SGLT 2 InhibitorsNCT07186153
Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrial Remodeling in Diabetic Patients
An observational study of SGLT 2 Inhibitors, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- SGLT 2 Inhibitors
- What is being tested?
- Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Adult, Older adult
Study population: Adults aged 40-75 years with a diagnosis of T2DM on stable antidiabetic therapy not including SGLT2 inhibitors
Who may be able to join
- Diagnosed T2DM on antidiabetic medication not including SGLT2 inhibitors.
- HbA1c ≤ 7%.
- Age 40-75 years.
- Sinus rhythm.
- Informed consent obtained
Who cannot join
- 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% .
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- Severe renal impairment (eGFR < 30 mL/min/1.73 m²)
- Uncontrolled hypertension (BP > 160/100 mmHg)
- Inadequate echocardiographic windows or incomplete data
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
Read the detailed description
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
- SGLT 2 Inhibitors
- Being tested
- Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor
- Keywords
- left atrial remodelling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Glucose Co-transporter 2 (SGLT2) InhibitorDrug
Also called Empagliflozin, Dapagliflozin
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SGLT 2 InhibitorsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abanoub Fayoumy Shawky, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186153
- Sponsor's protocol ID
- Effect of SGLT2 on LAS
- Status last verified
- Sep 2025
- First submitted
- 14 Aug 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 32802621Yuda 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.
PubMed 33687616Swoboda 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.
PubMed 28716801Nattel 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.
PubMed 19808395Tadic 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.
PubMed 32519220Fan 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.
PubMed 31646113
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrial Remodeling in Diabetic Patients
- ClinicalTrials.gov ID
- NCT07186153
- Acronym / sponsor ID
- Effect of SGLT2 on LAS
- Conditions
- SGLT 2 Inhibitors
- Keywords
- left atrial remodelling
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults aged 40-75 years with a diagnosis of T2DM on stable antidiabetic therapy not including SGLT2 inhibitors
Key inclusion criteria (5 listed)
- Diagnosed T2DM on antidiabetic medication not including SGLT2 inhibitors.
- HbA1c ≤ 7%.
- Age 40-75 years.
- Sinus rhythm.
- Informed consent obtained
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Glucose Co-transporter 2 (SGLT2) InhibitorAlso: Empagliflozin, Dapagliflozinevaluate 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 | Drug | – |
Primary outcome
follow-up and evaluation of LA remodeling in patients with type-2 diabetes mellitus ( T2DM) before and after treatment with SGLT2 inhibitors
Time frame: 6 months follow-up
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 (%)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Background: PubMed 32802621Rehman 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.
- Background: PubMed 33687616Yuda 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.
- Background: PubMed 28716801Swoboda 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.
- Background: PubMed 19808395Nattel 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.
- Background: PubMed 32519220Tadic 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.
- Background: PubMed 31646113Fan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of SGLT 2 Inhibitors, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abanoub Fayoumy Shawky, Bachelor (+201207937601, abanoubfayoumy97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
follow-up and evaluation of LA remodeling in patients with type-2 diabetes mellitus ( T2DM) before and after treatment with SGLT2 inhibitors (time frame: 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07186153, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.