracking Echocardiography (STE) before and after treatment with SGLT2 inhibitors in patients with type-2 diabetes mellitus at Baseline and 6 months follow-up . Left atrial strain will be measured using 2D speckle-tracking echocardiography, including reservoir strain (%), conduit strain (%), and contraction strain (%)

  6 months follow-up

Interventions

Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor DRUG

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

Also known as: Empagliflozin, Dapagliflozin

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 40-75 years with a diagnosis of T2DM on stable antidiabetic therapy not including SGLT2 inhibitors

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• 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.

  PMID: 32802621 BACKGROUND

• 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.

  PMID: 33687616 BACKGROUND

• 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.

  PMID: 28716801 BACKGROUND

• 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.

  PMID: 19808395 BACKGROUND

• 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.

  PMID: 32519220 BACKGROUND

• 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.

  PMID: 31646113 BACKGROUND

MeSH Terms

Interventions

empagliflozin; dapagliflozin

Central Study Contacts

Abanoub Fayoumy Shawky, Bachelor

CONTACT

+201207937601; abanoubfayoumy97@gmail.com

Study Design

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

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: September 22, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09