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

Singapore General Hospital40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

Magnetic mitohormesisDEVICE

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 40-75 years 2. T2DM of at least 6 months duration 3. HbA1c between 7.0% - 10.0% (most recent 3-months prior to enrolment) 4. Body Mass Index (BMI) between 23.0 and 32.5 kg/m2 5. Able to ambulate independently 6. Willing and able to give written informed consent Exclusion Criteria: 1. Presence of any conditions contraindicated for PEMF exposures (e.g. active electronic implants, pregnancy, pacemakers, implantable defibrillators) 2. Medical advice against physical activity 3. Chest pain when performing physical activity 4. Chest pain at rest 5. BP \> 180/90 mmHg 6. Women who are lactating, pregnant or considering pregnancy 7. Cancer not in remission or receiving active cancer treatment 8. Current participation in another clinical trial 9. Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone) 10. Uncontrolled thyroid disease 11. Significant alcohol intake (\> 1 unit per day for women and \> 2 units per day for men) 12. 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) 13. Anticipated surgery or changes in diabetes medications during the study duration 14. History of severe hypoglycaemia in the recent 3 months 15. Have used the MM device in the past 3 months 16. Had a recent surgical procedure in the last 6 months, where muscle activation can interfere with the healing response

Locations (1)

Singapore General Hospital

Singapore, Singapore

RECRUITING

Outcomes

Primary Outcomes

Change in HbA1C

Change in glycemic control

Time frame: 12 weeks

Change in insulin resistance

Change in Homeostatic Model Assessment for Insulin Resistance index

Time frame: 12 weeks

Central Contacts

Aini Vieon Wu

CONTACT

65762810 vieon.wu.aini@sgh.com.sg

Data from ClinicalTrials.gov

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