Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT07065357
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07065357
Study Brief:
Protocol Section:
NCT07065357