The modern lifestyle has led to the development and propagation of obesity and type 2
diabetes (T2DM) pandemics. Obesity is associated with increased morbidity and mortality due
to its associated diseases such as T2DM; certain cancers; cardiovascular diseases including
hypertension, coronary artery disease and stroke; as well as mental disorders. T2DM is
currently the main contributor to growing healthcare costs of obesity. One in three
Singaporeans is at risk of developing T2DM, and by 2050, this is estimated to cost Singapore
about $1.8 billion in medical expenses and productivity lost. With a global population trend
towards increased obesity, the prevalence of T2DM will also be increased, thus creating
burgeoning health and socioeconomic consequences. An effective interventional strategy
against these chronic diseases would not only positively impact human health, but also
relieve growing socioeconomic burden.
All guidelines recommend hypocaloric diet and lifestyle interventions (e.g. exercise) to
manage T2DM in overweight or obese patients. The goal is to achieve and maintain 5-10%, and
15-20% weight loss in patients with BMI 25-35 kg/m2 and BMI>35 kg/m2, respectively. This goal
requires limitation of daily calorie intake to 800-1200 and up to 275 minutes of exercise per
week for a moderately obese person. Anti-obesity drugs can also be prescribed for T2DM
patients with BMI > 27 kg/m2. When glycaemic control is not achieved, different progressive
stages of T2DM are managed by monotherapy, dual therapy and finally triple therapy of Glucose
Lowering Drugs (GLDs) without or with insulin program. Invasive bariatric surgeries are also
recommended for T2DM patients with BMI >35 kg/m2 (32.5 kg/m2 in Asian populations), as well
as lower BMI of 30 - 35 kg/m2 (equivalent to 27.5 - 32.5 kg/m2 in Asian populations) when the
metabolic response to regular treatment plans has been poor.
Patient compliance with diet and lifestyle intervention regime can often be challenging, and
yet those who faithfully comply may still fail to achieve the necessary weight loss within a
limited time-frame. Pharmacotherapy with GLDs also carries some risks for side effects such
as hypoglycaemia, weight gain, gastrointestinal problems, infections, bone fracture,
pancreatitis, etc. The most effective approach for long term weight loss of >15% and T2DM
remission has been bariatric surgery. Hypertension remission rates and metabolic control are
also higher with bariatric surgery versus medical treatment. However, surgically treated
patients also had significantly higher risk for additional surgical procedures and other
complications including abdominal pain, gastroduodenal ulcers, long-term nutrition and
micronutrient deficiency, etc. There is a global urgency for patient-friendly yet effective
treatment options with minimal side effects for obesity and T2DM.
T2DM remission in bariatric surgery patients has been intricately linked to weight loss.
Perhaps most intriguing is the observation that glycaemic control is re-established prior to
weight loss and improvement in muscle insulin sensitivity, thus suggesting that there is an
earlier mechanistic juncture, potentially amenable to interventional regulation. In the Twin
Cycle Hypothesis, fat accumulation in the liver and secondarily in the pancreas, leads to
vicious cycles that result in the development of T2DM. Decreasing liver fat content may
potentially be the tunable interventional juncture in promoting remission of T2DM in
overweight and obese patients. 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 (DL) interventions.
Better glycaemic control at the early stages of T2DM would
improve the management of this progressive disease,
reduce reliance on multi-GLDs therapy, and
potentially reduce reliance on bariatric surgeries solely for treatment of T2DM.
The Investigators of this study 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. This study will
investigate the use of PEMFs as a non-invasive modality to supplement current clinical
standards in enhancing rehabilitation management and improving metabolic outcomes in this
clinical base.