Nejm Article Shows Bariatric Surgery (Bypass And Sleeve) Helps Control Diabetes Better Than Medicine Alone

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Bariatric surgery helps control diabetes, Cleveland Clinic researchers find

Published: Monday, March 26, 2012, 11:32 AM

CLEVELAND, Ohio -- Cleveland Clinic researchers have traveled to Chicago to present to a large gathering of cardiologists a ground-breaking study that shows bariatric surgery is more effective in treating people with Type 2 diabetes than medication alone.

The study, being published today in the New England Journal of Medicine, is one of two studies in the journal documenting the advantage of bariatric surgery to control diabetes. The results of a separate clinical trial that documents similar advantages, but over a two-year period, come from the Universita Cattolic+ de Sacro Cuore in Rome.

The Clinic's study shows one-year results from its trial, Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE).

"This is a radical concept," said Dr. Philip Schauer, a surgeon and director of the Clinic's Bariatric and Metabolic Institute who is the primary author of the study. "We're taking a medical disease treated by medication and we're saying that surgery in some patients is more effective."

A few days before the start of the annual meeting of the American College of Cardiology, Schauer said, "I expect a very interesting conversation."

"Medical therapy is always targeted to slow down advances of the disease," said Dr. Sangeeta Kashyap, an endocrinologist in the Clinic's Endocrinology and Metabolism Institute. "Here's something we found that could potentially reverse the disease and maybe stop it in its tracks. That is going to catch the attention of the medical community."

For the past 20 years, physicians have used bariatric surgery as a treatment for morbid obesity. More recently, physicians have turned to the weight-loss surgery to treat diabetes in people who were moderately and severely obese.

Not everyone in the medical establishment has embraced surgery as a treatment option. Many have been hesitant to endorse bariatric surgery because it hadn't been compared head-to-head in a randomized trial with some of the newer, more effective drugs used to treat diabetes.

"Frankly, there have been endocrinologists who argue that [they] can achieve the same effect with drugs, with much lower risk," Schauer said.

In 2007, physicians from the Clinic's departments of endocrinology, bariatric surgery and cardiology -- diabetes increases a person's risk for heart disease -- collaborated on a clinical trial to compare, for the first time, two types of bariatric surgery against intensive medical therapy alone.

"We've known [anecdotally] that it seemed like people with diabetes and obesity who got bariatric surgery got significantly better [than with] intense medical therapy," said Dr. Steven Nissen, chairman of cardiovascular medicine at the Clinic.

But what was lacking was concrete evidence to support those anecdotes, he said.

The STAMPEDE study is important because it offers such evidence, says Dr. Paul Zimmet, director of International Research at Baker IDI Heart and Diabetes Institute in Melbourne, Australia, who co-wrote an editorial in NEJM that accompanied the Clinic's study.

"Type 2 diabetes is the biggest epidemic in human history," he said. "Bariatric surgery will not be the answer as a public health strategy, but there are groups of patients who have failed the standard medical therapy," Zimmet said. "A change in the paradigm should be that bariatric surgery should be considered earlier, rather than as a last resort."

Who took part in the study

Between March 2007 and January 2011, the Clinic physicians screened 218 patients from Northeast Ohio for the trial. Apart from advertising the study in The Plain Dealer and other publications within a seven-county area, the researchers asked other physicians for recommendations and identified other potential subjects through electronic medical records, Schauer said.

Trial Treatments

Here are the three treatment methods studied in the STAMPEDE trial at the Cleveland Clinic:

• Gastric bypass. In this type of bariatric surgery, physicians bypass 95 percent of a patient's stomach and duodenum, part of the small intestine connected to the stomach, so that the stomach volume shrinks from the size approximate to an inflated football, to a golf ball. This operation has been common for many years. Four patients in the STAMPEDE trial had to have repeat surgery.

• Sleeve gastrectomy. This is the most rapidly-growing procedure throughout the world, says Dr. Philip Schauer, director of the Clinic's Bariatric and Metabolic Institute. The surgery reduces stomach volume by about 80 percent, shrinking the stomach from the approximate size of a fully-inflated football to the size of a banana. A specialized mini-stapler is used vertically along the stomach, removing more than two-thirds of the stomach itself. There is no intestinal bypass.

• Intensive medical therapy, which includes a change in diet as well as medications such as insulin.

The Cleveland Clinic study focused on patients who, because of their size, otherwise would not be candidates for bariatric surgery. Typically the surgery isn't an option unless someone is more than 100 pounds over their ideal body weight (a body mass index of about 40 or higher) or -- for those with conditions such as high blood pressure or diabetes -- a BMI of 35 or more.

The target patient was between 20 and 60 years old with a BMI between 27-42, poorly controlled diabetes that had been diagnosed more than nine years earlier and a blood sugar level that when measured with a hemaglobin A1c test over a three-month time was more than 9 percent. The blood sugar level for non-diabetic patients is 6.1 percent or less.

"The success rate for each group is not just achieving a good blood sugar, but a normal blood sugar," Schauer said. "We wanted to know what percentage of patients after one year were able to reach that target."

The answer: 42 percent of gastric bypass patients were able to reach that non-diabetic level, while 37 percent of patients who underwent sleeve gastrectomy were able to do so. Only 12 percent of patients whose treatment was solely intensive medical therapy were able to reach that non-diabetic level.

"This is really an extraordinary result. We always thought of diabetes as an inexorable disease," Schauer said. "The very idea that you could take advanced diabetics and return them to normal blood sugar on no medications . . . 78 percent of gastric bypass patients were on no drugs at the end of the study."

It is an important outcome, he said, because in many patients, "drugs gradually fail."

The only other study to date that conducted a head-to-head comparison of medical therapy to bariatric surgery to treat Type 2 diabetes was conducted by researchers in Australia. The study, involving 60 patients who were followed for two years after receiving either laparoscopic adjustable gastric banding surgery or medical therapy, appeared in the January 2008 issue of the Journal of the American Medical Association.

"These new studies are timely," said Zimmet, one of four co-chairs of a consensus meeting convened in 2011 by the International Diabetes Federation Taskforce on Epidemiology and Prevention of Diabetes that looked at the role of bariatric surgery in the treatment of Type 2 diabetes.

"It seems to me better later than never."

Many of the people who agreed to be screened for the trial already had secondary complications such as retinopathy (damage to the retina) and early signs of kidney impairment.

Before they could participate in the study, prospective patients had to agree to go through any of the three treatments they were randomly chosen for.

The reaction among patients who were contacted?

"Mostly hesitation," Schauer said. "This is the reason it's taken 20 years to do this kind of study. Most people, they don't think of surgery to treat diabetes. For 100 years, diabetes has been treated the same way -- with pills and injections. The perception of surgery was that it was very dangerous and had super high risks."

Bariatric surgery carries with it the risks of any major surgery, along with more specific risks such as abdominal hernias, bowel obstruction and stomach perforation, according to information from the Clinic's Bariatric and Metabolic Institute.

Type 2 diabetes also comes with its own risks, potentially affecting the heart, kidneys, eyes and virtually every major system of the body.

The trial components

Researchers narrowed the pool down to 150 patients. Thirty-six people were African American, a population disproportionately affected by diabetes. Forty-four percent of patients were on insulin at the time they enrolled. All but 10 of the 150 patients completed their assigned treatment and one-year follow-up.

Every patient enrolled saw a nutritionist who crafted a diet that they would follow if they were assigned the surgery. Patients also underwent psychological screening and saw an endocrinologist, a physician who specializes in treating diabetes, every three months. All of the patients received intensive medical therapy above and beyond what is recommended by the American Diabetes Association.

HEATHER-BRITTON-BEFORE-SURGERY-DIABETES.JPGView full sizeCourtesy Heather Britton"This is a chance for other people to learn that there is hope for diabetes," says Heather Britton, shown here in 2008 before she had bariatric surgery.

Following a couple months of appointments, tests and evaluations, Heather Britton of Bay Village found out in late 2008 that she qualified for the Clinic study and would be getting gastric bypass.

"I was in total shock," she said. "I was very nervous, very anxious."

Before her January 2009 operation, Britton, 53, had been taking a half dozen medications (but not insulin) to regulate her diabetes as well as her blood pressure, triglyceride and cholesterol levels, and an using an inhaler for her allergies.

Following the surgery, Britton lost 80 pounds. She gained some of the weight back when she started reintroducing some foods to her diet, but says that today she is "still in very good shape." By May 2009, Britton was no longer on any medication, but now takes Vitamins and supplements.< /p>

"Not only did they come off of their diabetes medication, but they came off many other medications [such as those] for cholesterol and hypertension," Nissen said of the surgery patients. "They went from taking a boatload of medications every day to none or few medications."

"Truthfully, I never would have done [the surgery]," said Britton, who had known other people who had gastric bypass surgery. She just never made the connection between the surgery and a treatment for diabetes.

"The reason I did it, though, was because it was very important to me to help other diabetics and to help my family," said Britton, who has a family history of the disease. When Britton received a letter in the mail in September 2008 inviting her to be part of the study, she thought it was a joke at first.

But the letter came with a detailed questionnaire. She had been wanting to do something for a while that would make her healthier, so she filled it out.

"That was really important to me," said Britton, who was diagnosed with diabetes in her early 40s and who had a strong family history of the disease.

"This is a chance for other people to learn that there is hope for diabetes," said Britton, who, like the other study participants, is being monitored with follow-up visits for five years. "It has changed and redirected the health history for myself and my family."

Everyone diagnosed with diabetes should be educated about all treatment options, Kashyap said.

"This is not happening around the country," she said. "They're not told anything about lifestyle [changes]. For those who simply aren't responding to medication, then I think it's important to talk about surgery. They will always need medical therapy follow-up.

"I tell my diabetic patients, 'You are now diet-controlled,' " she said. "Endocrinologists and surgeons are going to have to work together to identify the best candidates [for surgery]."

What is the next step in terms of the research?

"We're going to follow folks longer, look at the durability of surgical effect," Schauer said. "Our expectation is that the progress will continue."Already a follow-up study is tracking a subset of the patients who had surgery to see how they're doing, said Schauer, who said he hopes to have some initial data available later this year.