Active, Not Recruiting

NCT Number: NCT07336459

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Type 2 Diabetes Mellitus 1 Diabetes Mellitus, Noninsulin-Dependent, 1

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Superior University CRC

Lahore, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AI-Guided Multimodal Rehabilitation Program

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

Diagnostic Test

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

Primary outcomes

HbA1c (Biochemical Outcome)

Time frame: 24 Months

HbA1c will be assessed from venous blood and reported as a percentage (%).
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.
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,
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
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.

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jan 13, 2026
Registry last updated: Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.