GE researchers in Niskayuna move ultrasound diabetes therapy to human testing

NISKAYUNA — With promising results achieved in diabetic rats, mice and pigs, General Electric researchers in Niskayuna have begun testing ultrasound waves as a way to prevent or reverse Type 2 diabetes in humans.

Roughly one in 10 Americans is diabetic, federal authorities say. For those who can’t control the potentially damaging condition with lifestyle changes, the ultrasound therapy being tested might offer an alternative to medication or insulin therapy.

GE Research is leading the effort, which is partly funded by the federal government. Partners include Albany Medical College.

This past week the team reported results of the preclinical tests on animals in the journal Nature Biomedical Engineering.

“When you do these once a day for three minutes a day, on the disease model you can prevent or reverse diabetes,” said GE senior biomedical engineer Christopher Puleo. “In three different species, that has been shown.”

And the treatment was effective against both diet-induced and genetically inherited diabetes, he said.

Damian Shin, associate professor in the Albany Medical College Department of Neuroscience and Experimental Therapeutics, recalled an experiment in which a rat with an empty stomach was given a load of glucose and its blood glucose level, predictably enough, spiked higher. Then it got a three-minute ultrasound pulse targeted at the glucose nutrient sensors in its liver, and its blood glucose level plummeted.

“For me, that was astounding,” Shin said.

The stimulation of the sensors in the liver travels through the nerves to the brain’s metabolic control centers, triggering them to respond to the glucose.

“We’re learning how to stimulate them, modulate them to try to dial back in what they should be doing,” Puleo said.

The preclinical studies on animals are complete, as is the first small clinic study on human volunteers. A larger phase of human clinical study is next, then an even larger group of people must be test-treated before the device can go before federal regulators to be approved for therapeutic use.

There’s one approval track for drugs and another for devices, Puleo said, both of them years-long. This testing will follow a hybrid track, as it’s a device that would replace drugs or be used in conjunction with drugs. 

GE has been developing noninvasive nerve pathway ultrasound stimulation techniques for six years. This specific project is supported by the federal Defense Advanced Research Projects Agency, which is interested in the technique’s potential use in treating trauma patients.

Also working on the research for GE are Victoria Cotero, who was the lead author of the newly published study on the preclinical tests, and Jeffrey Ashe, the senior electrical engineer on the project.

Joining GE are Albany Medical College, The Feinstein Institutes for Medical Research, UCLA Samueli School of Engineering and Yale School of Medicine, each contributing a particular area of knowledge to the research.

Shin’s lab at Albany Medical College, with its expertise in electrophysiology, recorded the actual nerve firing rate from liver to brain during the tests, Puleo said.

“The GE team needed more definitive evidence that the stimulation of the liver was the direct cause of the effects being recorded,” Shin said. “So my team took on that task.”

He called the theory provocative and the results exciting.

“The data so far is early-stage, but if it does bear out … I think ultrasound neuromodulation is going to be an exciting research and treatment [tool] in the future,” Shin said. And there could be other applications for either metabolic or inflammatory conditions, he added.

Shin points out another hurdle to overcome: Any such device would have to be user-friendly, something the patient could use at home. 

About 37 million Americans have diabetes, according to the Centers for Disease Control. The great bulk of these cases are Type 2 diabetes, in which the body can manufacture insulin but doesn’t do it well, and they are the potential audience for the ultrasound therapy. 

Technology already exists that would allow ultrasound devices to be operable at home alone by the average person, Puleo said. It just needs to be developed further.

“The key aspect here is precision,” Puleo said. “We’re putting pulses exactly where they need to be.”

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