December 28, 2012
NIH Podcast Episode #0175
Balintfy: Welcome to episode 175 of NIH Research Radio. NIH Research Radio bringing you news and information about the ongoing medical research at the National Institutes of Health – NIH . . . Turning Discovery Into Health®. I'm your host Joe Balintfy, and coming up in this episode, as promised, a special audio documentary of what it’s like to participate in a clinical research trial. You’ll hear how over the course of about 6 days and 5 nights, I experienced a variety of mostly harmless tests that will hopefully help move research forward on understanding narcolepsy.
These are tests that are very popular in the sleep field –you know, you are the control for subjects with narcolepsy, and these individuals have interrupted sleep.
You’ll be introduced to the BOD POD, the metabolic suite and DEXA machine, as well as get a feel for what it is like to stay at the NIH’s Clinical Center here in Bethesda, Maryland.
But first, an important program note. NIH Research Radio is introducing a new and improved format starting next year with our next episode. First, you’ll be able to hear NIH Research Radio twice as often – I’ll be bringing you new episodes every Friday, rather than every other Friday. Also, each new episode will typically focus on just one topic, rather than several. While there won’t be a news update in this episode, Craig Fritz will continue to provide summaries of breaking news, and you can continue to expect a variety of experts, health research topics, and the high production quality you have come to expect.
Again, coming up in this episode, participating in a clinical research trial. That’s next on NIH Research Radio.
(BREAK FOR PUBLIC SERVICE ANNOUNCEMENT)
Participating in a clinical research trial – Part 1: Arrive and diet
Balintfy: If you’ve been listening to NIH Research Radio for a while, you already know I volunteered to participate in a clinical trial. Back in episode 163 I shared a taste from my outpatient experience. Now I’m bringing you a more in-depth perspective from my in-patient stay.
[Sound: “Hello, you’re back? Thank you.” Door]
Balintfy: I checked in at 5 o’clock on a Sunday evening. All of my admissions paperwork was ready for me so I quickly got to the Metabolic Unit where I would be staying for most of my visit.
Victorino: “OK, so this is your room, it’s a private room, every room here is private…
Balintfy: And it was a familiar face (and voice) my fist evening, clinical research nurse Milalynn [Mile-lyn] Victorino who goes by “Mikee”. She not only showed me around my room and the whole unit, but refreshed my memory on some of the daily activities I had to look forward to, namely a daily height and weight check, vital sign readings four times a day, both resting and standing. And the reminder that I would be on a special fixed diet.
Victorino: So once you are able to order a regular meal. So this is your menu. So not until you leave. The afternoon before you leave.
Courville: So basically, what you're going to do for the study is we put you on a special diet where we weigh all the foods.
Balintfy: That’s Amber Courville, she’s a clinical research dietician who helped explain how my diet was created for this study.
Courville: And then also we can try and keep your weight the same so that drops in weight or increases in weight, that doesn't affect the study, okay? So it helps us control at least one more variable.
Balintfy: She says the cooks weigh everything to make sure that every nutrient is exactly where they want it.
Courville: So for this diet, basically what it's going to be is a diet that's calorie controlled, like I said, to try and keep your weight right, and then also macronutrient controlled so it's going to have exactly 50% carbohydrate, 30% fat and 20% protein. And then even within each meal we have specific guidelines. So anything that you don't eat could throw all that off. So when you are choosing these, you want to keep in mind that for five days you're going to have to eat absolutely everything that we give to you and nothing else, because again, if you eat something else, that could influence the different ratios and throw everything off.
Balintfy: So my first meal in the metabolic unit is a salad with a half dinner role, point-8 grams of margarine. I have a sugar cookie, actually its one and a half sugar cookies. And 56 grams of salad dressing, fat free Italian at that.
Participating in a clinical research trial – Part 2: Tests and more tests
Balintfy: My first full day as a healthy volunteer for this research study, got an early start Monday morning and was full with a series of test. The first, which I didn’t even have to get out of bed for, was called indirect calorimetry.
[Sound: plastic and humming]
Balintfy: A plastic hood was fitted over my head by Megan Mattingly, the nurse coordinator for this study who is also a captain in the public health service. She explained later how this machine analyzes the gasses that I breathe.
Mattingly: This gives an estimate of what your resting metabolism would be, so about how many calories your body burns while at rest. And according to this, you burn about 1632 calories so that's your resting metabolism. So lying in bed, doing nothing, that's how much your body needs as far as energy goes to maintain your current weight.
Balintfy: I had this test done twice, first on an empty stomach, then again after eating. My next procedure was to be fitted for a Holter monitor.
Sandra: All right. Well, I'm Sandra. I'm the EKG tech down here in our station, the female EKG tech. What I'm doing today is I'm placing a 24-hour Holter monitor on you. It's an EVO monitor. It's one of our newer monitors. And what it's going to do is it's going to record you for the next 24 hours to give us an idea of what your heart rhythm is looking like. So this will be able to detect if there are any arrhythmias, any type of electric deficiencies with your heart or things along that line of monitoring.
It's a small monitor. It weighs about four and a half ounces. And this monitor, the bright side to this, because the older monitors, I mean they've gotten smaller over time but the good part about it is that now this one actually has a window. You could see your heart rhythm actually going by on it, current times flashing on the front of it.
So what I'm going to do to you first is this Holter monitor has four lead wires coming from it that are attached to electrodes, and I'm going to clean and do a good skin prep on you on the four spots that I'm going to actually place the monitor electrodes on.
I'm also going to give you a pouch. And you're wired for sound. You're good to go.
Balintfy: Thank you.
Sandra: You’re welcome. Have a great day.
[Sound: door, curtain pull]
Balintfy: Back in my room, I had more tests with Megan Mattingly, including neuropsych testing. I asked her why these tests were included in the study.
Mattingly: Patients with narcolepsy have changes in cognitive functioning, and the sleepiness that they have because of the narcolepsy impairs the cognitive function that especially has to do with complex processing tests. So a lot of the neuropsychological tests that we do are evaluating sort of the memory and complex processing tasks. So even though some of them seemed rather tedious, there was some complex processing being evaluated.
For instance, the one test where you had to draw or copy a diagram and then later sort of remember and draw it again, that is evaluating specific different functions such as visual spatial abilities, memory, attention, planning and working memory; and all of those sort of fall into the big category of executive functioning, and most of these tests are evaluating some aspects of executive functioning.
Balintfy: Most of the other tests during the week were looking at my body composition, fat distribution, endocrine function or how my hormones are working as well as my metabolism. Remember, metabolism or energy metabolism, is basically how we burn calories. And in people with narcolepsy, which is a chronic disorder of the central nervous system, their metabolism works differently. So I’ve already had one measure of my metabolism, the indirect calorimetry, that measured my resting metabolism, or resting energy expenditure, the next measure is in the metabolic chamber.
Balintfy: Barbara another nurse in the metabolic unit, gave me an orientation of the room, emphasizing that it has many of the same features as a regular room, and that I can bring a laptop as well.
Barbara: Oh, yes, definitely, anything that you need to get through the 23 hours. I mean we're not cruel. We don't want you just staring at the wall. Like I said, there's a television. There's a computer there also. Most patients that come up here, they do have their individual laptops.
You also have access to the patient library which we can give the number and you can call and request any tapes, videos, DVDs or books, and then we can have the librarian or escort bring them to you. And again, we can deliver it in the first little square box, and then whenever you get finished with it you can give it back to us or you can take it downstairs the following day.
Balintfy: And I have a window.
Barbara: You have a window, yes. It's really pretty in the wintertime. You can see the snow.
Balintfy: So it's basically airtight.
Barbara: It's definitely airtight.
Balintfy: While in the metabolic chamber – where I stayed for 23 hour straight – I had to do my own daily measurements: temperature, heart rate and blood pressure. Without those regular tasks, the meals served through those special air-tight exchange boxes, and the DVDs I got from the library, it was uneventful. A more interesting test from my perspective was the BOD POD the next day.
Idelson: What the BOD POD essentially does, it will essentially measure the change in pressure when we put you in there compared to an empty situation on the BOD POD, and it will compare and it will calculate total body volume. And then we'll do a breathing exercise, and I'll get more into that later.
Balintfy: Chris Idelson is a lab researcher, what they call a postbac IRTA here at NIH. He explains how this device uses a lot of equations. But I have to strip down to swimwear, including a cap for my head, and breath into a tube while I’m closed in what that looks like a man-sized egg with a window. The test itself is simple, the chemistry and physics behind it complicated, and results very thorough and detailed.
Idelson: All right. So as I mentioned, the BOD POD measures percent of body fat tissue as well as fat-free mass. It also gives you total kilograms of body mass as well as body volume, your lung capacity, essentially your thoracic gas volume. The only other value that we kind of focus on is this RMR and that's your resting metabolic rate. Essentially if you're to do literally nothing for an entire day, you'd still burn about 1600 calories. And with your average low active day, it would be about 2400 roughly, and with an active day about 2750. And then if you had a sedentary day where you didn't do anything or a very active day when you did a lot, you burn those calories as well, just a general estimation. So this is for you to hold on to and reference whenever you want.
Balintfy: Thank you.
Idelson: No problem. You're all finished.
[Sound: bed adjust]
Balintfy: Well, all finished with the BOD POD. At this point, I’m about halfway through my week. I’m back in my room in my adjustable hospital bed, where Mikee hooks up an IV for some blood draws, including a blood-glucose test much like what pregnant women take to check for gestational diabetes – I get to drink a big cup of a super sweet drink.
[Sound: drink pour]
Victorino: And once you finish I start the clock and that’s when we start the three hours.
Balintfy: I will have several blood draws over three hours.
Victorino: So 30 minutes, 60-minute, 90 and then 120. So between 120 to 180 you’ll have one hour so that completes the three hours of the test.
Balintfy: Another test involved taking a pill. I asked the principal investigator of this study, Dr. Giovanna Cizza about this part of the study.
Cizza: One of the objectives of this study is look at the endocrine function of subjects with narcolepsy.
Balintfy: Dr. Cizza explains the endocrine system is the adrenal system. There are two glands above the kidney and these are our stress glands.
Cizza: So this test which called dexamethasone -- dexamethasone, is a synthetic steroid, which is used in clinic, is a therapeutic agent.
Balintfy: He says it will slow down the adrenal function. Then later another hormone is given to stimulate adrenal function.
Cizza: This is a test that was validated actually in the NIH Clinical Center and was used to diagnose a disease called Cushing disease which is a tumor of the -- it could be either of the adrenal or of the pituitary.
Balintfy: In this study, he wants to see how the adrenal glands perform when slowed or stimulated. He also emphasizes the importance of the neuropsych tests, as well as reaction time tests I had to take.
Cizza: Well, these are tests that are very popular in the sleep field because, you know, you are the control for subjects with narcolepsy. So these individuals have interrupted sleep and this impacts a lot their quality of life as well as their neuropsychological functions. And with this test we measure memory; we measure some other kind of skills. And the reaction time is a very sensitive index because it's measuring milliseconds; and when someone is sleep-deprived, it does change. We're much slower and much more sluggish in our reactions.
Balintfy: I was feeling pretty sluggish myself as the week drew to a close. Much of my time had been spent in bed, or near bed. As part of the study design, I was pretty sedentary. As a guest of the NIH Clinical Center, I was grateful for the friendly and clean surroundings, and the resources available, including the Patient Library where I got a few DVDs. I talked to Martha Caro there about how it is a unique library among others here at the NIH.
Caro: We kind of serve I guess as a smaller, more intimate version of a public library. I usually say we're a patient library so we cater to the patients and their families who are here to participate in the clinical trials.
We try to give a little bit of everything, and we also get the daily newspapers as well as magazines. So a little piece of back home. If you were visiting a bookstore or a library back home in your town, a little piece of home here at the Clinical Center.
Balintfy: By the way, those videos were free and in just a moment, how much I could have been compensated for my time. That’s next on NIH Research Radio.
(BREAK FOR PUBLIC SERVICE ANNOUNCEMENT)
Participating in a clinical research trial – Part 3: Conclusions
Balintfy: Some of the last tests I had as I participated in this clinical research trial were an abdominal Computed Tomography or CT scan, and one called a DEXA scan. They both involved a little radiation. I couldn’t take my recorder to the CT and the DEXA scan was basically quiet so no sound to share, but they both showed images of my body density. I asked Dr. Cizza how all these scan and measurements – including the indirect caloimetry, metabolic chamber, BOD POD, DEXA scan – are all different.
Cizza: Actually, they don't measure exactly the same thing. For example, when we do the indirect calorimeter with the hood, we ask you to lay still and do not move. So what we try to measure at that point is the so-called resting energy expenditure, the expenditure that we need to keep our body alive.
In the metabolic chamber, we measure how much oxygen you use and how much CO2 you produce, but we allow you to move. So there we measure what we call the total energy expenditure. So that's not identically similar.
Now, the BOD POD and the DEXA machine do measure the body composition, so that is correct that they measure the same thing. However, one, the DEXA machine requires a more expensive machine. There is a minimal amount of radiation, different from zero. The BOD POD does not involve radiation. And so we wanted to compare how the results obtained from a more sophisticated measure compare to the other test; and eventually, we may in certain situations substitute one with the other.
Balintfy: He points out that after this study, I will not only be helping his research, but will be walking away with whole lot of information about my own metabolic health. And if I had been just a regular, healthy volunteer, not doing this for NIH Radio, Megan Mattingly the research nurse says I would have also been compensated monetarily.
Megan: The total compensation for this study for a healthy control who has all of the tests including the screening visit is approximately 800 and something dollars. You get reimbursed or remunerated for your inconvenience basically is how we put it, and the tests that are more inconvenient get more remuneration.
So for example, the tests where you need to fast and you have frequent blood draws, we determine that that's more inconvenient than a test where you're wearing a watch for an entire week, and so the compensation reflects that.
Balintfy: She reminds me, this study does a lot in a week’s time.
Megan: We start with just studying energy metabolism, resting and after you eat, and throughout the week you're given a diet that is very controlled so that you maintain your weight throughout the study, but also it has certain percentages of carbohydrates, proteins and fats. Then there are just various tests that look at different aspects of metabolism, and the entire stay we are monitoring your sleep and your activity, which we realize is limited because you're just constrained by being in sort of a hospital environment.
There are multiple tests that look at body composition, fat distribution. We look at your cognitive functioning because those people with narcolepsy sometimes have impaired cognitive functioning and we need to compare our healthy controls to those who have narcolepsy; and tests that evaluate your endocrine function or how your hormones are working in your body.
Balintfy: Dr. Cizza tells me that the study may wrap up soon and then the work will be going through all the data they have collected.
Cizza: We have now 19 patients with narcolepsy, and so we need to have 19 participants like you to match those. And I think you are the participant -- actually, I'm grateful that you're participating in this study. You're participant number 11.
Megan: We do hope that study participants, healthy volunteers and actual patient volunteers don't have unpleasant experiences while they're here. You are giving up your time to help us and so we want to make everything as pleasant as possible. And I think that pretty much all of the research teams do strive to make the experiences as pleasant as possible for their volunteers.
Balintfy: For me, it was a pleasant experience, but I was also glad to be checking out – a week straight in a hospital, including 23 hours in a small air-tight room is not exactly a vacation. But I learned a lot, both about my health, and the science of health research – it is very precise and detailed, and done by people who genuinely care, and definitely know their stuff.
So my thanks go to all the people who worked with me on this project. And to you for listening to this story. If you would like more information about Dr. Cizza’s study, visit www.niddk.nih.gov. And to see if you would like to participate in a clinical research trial, visit the website clinicalresearch.nih.gov.
Balintfy: For now, that’s it for this episode of NIH Research Radio. Please join us again next Friday, January 4th when our next edition and the new format will begin. In that episode:
Glaucoma is a group of diseases that is one of the leading causes of blindness and visual impairment for Americans and many people worldwide.
In the meantime, if you have any questions or comments about this program, or have story suggestions for a future episode, please let me know. Send an email to NIHRadio@mail.nih.gov. Also, please consider following NIH Radio via Twitter @NIHRadio, or on Facebook. Until next time, I'm your host, Joe Balintfy. Thanks for listening.
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