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 recently 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. They continue to meet with health care providers for medical management and support as they work to improve their health.

In late 2021-early 2022, the patients underwent the Endogenex 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 Resurfacing, 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, Minn., had been dealing with Type 2 Diabetes since he was diagnosed in 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 drank a lot of pop. He educated himself on eating better in an effort to control his diabetes but did not see the results he had hoped. Although it was difficult, he successfully corrected his blood sugars early on in his disease process, but then became stagnant in his efforts and both his weight and blood sugars began to increase. He started taking one medication to control diabetes and when his numbers started increasing, he was prescribed a second medication. He was also diagnosed with high blood pressure and prescribed medications for control of that as well as high cholesterol.

 

Chad Visser, pictured in the back, lost 30 pounds after the Endogenex procedure and saw his A1C level go down 2.3 percent

 

“I would watch what I ate a lot and lost some weight, but it was not enough. It was a struggle and couldn’t meet my goal,” Visser recalled. “That’s when my physician said we need to crack down on your lifestyle or take the next step of going on insulin.”

When he was first diagnosed, Visser’s A1C was 10 percent. He learned how diabetes was affecting his body and became very concerned. After meeting with dietitians, three months of dieting, and not drinking pop, he was able to drop his A1C to 6.5 percent.  To briefly explain what the A1c results indicate:  5.7 to 6.4 percent indicates prediabetes, 6.5 percent or more indicates diabetes. Once diabetes is diagnosed, the goal is to keep blood sugars below 7 percent to minimize risk of complications. Unable to keep up with his new, healthy habits, Visser’s A1C unfortunately rose to 8 percent.

Because Visser was concerned about going on insulin, he needed 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 last November. He explained the procedure to be non-invasive and said a doctor basically zapped some cells to see if they would regenerate.

“The day of the procedure I was nervous to go under, but the staff was comforting,” Visser said. “The doctor and nurses calmed me down and talked me through the procedure telling me exactly what would happen. The procedure took only an hour and I went home feeling fine. The next morning, I went deer hunting with no issues, I wasn’t tired and had no pain.”

Four months after the procedure, Visser has lost 30 pounds, his A1C went down to 5.7 percent, and he was able to stop taking the blood pressure medication. “The procedure considerably helped my health,” Visser exclaimed. “I’m a lot healthier and have a lot more energy.” Now he’ll continue with follow up testing and counseling over the next months to keep him on track.

Auto mechanic Damon Graham of Aitkin, Minn., also underwent the procedure. At 49 years old, he had been dealing with Type 2 Diabetes since he was diagnosed in 2015. He didn’t like taking pills and hoped the procedure would help get him off his medications. He also thought that by participating in the study he would be able to take part in finding a treatment option for patients with diabetes other than medication.  He has children and since this is a genetic disease, he is doing this in hopes that a safe, effective treatment is available for them.

Graham started treating his diabetes by taking one pill in the morning and another in the afternoon. When that stopped helping, he started taking another medication. After five years, he also needed a blood pressure medication. Graham had been drinking Mountain Dew and ate a lot of candy bars. When he began eating and drinking right, and quit pop, he lost 10 pounds and his heartburn was gone. “I tried to improve my diabetes by not eating snacky, sugary foods but it didn’t go as well as I had hoped,” Graham said.

The patient underwent the procedure in February 2022.  “The procedure was not bad at all, the worst part was the IV needle,” Graham 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 two inches smaller. His A1C has decreased and he has been able to stop some of his diabetes medications. He works out at a gym three to four times a week and feels much better.

 

Damon Graham, pictured above, was able to lose 25 pounds and has been able to stop some of his diabetes medications after the Endogenex procedure

 

“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.”

Type 2 Diabetes is a progressive disease in which the body has difficulty maintaining normal blood sugar levels. Over time, excess sugar in the blood damages blood vessels, kidneys, eyes, and other tissues in the body. Research shows that cells in the lining of the small intestine play an important role in controlling blood sugar levels. In individuals with Type 2 Diabetes, these cells may not function properly.

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,” Dr. McCollister said.

In the study, patients first meet with a clinical specialist and undergo an upper gastrointestinal endoscopy and other therapeutic procedures. Dr. McCollister said that the person then comes to the hospital’s pre-op area, is given an IV, and taken to the OR 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 40 to 50 minutes. The patient stays at the hospital for a short observation period and is discharged home. The individual comes back for a follow-up endoscopy after four weeks to make sure the procedure did not create any issues. So far, patients have had very few symptoms, no pain, and no bloating.

“For the five patients in the study to date, there have been lots of positives,” Dr. McCollister stated. “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. “Being involved in the study from the beginning, involved in this very exciting study is very rewarding,” said Dr. McCollister, adding that the Mayo Clinic and the University of Southern California were also approved for the trial but have not begun patient studies. This clinical trial to demonstrate safety has secondary goals of efficacy and the effect on blood sugar. The study will continue at CRMC for another four years. Larger trials will be completed for about two years until the FDA approves the procedure for actual clinic use in diabetes therapy.

CRMC Surgeon Dr. Paul Severson, who is working with Dr. McCollister as a principal investigator, is also pleased with the study’s profound results to date. He said patients feel better, are happier, and have a brighter future. He also relayed how exciting it is to work with Endogenex and be at the forefront of discovering how to help diabetics. “The company is based in Minnesota and came to CRMC to work with engineers to develop the technology needed to conduct the study,” Dr. Severson said. “In the next phase of the study, there will be a better device and more energy used which is expected to provide even better results. This will help millions of people; I’ve never been more excited about a study.”

A second group of patients will be enrolled in the study this Summer. 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. Once patients are screened for the study, they undergo the Endogenex procedure and then attend follow-up visits over the next year to assess progress and wellbeing. They undergo blood tests to monitor nutrition labs and receive lifestyle and diabetes counseling. There is no cost to participants for care provided as part of the study. A stipend for study-related expenses is provided.

To learn more about the study and potentially participating, please visit www.regent1study.com, send a message to regent1study@cuyunamed.org, or contact the coordinator at 218-546-2505.

 

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