Philip Schauer, M.D., director of the Cleveland Clinic Bariatric and Metabolic Institute, Cleveland, Ohio, discusses the benefits of bariatric surgery for those with diabetes.
Interview conducted by Ivanhoe Broadcast News in May 2017.
Why did you decide to do STAMPEDE?
Dr. Schauer: Yeah, well STAMPEDE is a randomized control trial comparing two types of surgery. Two types of bariatric procedures compared to medical therapy, intense medical therapy for treating Type II diabetes. We have known for many years that bariatric operations can cause weight loss, but it turns out that for those who have diabetes, the diabetes goes away. In this study we wanted to compare head to head the impact of surgery versus very intense medical therapy. Not just the standard medical treatment, but intensive medical treatment. The goal was to see which of these therapies had the best outcomes in terms of reducing blood sugar to as normal level as possible. Normal glucose levels (HbA1c < 6%), you could say, would be a cure or remission of diabetes, so that was the goal of the study. The two procedures included the two most common bariatric procedures; the gastric bypass and sleeve gastrectomy. The sleeve gastrectomy is a simpler procedure. We’re taking the stomach, which is about the size of a football, and we’re reducing it down to the size of a banana, so reducing the volume by seventy five to eighty percent. We’re actually removing part of the stomach. The gastric bypass, which is the other common procedure, has actually been around a bit longer, about thirty years. That procedure, we’re reducing the stomach from the size of a football down to about the size of an egg or a golf ball. Unlike the sleeve gastrectomy, we’re actually bypassing part of the intestines. We’re bypassing the remainder of the stomach ie. the ninety percent of the stomach that’s left behind and a small portion of the intestines. So the gastric bypass has an additional weight loss affect compared to the sleeve gastrectomy. Those are the two procedures that were utilized in this STAMPEDE trial. There were a hundred and fifty patients in the study and we followed them for five years. Results were published this most recent publication in the New England Journal of Medicine in February of this year. Basically, the patients that had surgery had a much greater improvement in their blood sugar over the five years, compared to the patients who were treated with just medications alone. There was a substantial difference in glycemic control favoring surgery. In fact, nearly one quarter of the patients who had the gastric bypass actually were in a complete remission of their diabetes for five years. That is they were able to achieve normal blood sugar requiring no medications at all, which is pretty remarkable. That’s about as close to a cure as you can get. With the intensive medical therapy glycemic improvement was much less compared to surgery. In addition, patients who had surgery also reported a much better quality of life. There were complications with the medical treatment and with surgery, fortunately nobody died from surgery in the study. There were a few surgical complications, about eight percent of the patients required another procedure within five years, but there were no severe disabling complications of surgery. There were also side effects on the medical side, side effects of the medications; weight gain issues, but all in all the patients who had surgery actually did better and were happier at the five year mark compared to the patients who had medical treatment only. One of the other major benefits of surgery was the ability to wean patients off insulin. About half of the patients were initially on insulin which is fairly debilitating in terms of quality of life. You have to inject yourself several times a day; you have to check your blood sugars constantly for fear of your blood sugar going to low. We found that those who had surgery, a very high percent, were able to come off insulin completely, which was a big advantage of surgery over medical therapy.
Do the benefits of doing gastric bypass or bariatric surgery in general outweigh the cost of doing the procedure?
Dr. Schauer: Correct. There have been several studies that have evaluated the cost of surgery and on average the procedures will cost around twenty five thousand dollars. But when you consider the amount of money that is saved in reducing the medication requirements and reducing the number of doctor visits that are required, studies have suggested that these operations are very cost effective. They might even be what we call cost savings. A few studies have shown that within about five to seven years of having the surgery, the actual cost of surgery is recouped based on the savings from reduced medication costs.
Would you consider bariatric surgery a last resort to control diabetes?
Dr. Schauer: Bariatric surgery should be considered another powerful tool for patients and for physicians to consider, but it’s rarely the first option. The first option is always lifestyle management such as diet and exercise. Unfortunately that by itself is not effective for most people. The next therapy is medications; there are some very good medications out there including insulin and other drugs for diabetes that are effective. But unfortunately, even that is not effective for everybody. So surgery is another powerful tool for those people who have Type II diabetes and obesity; which is the majority of patients with diabetes. Surgery is another very powerful tool to help the patient and the doctor meet these important goals of therapy. These are good blood sugar control, good control of blood pressure, control of cholesterol as well and control of obesity. Surgery can positively affect all of those. We didn’t talk too much about that before we were focusing on blood sugar, but surgery can also help with blood pressure and cholesterol and other important lipids and of course weight. Surgery impacts all of those areas, so it can be a very important, safe tool for the patients to consider, particularly those who are not responding well to medications and diet and exercise alone.
Could you describe the perfect patient with diabetes who would benefit most from bariatric surgery?
Dr. Schauer: The patient who would benefit the most from bariatric surgery would be a patient who is obese or overweight with a body mass index of thirty or greater, who is already on medications and not in good glycemic control despite medication. Patients who are about to consider insulin are particularly good candidates. Most patients will start on some oral medications, two or three perhaps, and if those don’t work they jump to insulin. Unfortunately, once a patient jumps to insulin they’re usually on it for the rest of their life. Insulin has side effects such as weight gain and other side effects that are not so good. Also it dramatically affects life style. Patients have to inject themselves usually more than once or twice a day. They have to monitor their blood sugar even more closely, so they’re constantly monitoring their blood sugar. It does critically impact ones day to day living and routine, so surgery could be a way to enable a person to have very well controlled blood sugar without requiring insulin the rest of their life. Surgery enables the possibility of eliminating the other medications that they’re on, causing weight loss, improving their blood pressure and their cholesterol. With one intervention, you get a lot of improvement. We found that our patients, who had surgery in the STAMPEDE trial, had a much better quality of life than the patients who did not.
Why do you believe that gastric bypass or bariatric surgery works so well compared to other methods when it comes to controlling diabetes long-term?
Dr. Schauer: Well we know that one benefit of surgery is the incredibly weight loss that patients receive. It’s not unusual for patients to lose eighty pounds, a hundred pounds depending upon how overweight they are. Anybody who has Type II diabetes and loses weight, their diabetes gets better. The problem with diet and exercise is usually the amount of weight loss is very modest and it doesn’t last very long. So nothing beats surgery in terms of the amount of weight loss and the durability of the weight loss. The weight loss itself is helpful. But we know that there’s other benefits of surgery in addition to the weight loss that affects the diabetes, especially for the gastric bypass. It seems to be a result of the way we bypass the intestines. It appears that there are some special hormones made in the intestines that are significantly increased after the gastric bypass. These hormones have a direct effect on the pancreas and the cells that make insulin, the beta cells. By bypassing the intestines we get a boost in these hormones that make the beta cells produce insulin more effectively. Patients are using their own insulin better than having to rely on giving themselves insulin shots.
Is there a correlation between the amount of weight loss and how quickly someone is able to better control diabetes?
Dr. Schauer: One of the remarkable and interesting things about these procedures is that we often see very dramatic and quick improvements in blood sugar. It’s not unusual for my patients to come in the hospital before surgery on a hundred units of insulin then within two days of leaving the hospital, they are on zero insulin. That’s even before they’ve really lost any amount of weight, because the weight loss takes months and months to gradually come off. Therefore, this speaks to this other effect of surgery that’s independent of the weight loss. That happens very rapidly. It’s pretty amazing to see this happen in front of one’s eyes, particularly in patients who are so dependent on insulin and other drugs to keep their blood sugar under control.
What are some of the dangers and risks of the surgery people should know about?
Dr. Schauer: Well one of the remarkable advances in surgery in the past ten to twenty years has been the introduction of minimally invasive or laparoscopic surgery. That is the idea of performing major abdominal surgery through very small incisions, laparoscopic. Just like the gallbladder surgery. Bariatric surgery now is almost always done with laparoscopic techniques, which dramatically reduces pain, and the hospital stay is typically one or two days. Patients are back to work pretty quickly, usually around two weeks, there’s very rapid recovery. The overall complications have dramatically decreased with laparoscopic surgery. So much so that both the sleeve gastrectomy and the gastric bypass have complication profiles very similar to gallbladder surgery which is considered very safe. Other comparables would be appendectomy, hysterectomy, cesarean section; these are all considered relatively low risk abdominal procedures. Much lower risk than for example, heart bypass surgery, which is about ten times higher risk. Even surgery to remove part of the bowel, the colon, that’s about three or four times higher risk than bariatric surgery. Consequently, there’s been a dramatic improvement in the immediate surgical risks, things like bleeding, infection; blood clots have dropped quite dramatically with less invasive surgery.
Are there other benefits of doing gastric bypass besides weight loss and diabetes management?
Dr. Schauer: In addition to the remarkable improvement in blood sugar after gastric bypass, the sleeve gastrectomy we also see benefits in terms of improving hypertension, improving cholesterol and other lipids like triglycerides. HDL cholesterol, LDL cholesterol those all improve after surgery. Then of course dramatic weight loss as well. So blood sugar, blood pressure, cholesterol, weight loss, all four of those conditions are dramatically improved fairly rapidly after these procedures, unlike medications. For each of those conditions, you often have to take one or two medications per condition. If you have high blood pressure it’s often two pills for that. If you have diabetes then you have to take two or three pills and sometimes insulin for blood sugar contol. For cholesterol, another one or two pills is required. So for patients that have all these conditions, it’s not unusual to be on five, six, seven, eight drugs in one day which is pretty remarkable. Add to that insulin injections or checking your blood sugar two, three or four times a day; it’s a heavy burden on any patient. One huge advantage of surgery is reducing that burden, getting patients off those medications and at the same time improving all of those conditions.
What are some other ways people can control their diabetes without the need for insulin?
Dr. Schauer: Other ways to control diabetes without insulin, you’d have to go back to the other two major strategies including lifestyle which is diet and exercise and then other medications. Now there are some newer medications on the market, some of them are injectable like insulin, some of them are oral agents, and it usually does require multiple medications. Patients would typically be on two, three, or four pills to try and avoid having to take insulin. Those are the main options.
What are the three most important questions people should ask their doctors before having bariatric surgery?
Dr. Schauer: I think the three questions are number one, will the surgery significantly improve my diabetes and reduce my risk of having long-term complications of diabetes like heart attack, stroke, blindness, kidney failure. Number two, is the surgery safe, what are the chances of me having a complication, a severe complication of surgery. Then number three, what is the cost of surgery or in other words will my insurance cover the surgery. Those are the three critical questions.
After having the procedure done, are there common mistakes patients make that could be avoided?
Dr. Schauer: After surgery it’s very important that patients have regular follow-up. Particularly in the first year as they are losing weight, and as their diabetes is improving they need to be monitored to reduce their medications appropriately. That first year is very intense and then even after that first year, it’s recommended they have at least a follow-up once a year with their bariatric surgeon to ensure that their nutrition is good and to be sure that patients take their prescribed vitamins on a regular basis. If they don’t, then they get in trouble. They can develop some nutritional deficiencies; most common would be anemia which is related to iron deficiency so it’s very important that they take their vitamins routinely. Also, routine, daily exercise is essential. We strongly encourage daily exercise, about thirty minutes a day. This is good whether a person has surgery or not. This is just very, very important for all of us to do. And make good eating choices. We spend a lot or time with our patients as most bariatric surgeons do, in counseling patients on how to eat after surgery and making good food choices. Particularly food that is high in protein. One doesn’t necessarily have to follow a strict diet per say, but has to have good food choices. The way this surgery works it reduces the appetite quite dramatically so patients need to make good food choices. Common mistakes would be for patients not to be so compliant taking their vitamins, not exercising like they should be, or perhaps not making healthy food choices.
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.
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