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

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Device: Magnetic mitohormesis

• Registration Number: NCT05881200
• Lead Sponsor: Singapore General Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2023-04-20
• Study First Submitted QC: 2023-05-30
• Study First Posted: 2023-05-31
• Status Verified: 2023-06
• Study Start: 2023-06-01
• Last Update Submitted: 2023-06-26
• Last Update Posted: 2023-06-28
• Primary Completion: 2024-03-31
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magnetic mitohormesis	Magnetic mitohormesis	Treatment using the BIXEPS machine

Primary Outcome Measures

Name	Time	Method
Change in HbA1C	12 weeks	Change in glycemic control
Change in insulin resistance	12 weeks	Change in Homeostatic Model Assessment for Insulin Resistance index

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore