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Investigating the effect of Empagliflozin on global longitudinal strain (GLS) and cardiometabolic risk factors in overweight adults

Investigating the effect of Empagliflozin on global longitudinal strain (GLS) and cardiometabolic risk factors in overweight adults

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250311065033N1
Enrollment
64
Registered
2025-04-16
Start date
2025-06-05
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To investigate the effect of empagliflozin on global longitudinal strain (GLS) and cardiometabolic risk factors including mean lipid profile, hemoglobin A1c, systolic blood pressure, diastolic blood pressure, and body fat index in overweight individuals.. Overweight and obesity

Interventions

Intervention 1: Intervention group: In this double-blind clinical trial, overweight adults with GLS lower than -19.9 (age 18 to 70 years) will be enrolled based on the inclusion and absence of exclusi

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Having informed consent and being willing to participate in the study Adults between the ages of 18 and 70 Overweight individuals (BMI <30<24.9) People with GLS <19.9%

Exclusion criteria

Exclusion criteria: Current or previous use (up to 3 months ago) of weight loss medications, probiotic and prebiotic supplements, diabetes, cardiovascular, vitamin and mineral supplements, and other nutritional supplements Suffering from autoimmune diseases, cancer, diabetes, cardiovascular diseases, kidney or liver disorders Pregnancy and breastfeeding or planning to become pregnant within the next 6 months People on a diet or under special exercise programs Suffering from digestive diseases such as chronic inflammatory diseases and irritable bowel syndrome Smoking and alcohol consumption

Design outcomes

Primary

MeasureTime frame
The primary outcome in this study is to examine changes (improvements) in GLS. Timepoint: At the beginning and end of the study, GLS levels (by a cardiologist using echocardiography), biochemical indices, anthropometric indices, blood pressure, physical activity levels, and dietary intakes are assessed. Method of measurement: GLS is assessed automatically by speckle-tracking echocardiography (STE). This method is operator-independent and is more repeatable and easier to measure than EF 1 (7). GLS < -19.9% ??is considered low GLS.

Secondary

MeasureTime frame
Lipid profile. Timepoint: Before the intervention and at the end of the study (three months after taking the drug). Method of measurement: Measurement of triglyceride and total cholesterol concentrations, LDL-C cholesterol, and cholesterol is performed using a kit and enzymatic colorimetric and photometric methods.;Improvement in average hemoglobin A1C. Timepoint: Before the intervention and at the end of the study (three months after taking the drug). Method of measurement: Hemoglobin A1C is measured using a kit and enzymatic colorimetric and photometric methods.;Systolic and diastolic blood pressure. Timepoint: Before the intervention and at the end of the study (three months after taking the drug). Method of measurement: Using a desktop mercury sphygmomanometer.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAisa Ghazliyar

Shahid Beheshti University of Medical Sciences

aisa.ghazeliyar@gmail.com0173430000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026