Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:04 AM
Study NCT ID:
NCT07336459
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-13
First Post:
2025-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AI-Driven MRF Type 2 Diabetes Integrating DHT IF and Resistance Training to OM and Functional Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'C563359', 'term': 'Diabetes Mellitus, Noninsulin-Dependent, 1'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-12', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2026-01-12', 'lastUpdatePostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c (Biochemical Outcome)', 'timeFrame': '24 Months', 'description': 'HbA1c will be assessed from venous blood and reported as a percentage (%).'}, {'measure': 'HOMA-IR (Biochemical Outcome)', 'timeFrame': '24 Months', 'description': 'HOMA-IR will be derived from fasting glucose and fasting insulin measurements and presented as a unitless index.'}, {'measure': '6-Minute Walk Test (Functional capacity; distance in meters)', 'timeFrame': '24 Months', 'description': 'The 6-Minute Walk Test (6MWT) measures functional capacity by recording the total distance (in meters) a person can walk in six minutes on a flat, straight course. Healthy adults typically walk between 400 and 700 meters,'}, {'measure': 'WHOQOL-BREF', 'timeFrame': '24 Months', 'description': "The WHOQOL-BREF is a 26-item, self-report questionnaire developed by the World Health Organization (WHO) for measuring an individual's self-perceived quality of life. It is a widely used and cross-culturally validated abbreviated version of the original, more comprehensive WHOQOL-Score 0-100"}, {'measure': 'Diabetes Self-Management Questionnaire', 'timeFrame': '24 Months', 'description': 'Diabetes Self-Management Questionnaire (DSMQ), first reverse the scores for any negatively worded items so higher scores consistently indicate more effective self-care. Then, sum the scores for all items to get a raw total score. This raw score can be transformed to a scale of 0-10 by dividing the raw score by the theoretical maximum and multiplying by 10 for easier interpretation and comparison.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus 1']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to evaluate the effectiveness of an AI-driven multimodal rehabilitation framework combining digital health technologies, intermittent fasting, and resistance training in individuals with Type 2 Diabetes Mellitus (T2DM). The study will integrate mobile-based AI monitoring for glucose trends, physical activity tracking, and dietary adherence reminders, thereby improving patient engagement and self-management.', 'detailedDescription': 'Participants will be randomized into two groups: the intervention group receiving AI-guided resistance training alongside intermittent fasting, and the control group receiving standard diabetes care. Outcomes will include changes in HbA1c, insulin sensitivity (HOMA-IR), muscle strength, functional mobility, and quality of life. The study will also assess adherence, feasibility, and cost-effectiveness. By utilizing AI-enabled technology and lifestyle-based interventions, this study addresses the gap between clinical management and sustainable self-care in T2DM. The framework is designed to be low-cost, scalable, and adaptable, making it suitable for resource-limited healthcare systems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Type 2 Diabetes (≥1 year)\n* HbA1c between 6.5% and 9.0%\n* Sedentary or low physical activity levels\n* BMI: 25-35 kg/m²\n* Able to perform mild-to-moderate exercise\n\nExclusion Criteria:\n\n* any other disability\n* not willing'}, 'identificationModule': {'nctId': 'NCT07336459', 'briefTitle': 'AI-Driven MRF Type 2 Diabetes Integrating DHT IF and Resistance Training to OM and Functional Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'AI-Driven Multimodal Rehabilitation Framework for Type 2 Diabetes Integrating Digital Health Technologies, Intermittent Fasting, and Resistance Training to Optimize Metabolic and Functional Outcomes', 'orgStudyIdInfo': {'id': 'PhDRSW/Batch-Fall23/2228'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AI-Guided Multimodal Rehabilitation Program', 'interventionNames': ['Combination Product: AI-Guided Multimodal Rehabilitation Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Diabetes Care', 'interventionNames': ['Diagnostic Test: Standard Diabetes Care']}], 'interventions': [{'name': 'AI-Guided Multimodal Rehabilitation Program', 'type': 'COMBINATION_PRODUCT', 'description': 'Digital Health: Mobile AI-based app with glucose tracking, exercise reminders, and fasting compliance monitoring Intermittent Fasting: 16:8 time-restricted feeding protocol, 5 days/week Resistance Training: 3 sessions/week (45 minutes), supervised + home-based program using elastic bands \\& bodyweight', 'armGroupLabels': ['AI-Guided Multimodal Rehabilitation Program']}, {'name': 'Standard Diabetes Care', 'type': 'DIAGNOSTIC_TEST', 'description': 'Usual pharmacological treatment + general lifestyle advice No structured AI, fasting, or exercise protocol', 'armGroupLabels': ['Standard Diabetes Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Superior University CRC', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}