Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:50 AM
Study NCT ID:
NCT07272460
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D000093763', 'term': 'Intermittent Fasting'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005215', 'term': 'Fasting'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-09-29', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Anthropometric measures', 'timeFrame': '52-weeks', 'description': 'Differences in body weight (kg) between each study arm'}, {'measure': 'Additional measures of beta-cell function', 'timeFrame': '52-weeks', 'description': 'Insulinogenic index/HOMA-IR.'}, {'measure': 'Additional measures of insulin sensitivity', 'timeFrame': '52-weeks', 'description': 'Matsuda Index'}, {'measure': 'Time above glucose target on isCGM', 'timeFrame': '52 weeks', 'description': 'Differences between each study arm in time-above target of 10 mmol/l (%) obtained by isCGM (FreeStyle Libre devices).'}, {'measure': 'Additional anthropometric measures', 'timeFrame': '52 weeks', 'description': 'Differences in waist circumference between the study arms'}], 'primaryOutcomes': [{'measure': 'Differences in baseline-adjusted Insulin-Secretion-Sensitivity Index-2 (ISSI-2) between the study groups.', 'timeFrame': '52-weeks', 'description': 'Baseline-adjusted beta-cell function at 52 weeks, measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2).'}], 'secondaryOutcomes': [{'measure': 'Differences in baseline-adjusted insulin resistance between the study groups', 'timeFrame': '52-weeks', 'description': 'Baseline-adjusted insulin resistance at 52-weeks measured by HOMA-IR'}, {'measure': 'Differences in time in glucose target range between each study group', 'timeFrame': '52-weeks', 'description': 'Time in glucose target range indicates the amount of time (in %) that glucose readings are within the defined target glucose range of 3.9-10.0 mmol/L.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Randomized controlled trial', 'Time-restricted eating', 'Intermittent fasting', 'Type 2 diabetes'], 'conditions': ['Type 2 Diabetes', 'Overweight (BMI > 25)']}, 'descriptionModule': {'briefSummary': 'Time-restricted eating - where no food is consumed over a period of time - has been shown to promote weight loss and improve cardio-metabolic function. In individuals with type 2 diabetes, it is also been shown to improve glucose control. The investigators propose a randomized controlled trial to determine whether time-restricted eating is an effective therapeutic strategy that can preserve pancreatic beta-cell function and improve glycemic control early in participants with type 2 diabetes.', 'detailedDescription': 'In this study, eligible patients with type 2 diabetes will be randomized to either time-restricted eating or standard lifestyle. The hypothesis under study is whether time-restricted eating can improve pancreatic beta-cell function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with previously diagnosed BMI ≥ 25 kg/m2 and type 2 diabetes within preceding 10 years.\n* Age 18 - 75 years inclusive\n* Stable weight over past 12 weeks (less than 5% change in body weight) (self-reported)\n* Diabetes treatment consisting of lifestyle only or metformin, dipeptidyl peptidase-4 (DPP-4) inhibitor, and sodium-glucose co-transporter 2 (SGLT2) inhibitors either as monotherapy or in combination.\n* Ability to read and understand English\n\nExclusion Criteria:\n\n* Current diabetes treatment with insulin, glucagon-like peptide-1 receptor agonists, and/or sulfonylureas.\n* Use of any other pharmacological treatment for weight-loss\n* Previous surgical treatment for weight loss such as gastric bypass or gastric band\n* Any history of eating disorder\n* Currently pregnant or lactating\n* Renal dysfunction as evidenced by estimated glomerular filtration rate \\< 25 ml/min by CKD-EPI Creatinine Equation\n* New York Heart Association class II-IV heart failure\n* Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases \\>2.5X the upper limit of normal\n* Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)\n* Any other factor likely to limit adherence to the study, in the opinion of the investigators\n* Concurrent participation in another research study relevant to diabetes and metabolic health'}, 'identificationModule': {'nctId': 'NCT07272460', 'acronym': 'TEA-TIME', 'briefTitle': 'Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial', 'organization': {'class': 'OTHER', 'fullName': 'Mount Sinai Hospital, Canada'}, 'officialTitle': 'Time Restricted-eating and Metabolic Health in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'REB # 0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Time-restricted eating', 'description': 'Time-restricted eating protocol consisting of time-restricted eating with 18 hours of fasting and 6 hour window of eating (between 2 to 8 PM) every day.', 'interventionNames': ['Behavioral: Time-restricted eating']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard lifestyle', 'description': 'Standard lifestyle recommendation as per Diabetes Canada Guidelines.', 'interventionNames': ['Behavioral: Standard lifestyle']}], 'interventions': [{'name': 'Time-restricted eating', 'type': 'BEHAVIORAL', 'description': '18 hours of fasting and 6 hour window of eating (between 2 to 8 PM) every day for 52 weeks.', 'armGroupLabels': ['Time-restricted eating']}, {'name': 'Standard lifestyle', 'type': 'BEHAVIORAL', 'description': 'standard lifestyle recommendations as per Diabetes Canada guidelines \\[where patients are encouraged to maintain regularity in timing and spacing of meals with no specific recommendation regarding hours of fasting\\]', 'armGroupLabels': ['Standard lifestyle']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T3L9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Kramer', 'role': 'CONTACT', 'email': 'Caroline.Kramer@sinaihealth.ca', 'phone': '+1416-586-4800', 'phoneExt': '7628'}], 'facility': 'Leadership Sinai Centre for Diabetes', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Caroline K Kramer, MD, PhD', 'role': 'CONTACT', 'email': 'Caroline.Kramer@sinaihealth.ca', 'phone': '+1-416-586-4800', 'phoneExt': '7628'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mount Sinai Hospital, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}