Medical Device Daily Executive Editor

SAN DIEGO – One of the most intriguing sessions of this week’s annual meeting of the American Diabetes Association (ADA; Alexandria, Virginia) – largely because of the unexpected nature of its subject – saw a variety of clinicians address the value of gastric bypass on diabetes patients.

The case study-based session at the San Diego Conference Center Monday afternoon posed the question “Gastric Bypass: A Quick Cure for Diabetes?”

The most enthusiastic advocate of this strategy was Philip Schauer, MD, director of abdominal laparoscopic and gastric surgery at the Cleveland Clinic Foundation, who expressed a certain measure of amazement that the session even had made it onto the ADA program.

He noted, for instance, that the Standard of Medical Care for Diabetes, which includes the association among its primary developers, “makes no mention of bariatric surgery.”

But, lo and behold, said Schauer, along came the February 2005 issue of the journal Diabetes Care with an article headlined “Who’d Have Thought It? A Surgical Treatment for Diabetes.”

Discussing the existing standard of medical management (oral agents and insulin) of the disease, he declared: “We haven’t altered the natural history of this disease in 100 years.”

Schauer provided his audience with a run-through of the medical literature covering different types of gastric bypass surgery, noting in particular their success in bringing a “resolution” to diabetes among a significant proportion of obese patients who undergo such surgery.

He cited a report by noted gastric surgeon W.J. Pories, MD, which appeared in the Annals of Surgery a decade ago, citing an 83% diabetes resolution rate for Type 2 diabetics who had undergone such surgery.

And Schauer lamented that “unfortunately, only surgeons saw that report,” implying that its effectiveness would have been enhanced had it appeared in a journal directed toward endocrinologists and other “diabeticians.”

Another well-known surgeon, Harvey Sugarman, MD, found a nearly identical rate of resolution for Type 2 patients, although he reported that older patients had outcomes that were not quite as successful.

Schauer said that in his own experience, largely when affiliated with the University of Pittsburgh Medical Center prior to moving to his present post in Cleveland, he found that 82% of obese Type 2 diabetics who underwent gastric bypass reached resolution of the disease, while the blood glucose readings and other diabetes measurements for the remaining 18% were “much improved.”

He said the study looked at the duration and severity of Type 2 diabetes in 191 patients. The weight loss experienced by those who underwent gastric bypass was “very good,” he said, adding that the results were “fairly durable over a five-year period.”

As for A1c readings – the test that measures average blood glucose over a two- to three-month period – Schauer said that “dramatic decreases” in weight were recorded after surgery.

He noted that those patients who had “less severe disease at the time of surgery [also] had the most dramatic improvement,” as did those who had had Type 2 diabetes for a shorter time. The patients had an 84% reduction in the use of oral agents after having their surgery, with 30% of patients discontinuing all medications upon discharge from the hospital – “a pretty dramatic effect within days of surgery.”

And, he said, “during five years, no patients got worse [insofar as level of blood glucose was concerned] and no patients developed diabetes.”

Schauer cited still another study, this one conducted by Italian researchers, which showed “significant improvements” in pre-diabetes or very early diabetes patients who underwent laparoscopic adjustable gastric banding surgery, with 55% resolution of diabetes at one year, 79% at two years and 84% at three years.

He also described the 10-year outcomes data from the Swedish Obesity Subject (SOS) study, which compared what Schauer termed “the most comprehensive medical management” to all forms of gastric bypass surgery.

“There were significant differences at 10 years in weight loss, blood glucose, blood pressure and insulin use,” he said. All forms of surgical procedures together showed a 72% resolution of diabetes at 10 years, Schauer said.

He also cited a bariatric surgery “meta analysis” reported in the Journal of the American Medical Association in late 2004, which showed a 76% resolution of diabetes and an 86% improvement in A1c readings.

Acknowledging that gastric bypass procedures have risks, he said that endocrinologists and other diabetes practitioners “have to consider that in your strategy” of helping patients deal with the disease.

Since surgical therapy “is not even on the map in your standard of treatment,” Schauer offered this suggestion: “Let’s get surgical treatment into the program of care as a possible means of resolving diabetes.”

That, he said, might help change the definition of diabetes as a disease for which there is not yet a cure. “Perhaps surgery is as close to a cure as we can possibly get,” said Schauer.

Responding to a question from the audience about gastric surgery being limited to those with a body mass index (BMI) of 35 or higher, he said, “Unfortunately, insurance carriers will only cover gastric bypass procedures for severely obese patients under those BMI guidelines.”

He did predict, however, that would eventually change, with those with lower BMIs becoming eligible for such insurance coverage.

After an endocrinologist urged Schauer to “talk with your [surgical] colleagues about increasing their follow-up and publication of outcomes” on bariatric surgery, he nodded his agreement. He said that the rapidly growing specialty – which has increased 10-fold in the past five years – needs more centers of excellence, and more gathering and publication of long-term outcomes.

To diabeticians who might refer their patients for gastric bypass surgery, he said, “make sure your surgeon is experienced and has a record of outcomes.”