By Liz Szabo, USA TODAY
CHICAGO - Obesity surgery can reverse the signs of diabetes, according to small new study, allowing many patients to quickly reach normal blood-sugar levels while reducing or eliminating their need for insulin or other medications.
In the study of 150 patients with Type 2 diabetes, 42% of those randomly assigned to the stomach-reducing surgery saw their blood sugar drop to normal levels, according to research presented in Chicago at the annual meeting of ithe American College of Cardiology. Some patients who had the operations, called bariatric surgery, improved so rapidly that they went off their diabetes medications before leaving the hospital, says lead investigator Philip Schauer, a professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic.
Improving blood sugar is vital, because patients in the study had suffered from "uncontrolled" diabetes for eight years or more, in spite of seeing their doctors regularly, says co-author Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. High blood sugar increases the risk of diabetic complications, such as heart attacks, kidney failure, amputations and blindness. Patients began the study with very high blood sugar, as measured by a test called hemoglobin A1c, or HA1c. Patients' average baseline HA1c levels were 9.2%; a level of 6% or lower is considered healthy. After surgery, nearly half reached about that level.
"The result is simply stunning," Nissen says. Nissen says he's reluctant to say that the operation, known as bariatric surgery, actually cured diabetes, because patients have been followed only for one year. "But from a biochemical point of view, they were no longer diabetic."
Patients agreed to let researchers randomly assign them to one of three treatments, according to the study, published in the New England Journal of Medicine. One-third received intensive therapy with multiple drugs, plus counseling and lifestyle changes; one-third received medications plus underwent "sleeve gastrectomy" surgery to remove up to 80% of the stomach; one-third got medications and had a more extensive surgery called gastric bypass, which reduces the stomach to 2% to 3% of its former size, then reconnects it to the small intestine.
Patients treated with intensive medications, who saw their doctors every three months, also improved, but not as much. About 12% achieved a normal blood sugar, the study says.
Heather Britton, 53, says she's 73 pounds lighter today than when she had a gastric bypass during the study, three years ago. She describes her diabetes as "in remission." She was able to go off all of her medications - for diabetes, high blood pressure and high cholesterol - within three months of surgery, and no longer suffers from asthma or food allergies. Britton is no longer able to eat fatty foods, such as ice cream or peanut butter, which make her feel sick. But she's exercising regularly and feels better than ever. "It's been wonderful," says Britton, of Bay Village, Ohio, who has lost several family members to diabetes. "It's changed my destiny."
Yet surgery poses risks, Schauer says. The most common complications in the study were dehydration and bleeding. One patient developed a gastrointestinal leak from the surgical site. That's a serious issue, because it can lead to a dangerous infection. Four of 100 surgical patients needed additional surgeries to fix these complications within a year of their operation. No one died or suffered a life-threatening or debilitating complication.
Patients treated at community hospitals may not achieve the same results as those treated at the Cleveland Clinic, a top-tier center, says Brian Sabowitz, a bariatric medicine specialist in San Antonio. He advises patients to look for a surgeon who performs at least 150 bariatric surgeries a year. In general, about 15% to 20% of patients undergoing these procedures suffer a complication, such as nausea or needing intravenous fluids, although only 1% suffer a serious complication. The death rate from the surgery is 1 in 2,000.
Researchers plan to follow patients for three to four years to see how long such "remissions" last. They will also compare the long-term costs of the three approaches. Surgery can cost $25,000 and may not be covered by insurance, Schauer says. Years of treatment with drugs can be expensive, as well. Patients whose diabetes isn't controlled may need surgery or other expensive, invasive procedures, such as kidney dialysis, Nissen says.
On average, patients began the study with a body mass index, or BMI, of 36. A BMI of 25 to 30 is considered overweight, while above 30 is obese, according to the National Heart, Lung and Blood Institute. Surgical patients lost about 60 pounds, with a post-treatment BMI of about 26, close to their goal weight, Schauer says.
The study was primarily funded by Ethicon Endo-Surgery, a surgical device maker.
Doctors can't explain why surgery had an almost immediate effect on patients' blood sugar and hormone levels, says co-author Sangeeta Kashyap. But the study suggests a key role for hormones made by the digestive tract. She notes that overweight people often stop making important hormones that help regulate insulin.
"We used to think the pancreas was dead" when people with Type 2 diabetes had to start taking insulin, Kashyap says. "The fact that they were able to stop their insulin says we were able to get their pancreas to start working again. Their pancreas was waking up and revitalized."
Sabowitz says he has seen results like these first-hand. The fact that diabetes resolves so quickly, he says, suggests that surgery has effects that go beyond weight loss or simply discouraging patients from eating.
Still, Sabowitz says he'd like to see longer-term data. He says bypass patients often regain 15% to 20% of their initial weight loss about 18 months or so after surgery, as their body adjusts and compensates for the anatomical changes. He never has seen bypass patients regain all their weight, however.