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

NCT07065357 | Enrolling By Invitation Phase 3

• 1 other identifier: UW 23-316
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome

Keywords

sodium-glucose cotransporter-2 inhibitor; metabolic syndrome; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• The change in the continuous metabolic syndrome risk score

  From enrolment to the final visit at 6 months

Secondary Outcomes (12)

• Serum level of adiponectin, AFABP, FGF21, lipocalin-2

  From enrolment to the final visit at 6 months

• Body weight

  From enrolment to the final visit at 6 months

• Waist circumference

  From enrolment to the final visit at 6 months

• Sagittal abdominal diameter

  From enrolment to the final visit at 6 months

• Serum triglycerides

  From enrolment to the final visit at 6 months

Study Arms (2)

SGLT2 inhibitor

EXPERIMENTAL

Drug: Empagliflozin (oral)

Placebo

PLACEBO COMPARATOR

Other: Matching placebo

Interventions

Empagliflozin (oral) DRUG

Participants received Empagliflozin 10 mg orally once daily for six months.

SGLT2 inhibitor

Matching placebo OTHER

Participants received matching placebo orally once daily for six months.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Yap-Hang CHAN

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 15, 2025
• Study Start: August 13, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after the publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee established for this purpose.

Locations

HK (1)