Clinical Trial Shows Promising Results for Focused Ultrasound Neuromodulation of Diabetes


Key Points

  • Applying focused ultrasound to the liver may improve diabetes symptoms. 
  • A recent Phase I clinical trial enrolled 16 participants with Type 2 diabetes. 
  • The treatment lowered fasting insulin levels and improved insulin resistance scores. 

Investigation of Liver-Targeted Peripheral Focused Ultrasound Stimulation (pFUS) and its Effect on Glucose Homeostasis and Insulin Resistance in Type 2 Diabetes Mellitus: A Proof of Concept, Phase 1 Trial 

Medical illustration of a liver

A new Phase 1 clinical trial conducted by GE Research at ProSciento, Inc. in Chula Vista, CA, reported that applying focused ultrasound to the hepatoportal plexus of the liver had the potential to improve the symptoms of diabetes. 

The open-label, proof-of-concept study enrolled 16 participants with Type 2 diabetes who each received 15 minutes of focused ultrasound applied to the hepatoportoplexus of the liver once daily for three days. The 11 males and 5 females, with a mean age of 61.9 years (5.39 standard deviation), were then followed for two weeks. Results from the 15 participants who completed the trial indicated a trend toward improvements in insulin resistance, and no adverse events were noted. 

To determine the effects of the neuromodulation, the researchers measured and compared fasting glucose, insulin levels, insulin resistance, and glucose metabolism rates before and after the treatment. To determine safety and tolerability, the scientific team recorded and analyzed adverse events, vital signs, electrocardiograms, and laboratory values. 

Importantly, the treatment lowered fasting insulin, which reduced the participants’ insulin resistance scores. 

In the manuscript, which was published in an international journal of medicine called QJM (formerly the Quarterly Journal of Medicine), the authors stated, “Our findings demonstrate that…focused ultrasound represents a promising new treatment modality that could be used as a non-pharmaceutical adjunct or even alternative to current drug treatments in diabetes.”

The equipment used in the trial was GE’s LOGIQ E10 ultrasound system with software installed to enable clinician-controlled, image-targeted pulsed ultrasound stimulation. The treating physician activated the pulsed stimulus with a push-button control after identifying the region of interest with ultrasound imaging. The imaging and pulsed focused ultrasound treatment were both performed using the same curved abdominal transducer. 

“Type 2 diabetes is a major health challenge worldwide,” said Kelsie Timbie, PhD, the Foundation scientific programs manager. “Reversing insulin resistance would dramatically improve patient health.” 

See QJM 

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