Pemf Therapy for the Management of Diabetes in Obese Patients

NCT04183543 | Unknown DMC

• 1 other identifier: PROMISE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The Investigators previously developed pulsed electromagnetic field stimulation therapy (PEMF) for the metabolic activation of muscle and adipose tissues. In vitro and in vivo preliminary data from rodents demonstrate that PEMF-t induced changes reminiscent of beneficial exercise adaptations, in response to enhanced metabolic fuel utilisation. These exercise mimetic effects were achieved in the absence of exercise and its associated mechanical stresses as the rodents were sedentary. A human pilot study conducted with this platform demonstrated improved muscle function after only 5 weeks. The PROMISE pilot trial will investigate whether metabolic activation of muscle with a novel, non-invasive technology will further improve metabolic outcomes in overweight/obese patients with early T2DM who are currently given diet and/ or lifestyle interventions.

Conditions

Obesity; Type 2 Diabetes

Keywords

PEMF

Outcome Measures

Primary Outcomes (2)

• Change in baseline HbA1c at 17 weeks.

  HbA1c will be reported in percentage (%).

  17 weeks.

• Change in baseline fasting blood glucose level at 17 weeks.

  Serum glucose will be reported in mmol/L.

  17 weeks.

Secondary Outcomes (9)

• Change in baseline serum triglycerides at 17 weeks.

  Week 17 (in comparison to baseline measurements).

• Change in baseline serum HDL at 17 weeks.

  Week 17 (in comparison to baseline measurements).

• Change in baseline serum LDL at 17 weeks.

  Week 17 (in comparison to baseline measurements).

• Change in baseline serum cholesterol at 17 weeks.

  17 weeks.

• Change in baseline BMI at 17 weeks.

  17 weeks.

Study Arms (2)

Pulsed Electromagnetic Field Therapy

EXPERIMENTAL

Study participants will receive 20 minutes of PEMFs (10 minutes per leg) on a weekly basis for 16 weeks (Week 1-16). Participants would not be aware of treatment/ sham allocation, as the PEMF device is indistinguishable in operational and non-operational modes. A minimum of 5-day and maximum of 9-day interval between each treatment session shall be followed.

Device: Pulsed Electromagnetic Fields

Sham Therapy

SHAM COMPARATOR

Study participants will receive 20 minutes of placebo treatment (10 minutes per leg) on a weekly basis for 16 weeks (Week 1-16). Participants would not be aware of treatment/ sham allocation, as the PEMF device is indistinguishable in operational and non-operational modes. A minimum of 5-day and maximum of 9-day interval between each treatment session shall be followed.

Device: Sham Therapy

Interventions

Pulsed Electromagnetic Fields DEVICE

The PEMF device produces pulsed magnetic fields at flux densities up to 1.5 mT peak.

Pulsed Electromagnetic Field Therapy

Sham Therapy DEVICE

Inactive Pulsed Electromagnetic Field therapy

Sham Therapy

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Patients who are residing in Singapore for the duration of the study
• Ability to fulfill follow-up procedure
• Men and Women aged 30 - 65 years
• T2DM of duration \<10 years (diagnosis based on HbA1c and/or blood glucose)
• HbA1c ≥ 7% at the last routine clinical check, within the last 12 months if on diet alone
• HbA1c ≥ 6.5% if on treatment with oral hypoglycemic agent(s)
• Body Mass Index (BMI) 27.5 - 45 kg/m2
• Waist circumference \< 200 cm (MRI limit)
• Weight \< 200 kg (MRI limit)

You may not qualify if:

• Current insulin use
• \*Current Metformin use
• Recent HbA1c ≥ 12%
• Weight loss \> 5 kg within the last 6 months
• Recent eGFR \<30 mLs/min/1.73 m2
• Substance abuse
• Known cancer
• Myocardial infarction within the last 6 months
• Severe heart failure with New York Heart Association (NYHA) grade ≥ 3
• Current treatment with anti-obesity drug
• Diagnosed eating disorder or purging
• Women who are lactating, pregnant or considering pregnancy
• Patients who have required hospitalisation for depression or are on antipsychotic drugs
• Patients currently participating in another clinical research trial
• Patients with contraindications for MR scanning or venipuncture

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Related Publications (2)

• Parate D, Franco-Obregon A, Frohlich J, Beyer C, Abbas AA, Kamarul T, Hui JHP, Yang Z. Enhancement of mesenchymal stem cell chondrogenesis with short-term low intensity pulsed electromagnetic fields. Sci Rep. 2017 Aug 25;7(1):9421. doi: 10.1038/s41598-017-09892-w.

  PMID: 28842627 BACKGROUND

• Crocetti S, Beyer C, Schade G, Egli M, Frohlich J, Franco-Obregon A. Low intensity and frequency pulsed electromagnetic fields selectively impair breast cancer cell viability. PLoS One. 2013 Sep 11;8(9):e72944. doi: 10.1371/journal.pone.0072944. eCollection 2013.

  PMID: 24039828 BACKGROUND

Related Links

• News article covering MRegen

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Alfredo Franco-Obregon

  National University of Singapore

  PRINCIPAL INVESTIGATOR

• Asim Shabbir

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rina M Selvan

CONTACT

66016143; surrmps@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed study is a single-centre, double-blinded randomised controlled trial. Multivariate matching based on gender, age, race and BMI will be carried out before randomisation of one subject in each pair into control or treatment group (matched pairs design). Participants will be excluded if they do not meet all inclusion criteria and/ or meet at least one exclusion criterion. Participants will be randomised 1:1 to either the standard of care/ placebo group (no exposure to fields) or the treatment group (PEMF exposure). The research personnel who are not directly involved in the patient care will prepare a randomisation table. Study research personnel, physicians, dieticians and physiotherapists will be blinded to the randomisation assignment.

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: December 3, 2019
• Study Start: January 30, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 1, 2022
• Last Updated: September 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)