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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Application of Magnetic Fields as Adjunctive Treatment for Type II Diabetes

NCT00863954

Type II Diabetes Mellitus

COMPLETED PHASE1

The Application of Extremely Low Level Magnetic Fields as Adjunctive Treatment for Type II Diabetes

NCT00982293

Type 2 Diabetes

TERMINATED PHASE2

Interval Training and Electromagnetic Therapy on Cardiovascular Disease Risk in Diabetic Elderly

NCT06974435

Cardiovascular Disease Risk Reduction Diabetes Lower Extremity Dysfunction

COMPLETED NA

A Trial for the Use of a Pulsed Electromagnetic Field Device to Assist Management of Type 2 Diabetes

NCT04884425

Type 2 Diabetes

UNKNOWN NA

The Effects of the Magnetic Molecular Energizer (MME) on Diabetic Peripheral Neuropathy

NCT00134524

Diabetic Neuropathies Pain Neuralgia

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Magnetic mitohormesis

Treatment using the BIXEPS machine

Group Type EXPERIMENTAL

Magnetic mitohormesis

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Magnetic mitohormesis

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No