CRMC diabetes patient study the first of its kind in US
Study aims to improve area residents’ health through procedure to improve blood sugar management.
CROSBY — Area residents diagnosed with Type 2 diabetes are expected to live longer, healthier lives with fewer health complications after participating in a trial study to help them manage their disease. They are lowering their risk of experiencing a heart attack, stroke, eye disease, kidney disease, and amputation.
For five patients who underwent a new, endoscopic patient study to treat Type 2 diabetes at Cuyuna Regional Medical Center in Crosby, results have included improved blood sugars, cholesterol levels and blood pressure. They have also reported weight loss, increased energy, and feeling overall improvement in their wellness. Most importantly, they are now living a healthier lifestyle by following a nutritious eating plan and being more physically active.
In late 2021-early 2022, the patients underwent the ReCET procedure, a non-surgical treatment that promotes the regeneration of cells in the small intestine to support better management of blood sugar levels. This novel procedure is being done under an FDA-approved clinical trial with the expectation that it will eventually be approved for mainstream diabetes treatment.
During the outpatient procedure named Duodenal Mucosal Regeneration, a doctor uses a small flexible endoscope under anesthesia to introduce a special catheter through the mouth and past the stomach to the duodenum, the first part of the small intestine. This catheter is used to apply a precise, controlled, electric current to the lining of the small intestine. This delivery of energy triggers the body’s natural process of cell regeneration, replacing unhealthy cells with new cells that help the body better manage blood sugar.
Chad Visser, a 51-year-old police officer from Ironton, had been dealing with Type 2 diabetes since 2017. He attributes his difficulty in maintaining good blood sugar control to his long hours at work, stress and frequent dining out. He would consume fast food during his workday and drink a lot of pop. His A1C was 10%, and he took medications for high blood pressure and high cholesterol.
“I watched what I ate and lost some weight, but it was not enough. It was a struggle and couldn’t meet my goal,” Visser said. “That’s when my physician said we need to crack down on your lifestyle or take the next step of going on insulin.”
Because Visser was concerned about going on insulin, he sought more help to improve his blood sugars. His first grandson was recently born, and he hoped to have more energy to play with his family. This motivated him to undergo the procedure which he says was non-invasive, in which a doctor basically zapped some cells to see if they would regenerate.
“The procedure took only an hour, and I went home feeling fine,” Visser said. “The next morning, I went deer hunting with no issues, I wasn’t tired and had no pain.”
Four months after the procedure, Visser had lost 30 pounds, his A1C went down to 5.7%, and he was able to stop taking the blood pressure medication.
“The procedure considerably helped my health,” Visser said. “I’m a lot healthier and have a lot more energy.” He will continue with follow up testing and counseling over the next months to keep him on track.
Auto mechanic Damon Graham of Aitkin also underwent the procedure. At 49 years old, he had been dealing with Type 2 diabetes since 2015. He also needed medication for high blood pressure. Graham, who had been drinking Mountain Dew daily and eating several candy bars said, “I tried to improve my diabetes by not eating snacky, sugary foods but it didn’t go as well as I had hoped.”
Graham did not like taking pills and hoped the procedure would help get him off his medications. He also thought by participating in the study he would help find a treatment option for patients with diabetes other than medication. He has children and since diabetes is a genetic disease, he wanted a new safe and effective treatment to be available for them.
In February 2022 Graham joined the study.
“The procedure was not bad at all, the worst part was the IV needle,” he said. “The next day, it wasn’t too bad, I never felt anything inside and just had a minor sore throat.”
Today, Graham is much healthier, having lost 25 pounds and is proud his waist is 2 inches smaller. His A1C has decreased, and he has been able to stop taking some of his diabetes medications. He works out at a gym three to four times a week and feels much better.
“Since the procedure, my doctor is thinking about taking me off my blood pressure medications,” Graham said, adding that if he needs a tune up, he’d be happy to have the procedure again. “The procedure helped me avoid having a heart attack or stroke and control my diabetes so I can be more active and lead a healthier life.”
Dr. Howard McCollister, a CRMC surgeon and the study’s principal investigator, is excited about the potential significance of this technique to treat Type 2 diabetes. He compared the new procedure to patients undergoing bypass surgery for weight loss and how their blood sugar goes into a normal range just days after the surgery. He said a person’s metabolic pathway is affected and the duodenum, the first part of the small intestine that connects to the stomach, is altered in its response to sugar and other such carbohydrates. He explained how this is important for blood sugar management because the duodenum directs the body’s metabolic response to carbohydrate intake.
“By altering the lining of the duodenum, we can change the way that a person’s body reacts to those carbohydrates,” McCollister said.
In the study, patients first meet with a clinical specialist and undergo an upper gastrointestinal endoscopy and other therapeutic procedures. McCollister said the person then comes to the hospital’s pre-op area, is given an IV, and taken to the operating room where general anesthesia is administered. Endoscopically, the surgeon goes into the patient’s stomach and positions the treatment catheter under direct vision and using X-ray fluoroscopy for guidance. The treatment uses a high voltage, low amperage current to cause the superficial cells to die and grow new ones. There is no bleeding, and the entire procedure takes about 45 minutes. The patient stays at the hospital for a short observation period and is discharged. The individual returns for follow-up endoscopy after four weeks to make sure the procedure did not create any issues.
“For the five patients in the study to date, there have been lots of positives,” McCollister said. “The procedure is safe and preliminary results are as expected; everyone has done well, feels well, and we have had no adverse effects.” He added that metabolic changes made to control blood sugar are well beyond what is anticipated from weight loss alone.
CRMC is the first organization in the United States to participate in the study; other sites include the Mayo Clinic and University of Southern California. The study will continue at CRMC for another four years. Larger trials will be conducted for about two years until the FDA approves the procedure for actual clinic use in diabetes therapy.
A limited number of patients are now being sought to participate in a second group. To qualify, candidates must have had Type 2 Diabetes for 3-10 years, currently use two to three diabetes medications, an A1C between 7.5%-10%, BMI less than 40, and be between 22 and 65 years of age. There is no cost for care provided as part of the study and a stipend is provided.
To learn more about the study, visit www.regent1study.com , send a message to email@example.com , or call 218-546-2505.
Peggy Stebbins is marketing and public relations director at Cuyuna Regional Medical Center.