Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-01 @ 8:55 AM
Study NCT ID:
NCT06469658
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Management of Type 2 Diabetes Using AI-Guided (GenAIS TM) Dietary Supplementation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2024-06-12', 'studyFirstSubmitQcDate': '2024-06-17', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c levels', 'timeFrame': '180 days'}], 'secondaryOutcomes': [{'measure': 'Percent change in fasting venous blood glucose levels.', 'timeFrame': '180 days'}, {'measure': 'Percent change in high-sensitivity C-reactive protein', 'timeFrame': '180 days'}, {'measure': 'Percent change in cholesterol', 'timeFrame': '180 days'}, {'measure': 'Percent change in HDL-C,', 'timeFrame': '180 days'}, {'measure': 'Percent change in LDL-C', 'timeFrame': '180 days'}, {'measure': 'Percent change in triglycerides', 'timeFrame': '180 days'}, {'measure': 'Percent change in body weight', 'timeFrame': '180 days'}, {'measure': 'Incidence of any adverse effects related to supplements', 'timeFrame': '180 days'}, {'measure': 'Percent change in Body mass index (BMI)', 'timeFrame': '180 days'}, {'measure': 'Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)', 'timeFrame': '180 days'}, {'measure': 'fasting insulin levels change (mU/mL)', 'timeFrame': '180 days'}, {'measure': 'Waist Circumference (cm) change', 'timeFrame': '180 days'}, {'measure': 'microalbuminuria (%) difference', 'timeFrame': '180 days'}, {'measure': 'changes in physical activity levels (hours/week)', 'timeFrame': '180 days'}, {'measure': 'Percentage of participants using antihypertensive medications (%)', 'timeFrame': '180 days'}, {'measure': 'Percentage of participants using antihypertensive medications (%).', 'timeFrame': '180 days'}, {'measure': 'Percentage of participants using lipid-lowering medications (%).', 'timeFrame': '180 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AI-guided dietary supplementation', 'Personalized supplementation', 'HbA1c reduction', 'Genetic and metabolic profiling'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial investigates the effectiveness of AI-guided dietary supplement prescriptions compared to standard physician-guided prescriptions in managing Type 2 diabetes (T2D). The study includes 160 participants with T2D, aged 40-75, who will be randomly assigned to either the control group (standard physician-guided prescriptions) or the AI-guided group (prescriptions determined by GenAIS, an AI system by Triangel Scientific). The primary objective is to compare the reduction in HbA1c levels between the two groups over 6 months. Secondary outcomes include changes in fasting glucose, lipid profiles, body weight, BMI, hsCRP levels, and adherence to the dietary supplement regimen. The AI system integrates genetic, metabolic, and clinical data to provide personalized supplement recommendations, aiming to improve glycemic control and overall metabolic health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 40 and 75 years.\n* Diagnosed with Type 2 diabetes (HbA1c between 7.0% and 10.0%).\n* Stable anti-diabetic medication regimen for at least 3 months prior to the study.\n* Willingness to provide genetic and metabolic data.\n\nExclusion Criteria:\n\n* Type 1 diabetes or other specific types of diabetes.\n* Significant renal, hepatic, or cardiovascular diseases.\n* Use of dietary supplements that affect glucose metabolism within the last 3 months.\n* Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT06469658', 'briefTitle': 'Personalized Management of Type 2 Diabetes Using AI-Guided (GenAIS TM) Dietary Supplementation', 'organization': {'class': 'OTHER', 'fullName': 'S.LAB (SOLOWAYS)'}, 'officialTitle': 'Personalized Management of Type 2 Diabetes Using AI-Guided (GenAIS TM) Dietary Supplementation: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'SW014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'interventionNames': ['Other: The standard practice dietary supplements intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'interventionNames': ['Other: The AI-guided practice dietary supplements group']}], 'interventions': [{'name': 'The standard practice dietary supplements intervention', 'type': 'OTHER', 'description': 'Participants receive supplements prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.', 'armGroupLabels': ['Group 1']}, {'name': 'The AI-guided practice dietary supplements group', 'type': 'OTHER', 'description': 'Participants receive DS prescriptions determined by GenAIS, an AI system which considers genetic data, metabolic profiles, biochemical markers, and patient history.', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630090', 'city': 'Novosibirsk', 'state': 'Novosibisk Region', 'country': 'Russia', 'facility': 'Center of New Medical Technologies', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'S.LAB (SOLOWAYS)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Triangel Scientific', 'class': 'INDUSTRY'}, {'name': 'Center of New Medical Technologies', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}