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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Magnetic mitohormesis
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Exercise, Insulin resistance, Magnetic mitohormesis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Singapore General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magnetic mitohormesis

Arm Description

Treatment using the BIXEPS machine

Outcomes

Primary Outcome Measures

Change in HbA1C
Change in glycemic control
Change in insulin resistance
Change in Homeostatic Model Assessment for Insulin Resistance index

Secondary Outcome Measures

Full Information

First Posted
April 20, 2023
Last Updated
June 26, 2023
Sponsor
Singapore General Hospital
Collaborators
QuantumTX Pte Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05881200
Brief Title
Magnetic Mitohormesis: Effect of Magnetic Signals on Metabolic Adaptions in Type 2 Diabetes (MENSA-T2D)
Acronym
MENSA-T2D
Official Title
Magnetic Mitohormesis: Effect of Magnetic Signals on Metabolic Adaptions in Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
QuantumTX Pte Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Exercise, Insulin resistance, Magnetic mitohormesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magnetic mitohormesis
Arm Type
Experimental
Arm Description
Treatment using the BIXEPS machine
Intervention Type
Device
Intervention Name(s)
Magnetic mitohormesis
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in HbA1C
Description
Change in glycemic control
Time Frame
12 weeks
Title
Change in insulin resistance
Description
Change in Homeostatic Model Assessment for Insulin Resistance index
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aini Vieon Wu
Phone
65762810
Email
vieon.wu.aini@sgh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Chang Tan
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169856
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Chang Tan, MBBS, MMed
Phone
+65-63214658
Email
tan.hong.chang@sgh.com.sg
First Name & Middle Initial & Last Name & Degree
Vieon Wu
Phone
+65-63214658
Email
vieon.wu.aini@sgh.com.sg
First Name & Middle Initial & Last Name & Degree
Hong Chang Tan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26880337
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.
Results Reference
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PubMed Identifier
21115758
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.
Results Reference
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Magnetic Mitohormesis: Effect of Magnetic Signals on Metabolic Adaptions in Type 2 Diabetes (MENSA-T2D)

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