Pemf Therapy for the Management of Diabetes in Obese Patients (PROMISE)
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|ClinicalTrials.gov Identifier: NCT04183543|
Recruitment Status : Recruiting
First Posted : December 3, 2019
Last Update Posted : September 1, 2021
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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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Type 2 Diabetes||Device: Pulsed Electromagnetic Fields Device: Sham Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||PEMF Therapy for the Management of Diabetes in Obese Patients (ProMise): A Randomized Controlled Trial|
|Actual Study Start Date :||January 30, 2020|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||December 2022|
Experimental: Pulsed Electromagnetic Field Therapy
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
The PEMF device produces pulsed magnetic fields at flux densities up to 1.5 mT peak.
Sham Comparator: Sham Therapy
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
Inactive Pulsed Electromagnetic Field therapy
- Change in baseline HbA1c at 17 weeks. [ Time Frame: 17 weeks. ]HbA1c will be reported in percentage (%).
- Change in baseline fasting blood glucose level at 17 weeks. [ Time Frame: 17 weeks. ]Serum glucose will be reported in mmol/L.
- Change in baseline serum triglycerides at 17 weeks. [ Time Frame: Week 17 (in comparison to baseline measurements). ]Reported in mmol/L.
- Change in baseline serum HDL at 17 weeks. [ Time Frame: Week 17 (in comparison to baseline measurements). ]HDL is reported in mmol/L.
- Change in baseline serum LDL at 17 weeks. [ Time Frame: Week 17 (in comparison to baseline measurements). ]LDL is reported in mmol/L.
- Change in baseline serum cholesterol at 17 weeks. [ Time Frame: 17 weeks. ]Cholesterol is reported in mmol/L.
- Change in baseline BMI at 17 weeks. [ Time Frame: 17 weeks. ]Weight and height will be combined to report BMI in kg/m^2.
- Change in baseline body weight at 17 weeks. [ Time Frame: 17 weeks. ]Bodyweight will be measured in kg.
- Change in baseline waist-hip ratio at 17 weeks. [ Time Frame: 17 weeks. ]Waist and hip circumferences will be measured in cm. Ratio will be calculated as waist measurement divided by hip measurement.
- Change in baseline serum C-Peptide at 17 weeks. [ Time Frame: 17 weeks. ]C-Peptide will be reported in ug/L
- Change in baseline blood pressure at 17 weeks. [ Time Frame: 17 weeks. ]BP will be reported in mmHg.
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|Ages Eligible for Study:||21 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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)
- 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
- In the event that 80% recruitment cannot be achieved by the end of 2 months, patients on Metformin will be included and prescribed an alternative drug (such as Dipeptidyl peptidase-4 inhibitors (DPP), GLP1 receptor agonist, Sulfonylureas, Alpha glucosidase inhibitor (AGI), or SGLT2 inhibitors) for at least 4 weeks before the start of the trial.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04183543
|Contact: Rina M Selvanfirstname.lastname@example.org|
|National University Hospital||Recruiting|
|Singapore, Singapore, 119074|
|Contact: Javis Fung 67723441 email@example.com|
|Principal Investigator:||Alfredo Franco-Obregon||National University of Singapore|
|Principal Investigator:||Asim Shabbir||National University Hospital, Singapore|
|Responsible Party:||National University Hospital, Singapore|
|Other Study ID Numbers:||
|First Posted:||December 3, 2019 Key Record Dates|
|Last Update Posted:||September 1, 2021|
|Last Verified:||June 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Glucose Metabolism Disorders
Endocrine System Diseases