NCT05881200

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

10 months

First QC Date

April 20, 2023

Last Update Submit

June 26, 2023

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes MellitusExerciseInsulin resistanceMagnetic mitohormesis

Outcome Measures

Primary Outcomes (2)

  • Change in HbA1C

    Change in glycemic control

    12 weeks

  • Change in insulin resistance

    Change in Homeostatic Model Assessment for Insulin Resistance index

    12 weeks

Study Arms (1)

Magnetic mitohormesis

EXPERIMENTAL

Treatment using the BIXEPS machine

Device: Magnetic mitohormesis

Interventions

Magnetic mitohormesisDEVICE

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

Magnetic mitohormesis

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169856, Singapore

RECRUITING

Related Publications (2)

  • 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.

    PMID: 26880337BACKGROUND

  • 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.

    PMID: 21115758BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusMotor ActivityInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorHyperinsulinism

Study Officials

  • Hong Chang Tan

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aini Vieon Wu

CONTACT

65762810vieon.wu.aini@sgh.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2023

First Posted

May 31, 2023

Study Start

June 1, 2023

Primary Completion

March 31, 2024

Study Completion

September 30, 2024

Last Updated

June 28, 2023

Record last verified: 2023-06

Locations

SG(1)