Treating the Metabolic Syndrome With a Sodium-glucose Cotransporter-2 Inhibitor (TIME-SGLT2)

The University of Hong Kong (HKU)

Status and phase: Invitation-only; Phase 3

Conditions: Metabolic Syndrome

Treatments: Other: Matching placebo; Drug: Empagliflozin (oral)

Study type: Interventional

Funder types: Other

Identifiers

NCT07065357

UW 23-316

Details and patient eligibility

About

The metabolic syndrome occurs in overweight or obese people who also have abnormal lipids, blood pressure and blood glucose. It precedes the development of diabetes and cardiovascular complications. Currently, there are no drugs licensed for the treatment of the metabolic syndrome. Empagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor, originally developed for diabetes but has since been proven to be beneficial in patients with heart and kidney failure. By increasing glucose excretion in the urine, it reduces body weight, body fat and blood pressure. The investigators therefore hypothesize that it may be the ideal drug to reverse the metabolic syndrome. Search of clinical trials registries shows that there are no industry sponsored trials targeting patients with the metabolic syndrome. The investigators propose to conduct a randomised controlled trial to study the effects of empagliflozin on 160 people with the metabolic syndrome, who will be randomised to receive either empagliflozin or placebo. The primary hypothesis is that empagliflozin will reduce the metabolic syndrome risk score, while secondary outcome measures include circulating levels of adipokines (adiponectin, fibroblast growth factor 21, adipocyte fatty acid-binding protein and lipocalin-2), body weight, waist circumference, blood pressure, glucose and lipids. This drug has already been approved for use in diabetes and cardiovascular risk prevention. This study, if positive, would provide evidence for its use in the metabolic syndrome and the treatment for this syndrome for the first time.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups, including a placebo group

SGLT2 inhibitor

Experimental group

Treatment:

Drug: Empagliflozin (oral)

Placebo

Placebo Comparator group

Treatment:

Other: Matching placebo