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Hello, again, everybody.

I'm Ray Gildow and welcome to Lakeland Currents where we have a really exciting topic today, and if you're a person who's in this condition you're going to really appreciate what we've got to say.

We're going to be talking about a new clinical study that investigates a way to treat type 2 diabetics, and my guests today are working on this clinical study, and I think you're going to find what they're doing absolutely fascinating.

Melissa Dyrdal is a nurse practitioner from the Cuyuna Regional Medical Center, and Dr. Howard McCollister is from the Regional Center, also.

He's been on our show a number of times over the years.

Welcome to Lakeland Currents.

Thank you.

Thank you for having us.

This is really an exciting project.

But Melissa, let's just talk a little bit about your background before we get into the actual study.

Okay, thank you.

Surgical technician is where I started my career in medicine.

I guess I was a nurse's aide before that for a while, and then eventually over time just kind of went back to school LPN, RN, bachelor's and then eventually ended up in nurse practitioner school.

I did do family practice for a couple years, but then returned to the Medical Center to help start the reflux program, Minnesota Reflux and Heartburn Center, along with bariatrics, the GI lab, surgical and medical bariatrics at this time and then the GI lab.

So, many of those years were spent assisting Dr. McCollister and Dr. Severson and the others in surgery.

Have you had to take special training in diabetics, diabetic issues, to be involved with the study?

Not necessarily.

I think, you know, primary care--it really just is something we see in any of the patients that we see.

I mean it's a very common disease for people to have, and you know it's through training, you know, nursing school and the nurse practitioner school, certainly that is one of the diseases you learn about, but again just kind of along the way because it is something we deal with every day with patients.

This was just an amazing opportunity, and I was just lucky enough to be at the right place at the right time.

Dr. McCollister, maybe you could tell us a little bit about your background, and then maybe you could tell us the difference between type 1 and type 2 diabetics.

We have, I have been practicing for 47 years.

It doesn't seem like that long but it's been 47 years, and 35 years at CRMC.

And my role has primarily started out as a general surgeon and then as the technology of surgery became more advanced we began to specialize and sub-specialize and do a lot of advanced laparoscopic and endoscopic surgery as well in the treatment of a variety of diseases: reflux disease, heartburn, obesity, those types of things.

So that pretty much has been my career there.

And you've really been a leader in the state, I think, for some of those issues.

We've tried to be.

Both my partner, Dr. Severson, and I have been very passionate about moving the ball down the field in terms of more effective ways to deliver surgical, solve surgical problems, and so that has been a gratifying 35 years.

But both Dr Serverson and I have recently retired from clinical practice and pretty much focus entirely on this study that we're doing.

When you look at this kind of an issue, there are about, we looked it up, about 30 million Americans have diabetics, type 2 diabetics.

What causes that and what's the difference between a type 2 diabetic and a type 1 diabetic?

Type 2, a type 1 diabetes is typically a disease that may or may not be genetic it tends to disrupt the physiology but it could occur at all ages.

Type 2 diabetes is more often acquired, used to be called adult-onset diabetes, and this is acquired and the alarming thing about that, as you mentioned, 30 million Americans suffer from diabetes, but the problem with that is that it's increasing.

It's been increasing dramatically over the last 30 to 40 years, and this is associated with the increase in obesity.

As the weight has gone up, the American diet has changed to the point where it's promoted this and created that particular problem.

This study that we're doing and the treatment focuses primarily on type 2 diabetes.

That is a little bit easier to treat, and has a little more accessible physiology.

It gives us more of an opportunity to intercede and actually, hopefully fix the disease.

How does a small rural hospital, small relative to the big hospitals, get involved with a project like this?

Right place, right time.

We have been associated for many years with a company down in the Twin Cities called Endogenex, and they do a lot of of engineering, bioengineering, those types of things for these types of problems.

We've been working with them--Melissa, Dr. Severson, and I have been working with them for the last several years in developing a means of coming up with the equipment necessary to deliver the energy necessary to accomplish the treatment that we want to do to be able to fix this problem.

Our study partners in this, and we've been working with Dr. Abu Dayyeh at the at the Mayo Clinic, Dr. John Lipham at USC.

So the three, those three institutions together have been working, of course, getting this problem addressed.

So what's the normal treatment for type 2 diabetics?

Traditionally the only tool that we've had for dealing with diabetes has not been to actually address the diabetes, but to address the blood sugar.

The problem with diabetes is that it will cause excessively high blood sugar because the body can't utilize it, and so as a result, we know that there are various drugs, the most common one is insulin, which was discovered about 100 years ago, and by using insulin we can actually force the body to utilize that glucose and keep blood sugar low.

But that's not treating the disease.

That's not treating the cause of diabetes.

Years ago, 10 to 15 years ago, we began to note that a lot of the metabolism, the physiology of diabetes, actually was taking place in the duodenum.

It was being managed by cells in the duodenum, which is the first part of the first part of the small intestine.

This is a part that comes right after the stomach.

It's accessible by endoscopic treatment, and it allows us access to those particular cells.

So what we do, we know that if we go in and we change the lining of the duodenum there, we can actually change the way the body responds to carbohydrate loads and those types of things.

How long is that?

How long is the is the duodenum?

The duodenum is probably about, maybe about, 30 centimeters, 40 centimeters long.

Okay.

And we utilize, it's in 3 parts, 4 parts, and we address primarily the second and third part, and sometimes the fourth part, because the cells that line that part of the small intestine allow us to, they're the ones that are creating this issue with the management of the blood sugar itself.

So people that have type 2 diabetes that might be way overweight, can they stop having a problem if they lose a lot of weight and get back to maybe a normal range?

Well I think lifestyle diet modifications is another, you know, way we have utilized treatment for this, as well, along with oral medications.

And again, if it gets too out of control, particularly well, for type 1 that's, you know, treatment.

But for type 2 you start using multiple medications, and pretty soon people can end up with insulin.

So dietary choices are certainly a part of that, as well.

Interesting.

So when you started doing this process, you said you work with the Mayo Clinic also?

Yes.

So there's three sites involved currently.

Three sites?

Are you all doing the same research?

Yes.

So this is, just to kind of say, this is the Endogenex Regent 1 U.S Clinical Trial.

But again, three sites in the United States: Crosby-Cuyuna Regional Medical Center, which we're proud of, Mayo Clinic also in Rochester, and then USC out in California.

But we also have sites in Australia, Netherlands, all working on this particular.

I will say in, I believe it's Amsterdam, they are doing this technology on people utilizing insulin, so that's the big difference.

A lot of this is driven by restrictions placed on us by the FDA.

Different countries have different regulations on that, Australia has one particular set and the Netherlands, at the University of Amsterdam, they work with a different set of restrictions and that type of thing.

So each study is designed differently, in terms of how this is done.

So could you walk us through a little bit, if I come in to see you, and I want to be a part of this study, what's going to happen to me?

What's going to happen to you?

Well you get to meet the team, for one.

That's all good, I'm sure.

It is good.

We do, I have a picture of the team here.

So Dr. McCollister PI, Dr. Severson is Co, Dr. Angelina Ausban is also our internal med physician who is a major part of the team, along with myself, Heather Erickson, and then Melissa Deseth, who are in the diabetic area of our hospital education and things like that managing those patients.

So the big, there is criteria like we mentioned.

It is, there is a long list of exclusions, inclusions, these types of things.

I say the main thing is you do have to have had type 2 diabetes currently, I always kind of say, and you cannot be on insulin at this time.

And I always like to say it doesn't, you know, doesn't mean never, just not now as we move through the first in human trials of this.

So far 10 have been done in the United States, 8 of them at Cuyuna Regional Medical Center.

Wow.

That's really amazing.

Yeah and it's been a great experience.

And then 2 at the Mayo Clinic, so far.

So we are currently recruiting for the next phase.

We are in generation 2 of this, and again, type 2 diabetes, on oral medications only at this time.

We are looking for 2 or more.

And, then also, having type 2 diabetes for more than 2 years but less than 10.

And there is a whole other list of criteria that go along with that, but that is what our job is.

So if those are things, and we can show you at the end, there is actually a QR code you can scan.

It'll bring you to a survey, which will ask you kind of those basic questions, and from there, if you qualify, it'll send an email to myself or the other two coordinators, and from there we will contact you and kind of work through that.

So if I meet your qualifications and I come into the clinic what's the the first thing you're going to do with me, physically?

Well, first I'm going to sit down, and I'm going to tell you all about the study.

There's about, we spend about an hour together just talking about, you know, just the study itself--the risks, the benefits, you know.

Again this is first in human in the United States again and elsewhere, but we go through all of it in detail there.

It is pretty rigorous because it is a study.

There are a lot of follow-up visits.

There are a lot of lab draws, just things as we're walking through and looking for the safety of this device, at this time.

We've been seeing amazing results, particularly in A1C's, lowering of blood sugars, and there are a lot of other things that we are also seeing along with it.

So it's been pretty exciting.

But we'll just talk about that process.

I'll talk to you about the procedure itself.

It is free.

It is a free trial.

You actually get paid some money at the end.

They, you know, in thanking people for being part of this.

We can't advance in medicine unless we have people who are willing to, you know, we kind of tease and say are guinea pigs.

But, you know, it is, it's so great, and I say in this area it's been so exciting for, I mean people are just excited to be part of the study.

So that's been fun, too.

But from there we talk about the procedure itself, and then we'll also just kind of talk about the process and then sign the consent.

And if it's something that you're wanting to get on board for, from there we will look at your records.

And then we kind of go through those, and then again that's my job, and then the two, Heather and Missy, who work with me on this, fine-tooth combing making sure we meet all of the criteria, and if all looks good we kind of move you to the next phase which you meet with Dr. Angie Ausban and she will go through all of, you know, your history and your labs and all the things.

There are some initial screenings that we do testing for this, and once all of those boxes are checked off, we set a procedure date.

What might some of the risks be?

Well, at this time, I mean Dr. McCollister can speak of that, too.

It's really, I mean some of it, we like to tease to say it's first in human, we're not sure.

But the risks at this point are pretty much the same as if you had an upper endoscopy.

The, again, this is an FDA approved trial, so we're subject to a lot of the regulations and oversight by the FDA on this thing.

So it is, Melissa has done a great job, and our whole team has done a great job of working with the FDA and getting this set up in such a way that it can be accessible to our patients, and that's the most important thing.

Once the procedure itself is scheduled, this is done in the operating room, typically at CRMC, is done using a conventional endoscope that we use many times a day in order to access the stomach and the duodenum.

Once there it allows us to deploy a special catheter that we have developed over the last so many years.

We deploy that catheter in the duodenum, and in doing so it allows us to deliver a certain amount of energy to the lining of the duodenum, the cells that are actually sending the inappropriate signals.

We're looking at this area right here.

Yeah.

And it's sending inappropriate signals to the metabolic axis that is helping to control the blood sugar.

And so we know, that if we ablate those cells, the more of them we ablate that, when they regrow, they will actually regrow as normal cells.

So they're defective.

We destroy them and then they regrow as normal cells.

Is that something that was known before your study?

No.

Okay.

I always like to say so there was, there is another treatment out there similar except they use thermal.

So it's different; there is a difference.

They use radio frequency energy like your microwave.

Okay.

So what that will do is that the problem with that is it causes a lot of thermal destruction of the lining--the possibility of injuring the duodenum again and burning a hole in it or strictures or that type of thing.

And that was something that we wanted to avoid, so we developed, and I say we but it was primarily done at the Mayo Clinic and Endogenex, and what they have done is developed a technique of delivering this energy in such a way that that does not use higher frequency, does not use heat, and does not damage the full thickness of the duodenum.

It's just that very, very superficial layer and we're able to control that very precisely.

So we basically burn away that, you know, inner layer, and then we note over the next period of time, over the next year, what the response to that is in terms of response to blood sugar.

We have made changes as we've gone along in this approved by the FDA that have actually allowed us to increase the amount of surface area that we work on inside, and we have found that increasing the surface area in terms of destroying those cells has had beneficial effect.

The risks are primarily the risks of endoscopy, which is again something that we do several times a day.

It's a very, very common procedure.

The risks are very low level and very uncommon, in this particular setting.

And our finding, the original charge, the study design approved by the FDA was to demonstrate safety of this.

It's a first in human trial, meaning that they're saying, "Okay, you've done this on a number of experimental animals.

Now we're going to try it on humans because we've demonstrated it to be safe."

And so what we have found, in the 10 patients we have done, is it is indeed safe.

I think that one of the worst, significant complications we've seen has been a sore throat.

And that is unavoidable, I suspect, because we have a scope going down into the stomach, but that's a very transient thing.

It's entirely an outpatient procedure.

It takes us about 45 minutes to an hour, and patients go home.

There are some, within the parameters of the study, there are some post-operative restrictions relative to diet, as you might expect, but from a standpoint of activity people resume normal activities that afternoon or the next morning.

Wow, that's amazing.

It is also a year-long study.

I think that's something.

And you also are given a continued glucose monitor that you wear for a year.

I think that's been another one of the kind of fascinating things for people, too, is there, you know, all these things we have been talking about for years and what some of these foods and drinks can do and now they're actually able to see what's happening.

So it's been fun to kind of listen to that.

Are you wearing one right now?

I did wear one for a month.

It was fascinating.

She wore one of the glucose monitors and she's become a true believer in the value of that.

Because you can, I mean, you of orange juice and you can watch your blood sugar spike.

It's very interesting.

So I think it's a combination.

I think the other thing you asked about was, you know, why this space, and you can speak more to this, too.

We learned a lot about the duodenum.

It became of interest after the gastric bypass, the weight loss surgery, because people literally left the hospital non-diabetic, I mean their blood sugars.

So it became an area of interest, and so that's how studying became in that area.

About 15 years ago we began to notice, not me, but we globally, bariatric services around the world, noticed that if we did a gastric bypass, which basically bypasses that duodenum, that first part of the small intestine, that people that came to us with very hard to treat diabetes, their blood sugars were normalized.

And they would normalize right away.

Not on the basis of losing weight, but on the basis of the duodenum being bypassed.

And so as we began to investigate why that was occurring.

We began, we uncovered this little chemical factory going on inside the duodenum which was having a huge effect on the way that the body responded to carbohydrates.

And so that would become the focus of this thing.

And a lot of things have been tried.

All of them safe, but some of them a little bit on the weird side from a standpoint of bypassing the duodenum, but it has confirmed what has been found.

And now we're finding that by ablating, by destroying, by getting rid of those abnormal cells and then allowing them to regrow as normal cells, that we can restore some of the normal and expected physiology relative to blood sugar.

And our data to date, I want to emphasize this is relatively early in the study, the data to date has been very, very encouraging, very suggestive, very safe.

And it's really been kind of a remarkable journey.

The implications are astounding in terms of what this can mean to society, particularly the aging population.

You said that it's going to take a commitment after they're done to do some changes.

What are some of those changes they would have to do?

Well, I think Melissa can speak more to it than I can.

But the aftercare and the after management, the patients do have to monitor their own blood sugar, and that's important.

We want to keep track of that.

We also do ongoing and periodic lab work to track their hemoglobin A1C, which measures what the body's glucose level is doing over time, those types of things.

But Melissa can address the subsequent year.

It is a year-long study.

We do want to keep contact with these patients.

The patients that we have done this on have been real troupers and just wonderful people to work with--very enthusiastic, very grateful--and we're grateful to be able to give the opportunity.

Is there any age limit one way or the other?

Yes.

Right now 22 to 65 is the age limit.

We also, like I said, I mean there's a whole, these are just some of the brief ones, but that is our job once we're contacted and work with you is to go through the specifics of this.

But, you know, some of them ages 22 to 65, again, type 2 diabetes, more than 2 years less than 10 years.

So there's quite a small box here for this, hemoglobin A1C between 7 and 10, BMI 24 to 40, to just name some of them.

But I think along with the procedure itself, we are also meeting with you on a regular basis.

We're talking about diets.

There is life coaching for those types of things, too, and so it's really just a health and wellness, altogether type thing.

Again it has been a joy and really just a fun adventure.

I think for the patients, too.

We just finished up in October, a patient that finished up the year-long study and he just said, "This changed my life."

We are seeing, so it is for, you know, treating type 2 diabetes blood sugars, but we are seeing other things.

We've had a couple patients come off their blood pressure medication.

We've been seeing some things with cholesterol, and there's just kind of a fascinating weight loss along with it, too.

Some positive side effects.

Yeah.

So it's been, I think again, it's an overall kind of health and wellness type thing.

And just the patient, our eighth patient we just did a few weeks ago she's, you know, just a few weeks into it, and she's just already, "This has changed my life."

So it's just an exciting journey, and I just hope to continue in moving forward.

Is this something?

You're going to say something.

Well, I think that people who don't have diabetes sometimes can't really appreciate the imposition that this makes in life.

It's a terrible disease, and over time it can cause destruction to a variety of organ systems in the body.

So the ability to address this, the ability to to actually normalize the blood sugar, to actually get rid of the the problem itself, to actually solve the problem so that we don't have to use medications or insulin or anything like that to control the blood sugar, that's an opportunity that is just really exciting.

And things are so promising to this point, that we're very excited about it.

We've just finished phase 1 ,and again, sometime in the next 4 weeks we'll start phase 2, which is a little bit different parameters, a different type of hardware that we're using.

We're very excited about that.

So this has been, this has been very, very interesting.

Maybe you could give the information about how to contact you.

Yeah, let's do that.

You know, like I said, we're recruiting.

This is exciting and, you know, it's a fun journey.

We do have a QR code and we have contact numbers along with emails.

regent1study@cuyunamed.org That will get you to myself and Missy or Heather.

Who is the initial contact for this.

The hospital's website itself, Cuyuna Regional Medical Center, and then the QR code is actually kind of fun, when you scan it, and it will actually take you to a survey that really just asks those basic parameter questions.

If you qualify, or it looks like you'll be, I shouldn't say qualify, but if you're a potential candidate based on the answers to those, it will send us your contact information, and then we'll contact you from there.

We're really grateful.

We do have to recruit because, you know, we have to advertise, so saying that, you know, we're doing this study and if you meet these criteria we'd love to have you come in and talk to you and see if there's something you're interested in.

It is not as easy as you would think because the list of exclusions is relatively long, that the FDA has imposed, and so we have to make sure that we have just the right candidates.

And that has been a little bit of a challenge in this situation.

Nevertheless, we have accomplished that.

We're going to continue to do that, and we think, going into phase 2, it will become easier to get people participating.

Well, thank you for jumping on.

We're out of time.

Fascinating study and for the folks that are watching the information will be posted at the end of the show and if you're interested contact the Cuyuna Regional Medical Center.

It's an amazing study.

I'm Ray Gildow.

Thanks for watching.