AI-Driven MRF Type 2 Diabetes Integrating DHT IF and Resistance Training to OM and Functional Outcomes

NCT ID: NCT07336459

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-17

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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AI-Guided Multimodal Rehabilitation Program

Group Type EXPERIMENTAL

AI-Guided Multimodal Rehabilitation Program

Intervention Type COMBINATION_PRODUCT

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

Standard Diabetes Care

Group Type ACTIVE_COMPARATOR

Standard Diabetes Care

Intervention Type DIAGNOSTIC_TEST

Usual pharmacological treatment + general lifestyle advice No structured AI, fasting, or exercise protocol

Interventions

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AI-Guided Multimodal Rehabilitation Program

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

Intervention Type COMBINATION_PRODUCT

Standard Diabetes Care

Usual pharmacological treatment + general lifestyle advice No structured AI, fasting, or exercise protocol

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with Type 2 Diabetes (≥1 year)
* HbA1c between 6.5% and 9.0%
* Sedentary or low physical activity levels
* BMI: 25-35 kg/m²
* Able to perform mild-to-moderate exercise

Exclusion Criteria

* any other disability
* not willing
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Superior University

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Naveed Babur

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Superior University CRC

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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PhDRSW/Batch-Fall23/2228

Identifier Type: -

Identifier Source: org_study_id

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