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

Diabetes Mellitus, Type 2 Clinical Trial

— MENSA-T2D  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05881200
• Other study ID #: MENSA-T2D
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2023
• Source: Singapore General Hospital
• Contact: Aini Vieon Wu
• Phone: 65762810
• Email: vieon.wu.aini[@]sgh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• 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

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore General Hospital	QuantumTX Pte Ltd

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1C	Change in glycemic control	12 weeks
Primary	Change in insulin resistance	Change in Homeostatic Model Assessment for Insulin Resistance index	12 weeks