Clinical trial NCT05881200: Magnetic Mitohormesis: Effect of Magnetic Signals on Metabolic Adaptions in Type 2 Diabetes (MENSA-T2D)
Official title: Magnetic Mitohormesis: Effect of Magnetic Signals on Metabolic Adaptions in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus
Exercise
Insulin resistance
Magnetic mitohormesis
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: QuantumTX Pte Ltd
First posted: 2023-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1C
timeFrame: 12 weeks
measure: Change in insulin resistance
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Hong Chang Tan
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.