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Participants Sought for Study:NH Researchers Seek Volunteers for Diabetes Study

By Adam Drapcho
THE KEENE SENTINEL
New Hampshire researchers are looking for participants in a study this fall on whether a simple procedure could eliminate the need for supplemental insulin in adults with Type 2 diabetes.

The study — taking place nationwide and in Europe, but with a local site at Dartmouth Hitchcock Medical Center in Lebanon — intends to build on the findings in a preliminary study, which suggests a relatively simple outpatient procedure could allow a person with Type 2 to live without injectable insulin.

Adults with Type 2 diabetes currently require supplemental insulin because the chronic condition affects the way their body processes blood sugar. Also known as adult-onset diabetes, the illness is common and increasing, affecting about one in every 11 adults, according to the Centers for Disease Control and Prevention.

Dr. Richard Rothstein, a gastroenterologist and chair of medicine at Dartmouth Hitchcock, is one of the facilitators of the study, which will begin this fall with 420 people enrolled across the participating sites.

Dartmouth Hitchcock is the only New Hampshire hospital participating in the study, and hopes to enroll at least 20 local patients, Rothstein said in an email Friday.

“There are over 40 sites, but as we are the only one in northern New England, we would encourage participation and would be delighted for engagement with this study,” he said. The study has additional sites in Boston and New Haven, Conn., in along with locations throughout the U.S. and Europe.

This study will follow a pilot study performed two years ago in the Netherlands. Sixteen participants underwent an endoscopic procedure, which thinned the wall of the first part of the small intestine, known as the duodenum. This body part plays an important role in responding to the amount of sugar and other nutrients being consumed, according to Rothstein, and therefore in how much insulin the body should release in order to utilize that sugar.

In that study, about half of the participants were able to control their blood sugar without the use of insulin for at least 18 months following the treatment. The procedure itself takes about 20 minutes, with the participant’s experience lasting about one hour, including post-procedure recovery, according to Rothstein. People who received this procedure reported having almost no side effects.

“Years ago, when I heard about this, I thought it was science fiction,” Rothstein said. He was intrigued by the possibility of a treatment, one which carried minimal cost or risk of side effects, that had the potential of controlling blood sugar without the need for supplemental insulin.

Other options to help Type 2 patients reduce their insulin intake are more invasive, Rothstein explained.

For example, patients who had bariatric surgery — an operation that limits stomach capacity and induces weight loss — report better blood sugar levels because of the way it affects the duodenum.

“Patients will have a very improved blood sugar immediately after that surgery,” Rothstein said, “but surgery is very invasive.”

This new study will explore if the same benefit can be achieved with a much less invasive procedure.

“What we’re really trying to study is how effective is this treatment?,” Rothstein said.

The study will divide its participants into two groups. One group will receive the treatment, while the other will be sedated, but won’t undergo any treatment. The participants won’t know which group they are part of, at least initially. The two groups will then be monitored to see whether they continue to need insulin.

After a year, those who are part of what Rothstein called the “sham group” — the cohort which did not undergo endoscopic treatment — will be offered the procedure if the study indicates they could benefit, and if they want it.

“I think it’s a phenomenal opportunity,” Rothstein said.

The study seeks adults with Type 2 diabetes who are on insulin, among several other qualifying factors. Those who are interested should call the Clinical Research Coordinator Sarah Westvold at 653-9017.

Rothstein, who is involved in another effort to find an outpatient procedure to help with weight control, said patients may soon have the ability to treat health problems with simple procedures.

“While I totally support the approach of surgery in appropriate places, unfortunately a lot of people are afraid of surgery,” Rothstein said. “We are starting to see less invasive, outpatient procedures that are effective for our patients.”

Funding for the Monadnock Region Health Reporting Lab comes from several sources, including The Sentinel and several local businesses and private donors. We continue to seek additional support. The newsroom maintains full editorial control over all content produced by the lab.

Funding for the Monadnock Region Health Reporting Lab comes from several sources, including The Sentinel and several local businesses and private donors. We continue to seek additional support. The newsroom maintains full editorial control over all content produced by the lab.

Editor’s note: This article has been updated to change the phone number people interested in the study should call.

These articles are being shared by partners in The Granite State News Collaborative. For more information visit collaborativenh.org.

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