Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-31 @ 7:41 AM
Study NCT ID:
NCT07065357
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-24
First Post:
2025-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treating the Metabolic Syndrome With a Sodium-glucose Cotransporter-2 Inhibitor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2025-07-03', 'studyFirstSubmitQcDate': '2025-07-03', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in the continuous metabolic syndrome risk score', 'timeFrame': 'From enrolment to the final visit at 6 months'}], 'secondaryOutcomes': [{'measure': 'Serum level of adiponectin, AFABP, FGF21, lipocalin-2', 'timeFrame': 'From enrolment to the final visit at 6 months'}, {'measure': 'Body weight', 'timeFrame': 'From enrolment to the final visit at 6 months'}, {'measure': 'Waist circumference', 'timeFrame': 'From enrolment to the final visit at 6 months'}, {'measure': 'Sagittal abdominal diameter', 'timeFrame': 'From enrolment to the final visit at 6 months'}, {'measure': 'Serum triglycerides', 'timeFrame': 'From enrolment to the final visit at 6 months'}, {'measure': 'Serum HDL', 'timeFrame': 'From enrolment to the final visit at 6 months'}, {'measure': 'Fasting glucose', 'timeFrame': 'From enrolment to the final visit at 6 months'}, {'measure': 'HbA1c', 'timeFrame': 'From enrolment to the final visit at 6 months'}, {'measure': 'HOMA2-IR', 'timeFrame': 'From enrolment to the final visit at 6 months'}, {'measure': 'HOMA2-B', 'timeFrame': 'From enrolment to the final visit at 6 months'}, {'measure': 'Systolic and diastolic blood pressure', 'timeFrame': 'From enrolment to the final visit at 6 months'}, {'measure': 'The number of abnormal components of the metabolic syndrome in the subject', 'timeFrame': 'From enrolment to the final visit at 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sodium-glucose cotransporter-2 inhibitor', 'metabolic syndrome', 'randomized controlled trial'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged over 18 years and younger than 85 years\n* 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)\n* Willing to take part in the study and give informed consent\n\nExclusion Criteria:\n\n* Taking medications for diabetes, including oral agents, insulin or glucagon-like peptide-1 agonists\n* Fasting plasma glucose ≥7.0 mmol/L or HbA1c ≥6.5% before randomisation\n* Diagnosis of type 1 diabetes\n* Taking medications for hypertension, unless the blood pressure is well controlled with a stable regime\n* Patient who cannot be randomised to placebo because of a strong indication for an SGLT2 inhibitor\n* Contraindications to empagliflozin (GFR \\<60 ml/min/1.73m2)\n* History of intolerance or adverse reactions to an SGLT2 medication\n* Co-morbidities that make the subject unsuitable to be a study subject\n* Mental illness that makes the subject unsuitable\n* Cognitive dysfunction\n* Pregnancy\n* Thyroid disease'}, 'identificationModule': {'nctId': 'NCT07065357', 'acronym': 'TIME-SGLT2', 'briefTitle': 'Treating the Metabolic Syndrome With a Sodium-glucose Cotransporter-2 Inhibitor', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Treating the Metabolic Syndrome With a Sodium-glucose Cotransporter-2 Inhibitor: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'UW 23-316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SGLT2 inhibitor', 'interventionNames': ['Drug: Empagliflozin (oral)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Matching placebo']}], 'interventions': [{'name': 'Empagliflozin (oral)', 'type': 'DRUG', 'description': 'Participants received Empagliflozin 10 mg orally once daily for six months.', 'armGroupLabels': ['SGLT2 inhibitor']}, {'name': 'Matching placebo', 'type': 'OTHER', 'description': 'Participants received matching placebo orally once daily for six months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Yap-Hang CHAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'after the publication.', 'ipdSharing': 'YES', 'description': 'The de-identified individual participant data that underlie the results reported in this publication.', 'accessCriteria': 'Investigators whose proposed use of the data has been approved by an independent review committee established for this purpose.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'CHAN Yap Hang', 'investigatorAffiliation': 'The University of Hong Kong'}}}}