Treating the Metabolic Syndrome With a Sodium-glucose Cotransporter-2 Inhibitor

Launched by THE UNIVERSITY OF HONG KONG · Jul 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medicine called empagliflozin can help treat metabolic syndrome, a health condition often found in people who are overweight or obese and have a combination of problems like high blood pressure, abnormal cholesterol levels, and higher blood sugar. Metabolic syndrome increases the risk of developing diabetes and heart disease, and currently, there are no approved medicines specifically for this condition. Empagliflozin is already used to treat diabetes and heart or kidney problems, and it works by helping the body remove extra sugar through urine, which can also lower weight and blood pressure. This study will involve 160 adults with metabolic syndrome to see if empagliflozin can improve their overall health and reduce their risk factors compared to a placebo (a dummy pill).

People eligible for this trial are adults between 18 and 85 years old who have metabolic syndrome based on specific measurements like waist size, blood pressure, cholesterol, and blood sugar levels. They should not have diabetes or be taking diabetes medicines, and their blood pressure should be well controlled if they are on treatment. Participants will be randomly assigned to take either empagliflozin or a placebo, and researchers will monitor changes in weight, waist size, blood pressure, blood sugar, and cholesterol over time. This trial is not yet recruiting, but if successful, it could offer the first approved treatment for metabolic syndrome, helping many people reduce their risk of serious health problems.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female aged over 18 years and younger than 85 years
• • Fulfils the criteria for the metabolic syndrome \[1\] (waist ≥90cm in men or ≥80cm in women plus at least two other components: triglycerides ≥1.7 mmol/L; HDL \<1.03 in men and \<1.29 in women; blood pressure ≥130 mmHg systolic or ≥85 mmHg diastolic or previously diagnosed hypertension; fasting plasma glucose ≥5.6 mmol/L)
• • Willing to take part in the study and give informed consent
• Exclusion Criteria:
• • Taking medications for diabetes, including oral agents, insulin or glucagon-like peptide-1 agonists
• • Fasting plasma glucose ≥7.0 mmol/L or HbA1c ≥6.5% before randomisation
• • Diagnosis of type 1 diabetes
• • Taking medications for hypertension, unless the blood pressure is well controlled with a stable regime
• • Patient who cannot be randomised to placebo because of a strong indication for an SGLT2 inhibitor
• • Contraindications to empagliflozin (GFR \<60 ml/min/1.73m2)
• • History of intolerance or adverse reactions to an SGLT2 medication
• • Co-morbidities that make the subject unsuitable to be a study subject
• • Mental illness that makes the subject unsuitable
• • Cognitive dysfunction
• • Pregnancy
• • Thyroid disease