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

Sponsor
The University of Hong Kong
Study ID
NCT07065357
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Metabolic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin (oral) — DRUG
    Participants received Empagliflozin 10 mg orally once daily for six months.
  • Matching placebo — OTHER
    Participants received matching placebo orally once daily for six months.

Study Details

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.

Key Dates

Start date
Aug 13, 2025
Status verified
Jul 2025
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SGLT2 inhibitor
  • Placebo Comparator: Placebo

Primary Outcome Measure

The change in the continuous metabolic syndrome risk score [ Time Frame: From enrolment to the final visit at 6 months ]

Related Studies