Magnetic Mitohormesis: Effect of Magnetic Signals on Metabolic Adaptions in Type 2 Diabetes (MENSA-T2D) (MENSA-T2D)
Magnetic Mitohormesis: Effect of Magnetic Signals on Metabolic Adaptions in Type 2 Diabetes
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aini Vieon Wu
- Phone Number: 65762810
- Email: vieon.wu.aini@sgh.com.sg
Study Locations
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-
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Singapore, Singapore, 169856
- Recruiting
- Singapore General Hospital
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Contact:
- Vieon Wu
- Phone Number: +65-63214658
- Email: vieon.wu.aini@sgh.com.sg
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Contact:
- Hong Chang Tan, MBBS, MMed
- Phone Number: +65-63214658
- Email: tan.hong.chang@sgh.com.sg
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Principal Investigator:
- Hong Chang Tan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Magnetic mitohormesis
Treatment using the BIXEPS machine
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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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in HbA1C
Time Frame: 12 weeks
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Change in glycemic control
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12 weeks
|
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Change in insulin resistance
Time Frame: 12 weeks
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Change in Homeostatic Model Assessment for Insulin Resistance index
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hong Chang Tan, Singapore General Hospital
Publications and helpful links
General Publications
- Colberg SR, Sigal RJ, Fernhall B, Regensteiner JG, Blissmer BJ, Rubin RR, Chasan-Taber L, Albright AL, Braun B; American College of Sports Medicine; American Diabetes Association. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement. Diabetes Care. 2010 Dec;33(12):e147-67. doi: 10.2337/dc10-9990.
- Png ME, Yoong J, Phan TP, Wee HL. Current and future economic burden of diabetes among working-age adults in Asia: conservative estimates for Singapore from 2010-2050. BMC Public Health. 2016 Feb 16;16:153. doi: 10.1186/s12889-016-2827-1. Erratum In: BMC Public Health. 2016;16(1):589.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MENSA-T2D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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