Magnetic Mitohormesis: Effect of Magnetic Signals on Metabolic Adaptions in Type 2 Diabetes (MENSA-T2D)

Study Overview
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Brief Summary
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Magnetic Mitohormesis (MM) replicates the metabolic and regenerative effects of exercise using an equipment called the BIXEPS machine, which introduces magnetic fields to the thigh muscles in a non-invasive and painless manner. Since exercise improves the blood glucose control of patients with Type 2 Diabetes Mellitus (T2DM), we believe that MM can provide the same benefits. This single-arm pilot study investigates the effect of MM therapy on glycemic control in individuals with T2DM.

Detailed Description
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Type 2 diabetes mellitus (T2DM) is becoming a significant health issue in the ageing Singapore population. Exercise has been shown to improve peripheral insulin sensitivity, and exercise interventions are often prescribed alongside medication to manage diabetes. However, patient compliance with diet and exercise intervention regimes can often be challenging. Magnetic Mitohormesis (MM) is an alternative method of muscle and mitochondria activation. MM sessions are brief 10-minute weekly sessions that recreate similar biological and metabolic adaptations as exercise but without physical stress or strain. MM can be easily applied to any age group while seated and without limitations on users' physical aptitude. Having MM as an adjunct therapy to exercise and drug interventions could improve glycaemic control in T2DM patients, especially amongst the ageing population and those with less exercise capacity. This single-arm pilot study investigates the effect of MM therapy on glycemic control in individuals with T2DM.

Official Title
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Magnetic Mitohormesis: Effect of Magnetic Signals on Metabolic Adaptions in Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Magnetic mitohormesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40-75 years T2DM of at least 6 months duration HbA1c between 7.0% - 10.0% (most recent 3-months prior to enrolment) Body Mass Index (BMI) between 23.0 and 32.5 kg/m2 Able to ambulate independently Willing and able to give written informed consent Exclusion Criteria: Presence of any conditions contraindicated for PEMF exposures (e.g. active electronic implants, pregnancy, pacemakers, implantable defibrillators) Medical advice against physical activity Chest pain when performing physical activity Chest pain at rest BP > 180/90 mmHg Women who are lactating, pregnant or considering pregnancy Cancer not in remission or receiving active cancer treatment Current participation in another clinical trial Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone) Uncontrolled thyroid disease Significant alcohol intake (> 1 unit per day for women and > 2 units per day for men) Any factors likely to limit adherence to study protocol (e.g. dementia; alcohol or substance abuse; history of unreliability in medication taking or appointment keeping; significant concerns about participation in the study from spouse, significant other or family members) Anticipated surgery or changes in diabetes medications during the study duration History of severe hypoglycaemia in the recent 3 months Have used the MM device in the past 3 months Had a recent surgical procedure in the last 6 months, where muscle activation can interfere with the healing response

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnetic mitohormesis<br>Treatment using the BIXEPS machine | Device: Magnetic mitohormesis<br>* The BIXEPS machine employs gentle pulsed magnetic signals specifically tuned to activate the natural powerhouse (mitochondria) within muscle. Brief 10-minute MM sessions with the device recreate similar biological and metabolic effects as exercise, but without physical stress or strain. It is intended to improve the strength and function of users, promoting overall fitness and well-being. Just like exercise, these effects accumulate with time. Subjects will receive 12 sessions of 10 minute treatments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1C | Change in glycemic control | 12 weeks | 
| Change in insulin resistance | Change in Homeostatic Model Assessment for Insulin Resistance index | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Exercise, Insulin resistance, Magnetic mitohormesis