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

January 12, 2026 updated by: Muhammad Naveed Babur, Superior University

AI-Driven Multimodal Rehabilitation Framework for Type 2 Diabetes Integrating Digital Health Technologies, Intermittent Fasting, and Resistance Training to Optimize Metabolic and Functional Outcomes

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan
        • Superior University CRC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI-Guided Multimodal Rehabilitation Program
Combination product: 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
Active Comparator: Standard Diabetes Care
Diagnostic test: Standard Diabetes Care
Usual pharmacological treatment + general lifestyle advice No structured AI, fasting, or exercise protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c (Biochemical Outcome)
Time Frame: 24 Months
HbA1c will be assessed from venous blood and reported as a percentage (%).
24 Months
HOMA-IR (Biochemical Outcome)
Time Frame: 24 Months
HOMA-IR will be derived from fasting glucose and fasting insulin measurements and presented as a unitless index.
24 Months
6-Minute Walk Test (Functional capacity; distance in meters)
Time Frame: 24 Months
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,
24 Months
WHOQOL-BREF
Time Frame: 24 Months
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
24 Months
Diabetes Self-Management Questionnaire
Time Frame: 24 Months
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.
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Superior University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PhDRSW/Batch-Fall23/2228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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