Queen Mary Hospital
Hong Kong
NCT Number: NCT07065357
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Phase 3
Hong Kong
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants received Empagliflozin 10 mg orally once daily for six months.
Participants received matching placebo orally once daily for six months.
Time frame: From enrolment to the final visit at 6 months
Time frame: From enrolment to the final visit at 6 months
Time frame: From enrolment to the final visit at 6 months
Time frame: From enrolment to the final visit at 6 months
Time frame: From enrolment to the final visit at 6 months
Time frame: From enrolment to the final visit at 6 months
Time frame: From enrolment to the final visit at 6 months
Time frame: From enrolment to the final visit at 6 months
Time frame: From enrolment to the final visit at 6 months
Time frame: From enrolment to the final visit at 6 months
Time frame: From enrolment to the final visit at 6 months
Time frame: From enrolment to the final visit at 6 months
Time frame: From enrolment to the final visit at 6 months
The University of Hong Kong
Other
Treating the Metabolic Syndrome With a Sodium-glucose Cotransporter-2 Inhibitor: a Randomised Controlled Trial
Acronym: TIME-SGLT2
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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