Karen Elkind-Hirsch, PhD, Woman’s Hospital Research Director at Woman’s Hospital in Baton Rouge talks about how women are still at risk for diabetes after pregnancy.
Interview conducted by Ivanhoe Broadcast News in August 2019.
Just give me some history.
ELKIND-HIRSCH: Gestational diabetes is a well-defined disease that we know right now, like diabetes, because of the obesity epidemic, is skyrocketing. It’s a younger population that hopefully we can intervene and change the course of the disease, which in an older population, is much more difficult. But hopefully it can change these people from developing diabetes in their 20s and 30s. And then they’re going to have how many years of diabetes. So that’s part of the reason we’re so focused on this sort of young population.
That leads into the first question, which is just an overview. Can you explain what it is?
ELKIND-HIRSCH: Gestational diabetes is simply defined by the recognition of diabetes during pregnancy. It doesn’t necessarily mean you only have it during pregnancy. People say before I got pregnant, I didn’t have diabetes. I now have diabetes when I’m pregnant. We call it gestational diabetes. In a small group of those patients, they actually came into the pregnancy diabetic. They just didn’t know it. Because we now do universal screening, any female pregnant between 24 and 28 weeks gets a test for diabetes. And that’s standard of care, that’s standard of care here for 15 years and pretty much all over the country how they’ve gone to universal screening. It’s the recognition during pregnancy, but then there’s the group that it, quote, “goes away” in after they deliver. And then there’s a small segment that now have Type 2 diabetes that we can’t reverse.
If you could communicate one thing to any woman who’s watching this …
ELKIND-HIRSCH: Despite what you may be told is while gestational diabetes goes away after you deliver, your risk for Type 2 diabetes does not go away. Think of this as a warning, that you’re lucky that you’ve recognized that you are at risk and that one needs to make sure that they follow up on being checked for diabetes the rest of their life. In addition, your risk for cardiovascular disease, which we know now in women is the largest reason for death, and so you’re at high risk for that as well. So I think the biggest thing is we have found – and this is found in other studies – is you’ve got to get that baby weight off, OK? That’s key. Whether you’re obese or overweight or even thin, you want to get off the baby weight, and you clearly do not want to gain weight after you deliver if you’ve had gestational diabetes because again that is the factor that will push you over the edge on your body that’s already kind of just doing OK in terms of keeping your sugar in check.
Someone watching this, why should they care about this research?
ELKIND-HIRSCH: We say it’s research, but it’s actually our practice. It is the way we practice medicine here, and the understanding is, is that people need to know that they’re at risk, that it hasn’t gone away. I will say one thing, breastfeeding really does help in terms of lowering your risk because it increases your metabolism. So it actually helps you lose weight and keep the diabetes in check. The biggest problem is for a lot of women with gestational diabetes, they have a very hard time having their milk come in. We don’t understand why. So I always like to make them feel better because sometimes it’s very frustrating because they’re not making the milk that they should be making. So while breastfeeding is important, it’s not for everyone. So I’m telling you, OK, change your lifestyle, eat right and you have a brand-new baby. Really? You’ve got to be kidding. Your life just took a 180 anyway. So that is why we started looking at medical interventions even if they’re short-term. I’m not saying I want you on this the rest of your life. But short-term medical interventions that will help keep the weight off, give their pancreas a chance to recover and get healthier and kind of get things back to normal. What the research looks at is what is the best combination of medications that are the most effective in helping women. And all the medications we use are FDA-approved medications for diabetes. But we’re kind of using them for what we call pre-diabetes. So anybody with gestational diabetes is considered a pre-diabetic. So we’re kind of using the step before they actually become diabetic.
Have you come to any conclusions yet about those medications?
ELKIND-HIRSCH: The most commonly used medication is metformin. Everybody knows about metformin. They’ve all been on it. Many are on it even during pregnancy because it’s a very safe drug. It is somewhat effective but not as effective as some of the newer anti-diabetes medicines that have come out which are used for diabetics. They’re called the GLP-1s. There’s the SGLT2s. There’s the DPP-4s. We got a whole plethora of new medicines that all the work different ways on metabolism. And so certainly combinations like the DPP-4 and metformin or the metformin and the drugs like Victoza really work great together. But it’s interesting because everybody’s different. So while we can generalize and say some work; this one is probably the best one, it doesn’t initially mean it’s going to work for you. Like any medication, we try and we see if it works for you. But certainly we have some better medications now, particularly involving their ability to help you lose weight, which is really important post-partum. So they have that as their “side effect,” quote, which is kind of neat because in diabetes that’s been our problem as well. In diabetics, we don’t want them gaining weight, and a lot of our old drugs used to have them gain weight because they would make more insulin. These newer drugs help make your own insulin work better. So that’s how they work. It’s a little different.
Erica was a part of two studies. Can you kind of sum up those studies and what the main conclusion was?
ELKIND-HIRSCH: The first study she was in, which was an 18-month study where we looked at metformin alone with a placebo injection combined with a drug called Victoza, it was a combination where you took both. And Erica happened to be randomized to that combination therapy. We found that that was way superior in terms of weight loss, fixing the glucose and insulin than the metformin alone. And so one or both of the studies that I did involve women. They did have to be either overweight or obese to go in. So we didn’t look at normal-weight women. We only looked at women who were overweight, of course, postpartum and obese. So we can’t generalize it to the normal-weight female with GDM. The second study that she was involved in – and that was an injection. Some people have difficulty because you have to give yourself a shot every day. It’s a small needle. It’s like a little insulin pen. But some people have a hard time. They’re needle-phobic. There are now a bunch of new oral medicines, which, you know, sometimes you get better compliance. The one that she was in is – it’s called an SGLT2. And it was also with and without metformin. This one’s a little bit different. This one actually causes you to not resorb your sugar and you actually pee out extra sugar. And with that peeing out the sugar, which it lowers your sugar, lowers your insulin, you also put calories out. So weight loss is a side effect of that drug as well.
It’s really kind of neat because people don’t realize that insulin interacts in your cardiovascular system. Insulin makes the good cholesterol go down and the bad cholesterol go up. If you’re making a lot of insulin, so what if I fix that? Your HDLs go up; your triglycerides go down. So now actually these drugs are now being used by the cardiologists. Because they’re so effective in terms of cardiovascular disease.
The finding that gestational diabetes doesn’t just go away, was that part of your research as well?
ELKIND-HIRSCH: I always like to tell the story. So Joslin, who’s one of the fathers of diabetes – there’s Joslin clinic in Boston. Joslin actually described this in 1892. He had noticed he had a female who had diabetes during her pregnancy, and 12 years later, she developed full-blown diabetes. And he realized there was some association. The thing is there’s usually this large interval. Well, with our obesity epidemic, we have noticed that that window has now gotten very small. And in fact, we see about 70% of women, if they are not treated, converting from GBM to Type 2 diabetes within the first five years postpartum and largely due to not losing the weight and the fact that we have obesity. So we recognize now that that is obviously a precursor, but it really was described a long time ago. It’s pretty interesting. A lot of things were historically described, and all we do is keep repeating what was said in the 1800s.
So you almost rediscover it.
ELKIND-HIRSCH: Yeah. There was a lot of talk about that here. And one of the things I found was people were looking at conversion from gestational to Type 2. But we really didn’t have those numbers for our population. So I was luckily given a grant from the Baton Rouge Area Foundation and also the Pennington Family Foundation. When I started this in 2011, I just took a group of women who were post-gestational diabetes. And we did this to our glucose insulin test to just see what they looked like after they delivered. Some of them looked really bad, and we started them on medicine. But some of them didn’t look that bad. And then we talked to them about eating right, losing weight, not gaining weight. And then we had them come back a year later. So no medical intervention and then we did all the testing for free. And what I found was that in 50% of the African-American women, they had gotten a lot worse and converted. Some had converted to diabetes and some just what we call impaired glucose tolerance. They had become more dyglycemic. About 25% of our Caucasian women had done the same thing, and it was totally correlated with whether or not they had gained weight or lost weight. You could just draw the line. Those who gained the weight got bad. The ones who lost the weight looked much better. So that was a realization that we had to get that weight off. But just telling you to please get the weight off, I knew it was just really difficult.
There’s been what’s called the Diabetes Prevention trials that are looking 10 years out, and they looked at very intensive lifestyle intervention – metformin and I think just a placebo. And what they found is that, yes, that the lifestyle intervention worked really great. But actually in women who had GBM, the metformin was more effective.
Really?
ELKIND-HIRSCH: Yeah, and that’s a huge 10-year trial that the metformin probably has to do with. It was very difficult for women who had GDM to stick to this intensive – even though they were getting lots of coaching. I don’t think it’s a different disease. I just think that you have so many conflicts when you’ve got a newborn that it’s a very difficult time to really take care of yourself.
The rediscovery that GDM doesn’t just go away, did that happen here at Women’s?
ELKIND-HIRSCH: It’s kind of happened all over the country. One of the things that American Diabetes Association came out with and then the Endocrine Society and then finally American College came out with is the need to test women after they deliver and then follow them for the rest of their lives, to keep testing, doing the two-hour test that we did or when we do a three-hour when they’re pregnant – sometimes we do two – needed to be done even after they delivered. The problem is following those patients, getting them to come back in. You’re so involved when you’re pregnant. And then you get that baby, and you’re so involved that you forget about Mommy. And I really keep telling them, please, don’t forget about Mommy. It’s very difficult. Who’s going to follow you? What do I do? Who do I go to? Many young women don’t have an internal medicine doctor that would be the one they would be seeing. So that is why we set this clinic up, mainly for those patients. That was our initial development of the mobile clinic was for the postpartum GDM patient because they had no place to go. Their own OBs, this is not what you’re trained as a gynecologist to do. And then even they are not as familiar with a lot of these drugs. So we needed somebody who had that familiarity to follow these women.
Why do you think this research is even more important at this time and this day?
ELKIND-HIRSCH: Mainly because our diabetes incidence is skyrocketing and so is the health cost. So Louisiana is probably number one in diabetes in the country. I have watched our GDM rate go from 8% in 2011 to close to 13 or 14% in 2015.
That’s in Louisiana?
ELKIND-HIRSCH: Just in this hospital, looking at number of deliveries and number of women being coded for gestational diabetes. Now, remember we’ve been testing them for 15 years. So it’s not like we’re testing or we’re finding out now that people are gestational. We’re always testing them.
It’s not tied to more tests.
ELKIND-HIRSCH: It’s not tied to more tests. It’s tied to the fact that people are larger, and young people are larger. And that’s going to be a stressor. Diabetes is also genetic. Mom had diabetes. You have the gene for diabetes. You can’t change the genes. We can change our environment. We just can’t change our genes. I tell people that every day. Can’t change your genes, not yet. We’re getting there. We’re starting to do that, but that makes me scared.
How does it make you feel to be a part of this?
ELKIND-HIRSCH: Sometimes I’m excited because people get it. I love to watch people understand. I think that everybody at every educational level can understand what I’m telling them. It’s really just a matter how you explain it to them and why this is happening. So I think some people say, oh, people don’t get it. Everybody gets it. And whether you’re well-educated, you’re high school – it doesn’t matter. There’s a famous saying from Einstein. It’s my favorite saying that is if you can’t explain it to an 8-year-old, then you don’t understand it. And that’s the way I feel. I mean, that’s the way I was taught. And I can talk at this level, or I can talk at this level. But I think everybody can understand it. I think if we empower people, they will take care of themselves. But we’ve got to get the message out there that they’re at risk and I think people even don’t realize they’re at such risk. So that’s where I think where we’re falling down. So that’s one of the things we really want to do.
Maybe you can expand upon about how six months of intervention can change the entire person’s life?
ELKIND-HIRSCH: Some people ask, how long is this for? Well, it is for the rest of your life. You’re at risk. Even some of the interventions like the second study was only a 24-week intervention, and we already saw significant improvement in a huge cohort of these patients – so the fact that we can even medically intervene for six months and change the course of the disease. Some of these patients had already become impaired, meaning you’re not diabetic, but you’re not normal. You’re kind of in that gray zone going the wrong way. And we shifted them all back into the normal range within that very short window of time with the medicine. So that’s exciting that we can fix the sugars that fast because their pancreas is still healthy. See, if we wait till they become diabetic, it’s always really hard to go backwards in time.
I feel like we just don’t do enough stories about preventative care.
ELKIND-HIRSCH: We do not do health care. We do disease care. That is our problem. We don’t do health care. There is a wonderful physician, Dr. DeFranzo, who is one of the fathers in diabetes. And Ralph has taught me lots. But he is always, like, we need to get companies, we need to get drugs on board before you become diabetic. If we treat the pre-diabetic, we’re going to be so much more successful than if we wait until they become a diabetic. And he’s at every diabetes meeting.
What are your concerns of doctors who are not using this procedure?
ELKIND-HIRSCH: Who aren’t testing their patients. So that’s a big problem. The bottom line is that what happens in many of these patients is they’ll come back to see you when they’re pregnant again. And now their gestational diabetes can’t even be controlled by oral medicine. Many of them have to go on insulin. Again, that’s another clue if you have to be controlled by insulin during your pregnancy, you’re in a worse place than somebody who can just control their diabetes by diet.
For many of these patients, they’re going to be diabetic when they come back. So then you’re managing now a high-risk pregnancy, which puts the onus on our high-risk doctors. And it just makes it hard for baby and for mommy.
For the studies, who funded them?
ELKIND-HIRSCH: So each study was funded by a different pharmaceutical company. I get a lot of funding. So one of the difference is with these studies, they’re called investigator-initiated trials, meaning the drug company doesn’t come to me and say, I want you to study this. We write up protocols based on our practice or what questions we want to ask with these medications. And we go to them, and they have sort of competitive grants. What’s really nice is basically they are hands-off the studies. They provide all the medications. They provide funding so that it’s free to the patients. They pay for all the testing. But I provide them with the information. And of course I acknowledge them for the fact that they supported that. All of these are independent investigator. These are not grants that were given because the company was asking that question. Now, sometimes it’s nice when the company does ask a question and we develop multi-center – like some of these would be great if we could go on to become a multi-center – and look at it in different populations. Our population is mainly Caucasian and African-American, where there’s Hispanic in Texas or there’s Asian out in California. So doing multi-centers, you get to look at different ethnicities, too, which plays a part.
And are you directly or indirectly compensated by the manufacturer of the drugs?
ELKIND-HIRSCH: So, no. So basically, yes, there is moneys paid to Women’s Hospital for the trial, overhead and stuff. And there’s moneys built into there for my salary, although, they don’t pay me. They pay the hospital, and the hospital pays my salary. So just to pay for my staff because we’re dedicating a lot of time.
So they provide the medications and budget.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
If you would like more information, please contact:
Caroline Isemann
514-909-8359
Sign up for a free weekly e-mail on Medical Breakthroughs called First to Know by clicking here
