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Enrolling by Invitation

NCT Number: NCT07065357

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

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.

Enrolling by Invitation

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Queen Mary Hospital

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The change in the continuous metabolic syndrome risk score

    Time frame: From enrolment to the final visit at 6 months

Secondary outcomes

  1. Serum level of adiponectin, AFABP, FGF21, lipocalin-2

    Time frame: From enrolment to the final visit at 6 months

  2. Body weight

    Time frame: From enrolment to the final visit at 6 months

  3. Waist circumference

    Time frame: From enrolment to the final visit at 6 months

  4. Sagittal abdominal diameter

    Time frame: From enrolment to the final visit at 6 months

  5. Serum triglycerides

    Time frame: From enrolment to the final visit at 6 months

  6. Serum HDL

    Time frame: From enrolment to the final visit at 6 months

  7. Fasting glucose

    Time frame: From enrolment to the final visit at 6 months

  8. HbA1c

    Time frame: From enrolment to the final visit at 6 months

  9. HOMA2-IR

    Time frame: From enrolment to the final visit at 6 months

  10. HOMA2-B

    Time frame: From enrolment to the final visit at 6 months

  11. Systolic and diastolic blood pressure

    Time frame: From enrolment to the final visit at 6 months

  12. The number of abnormal components of the metabolic syndrome in the subject

    Time frame: From enrolment to the final visit at 6 months

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Treating the Metabolic Syndrome With a Sodium-glucose Cotransporter-2 Inhibitor: a Randomised Controlled Trial

Acronym: TIME-SGLT2

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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