News and Trends April 2012

| April 16, 2012

CLEVELAND CLINIC STUDY SHOWS BARIATRIC SURGERY IMPROVES, REVERSES DIABETESSignificant Decreases in Blood Sugar May Lead to Fewer Medications
CLEVELAND, Ohio (Cleveland Clinic)—Overweight, diabetic patients who underwent bariatric surgery achieved significant improvement or remission of their diabetes, according to new research from Cleveland Clinic.

In a randomized, controlled trial, some weight loss surgery patients achieved normal blood sugar levels without use of any diabetes medications. In others, the need for insulin to control blood sugar was eliminated. Recent observational studies had demonstrated that bariatric surgical procedures reduce the incidence of type 2 diabetes (T2D) and lead to substantial improvement for many patients with pre-existing disease.

“After one year, patients who underwent gastric bypass or sleeve gastrectomy lost more weight and were significantly more successful at controlling their diabetes, compared to those who simply took medications,” said lead investigator Philip Schauer, MD, Director of the Cleveland Clinic Bariatric and Metabolic Institute. “We believe that bariatric surgery represents a potentially valuable strategy for control of diabetes that should be considered in more patients who do not respond to conventional treatment.”

Results of the STAMPEDE (Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently) trial were published in The New England Journal of Medicine and presented at the Annual Scientific Sessions of the American College of Cardiology in Chicago, Illinois.

The STAMPEDE trial involved 150 patients with obesity and poorly controlled diabetes. The patients were divided into three groups of 50: those who received intensive medical therapy of their diabetes, those who received intensive medical therapy plus gastric bypass surgery, and those who received intensive medical therapy plus sleeve gastrectomy.

“This trial demonstrates that bariatric surgery can eliminate the need for diabetes medications in many obese patients whose diabetes is poorly controlled,” Schauer said. “Furthermore, the surgical patients showed major improvements in other measures of heart health, including reduced need for high blood pressure and cholesterol medications, while significantly boosting HDL—the so-called ‘good’ – cholesterol.”

Effectiveness was gauged by the percentage of patients who achieved an average blood sugar within the normal range 12 months after treatment (measured using the hemoglobin A1c – HbA1c – a standard laboratory test that reflects average blood sugar over three months).

After 12 months, a normal HbA1c (less than 6.0) was achieved in 42.6 percent of patients who underwent gastric bypass and 36.7 percent of patients who underwent sleeve surgery, but just 12.2 percent of medically treated patients. The HbA1c of less than six is a more aggressive target than the American Diabetes Association guidelines.

Participants entered the study taking an average of three medications each for diabetes. In all of the gastric bypass patients who achieved the target level, the normal blood sugar was attained without use of any diabetic medications. Seventy-two percent of sleeve patients who reached normal blood sugar also did so without the use of any diabetic medications. In surgically-treated patients who continued to require drugs, researchers observed a substantial reduction in the need for diabetic medications.

The patients who received bariatric surgery lost more weight during the 12-month study, averaging 64.7 pounds for patients who received gastric bypass, 55.2 pounds for patients who had stomach reduction surgery, and 11.9 pounds for patients treated with medications.

The study authors reported some complications of surgery, but most were not serious. However, four patients did require a second operation. The study authors caution that the favorable results were observed after a relatively short follow-up period (12 months) and that long-term studies are needed to determine the durability of the findings. The authors will continue to follow these patients for four years to attempt to answer these questions.

More information on the clinical trial can be found at clevelandclinic.org/
stampede.

This study was funded by Ethicon Endo-Surgery, Inc., a subsidiary of Johnson & Johnson, which is a company that designs and manufactures medical devices and surgical instruments.

Bariatric Surgery Dramatically Outperforms Standard Treatment for Type 2 Diabetes
Rome, ITALY and NEW YORK (ScienceDaily)—Researchers from the Catholic University/Policlinico Gemelli in Rome, Italy, and NewYork-Presbyterian/Weill Cornell Medical Center found that bariatric surgery dramatically outperforms standard medical treatment of severe type 2 diabetes (T2D). These findings were published in an advanced online edition of the New England Journal Medicine (NEJM).

The study’s authors report that most bariatric surgery patients were able to discontinue all diabetes medications and maintain disease remission for the two-year study period, while none of those randomly assigned to receive standard medical treatment did.

In this study, most surgery patients experienced improvements in blood sugar levels, decreased total cholesterol and triglycerides, and improved HDL-cholesterol concentrations. This suggests that bariatric surgery for the treatment of diabetes may reduce a patient’s cardiovascular risk.

“The unique ability of surgery to improve blood sugar levels and cholesterol levels as well as reduce weight makes it an ideal approach for obese patients with type 2 diabetes,” says lead author Dr. Geltrude Mingrone, chief of the Division of Obesity and Metabolic Diseases and professor of medicine at Catholic University in Rome.
This was a randomized, controlled trial of patients aged 30 to 60.

This study evaluated remission of diabetes in 60 severely obese patients (those with a body mass index [BMI] greater than 35) with advanced diabetes. Patients were randomly assigned to three groups: one group underwent Roux-en-Y gastric bypass (RYGB); a second group had bilopancreatic diversion (BPD); and the third group received conventional individualized medication and rigorously monitored dietary and lifestyle modification.

None of the patients in the medical-therapy group has gone into remission since the start of the trial. By contrast, diabetes remission occurred and has been maintained in 95 percent of those who underwent BPD and 75 percent of those receiving RYGB. Remission is defined as fasting glucose of less than 100mg and hemoglobin A1c (HbA1c) of less than 6.5 percent for at least one year.

The authors found that age, gender, preoperative BMI, duration of diabetes and weight-loss post surgery were not predictors of diabetes remission.

“These findings confirm that the effects of bariatric surgery on type 2 diabetes may be attributed to the mechanisms of surgery rather than the consequences of weight loss,” says Dr. Mingrone.

All patients in the current study were treated in Rome. Dr. Mingrone and her team of diabetes specialists were responsible for medical treatment of patients in the study. Dr. Rubino, who also holds an adjunct academic title at Catholic University in Rome, performed the laparoscopic RYGB surgeries and a team of surgeons from the Catholic University performed the BPD procedures.

To read the full press release visit http://www.sciencedaily.com/releases/2012/03/120326133514.htm
The research conducted for this study was funded by the Catholic University of Rome, Italy.

References
1. Schauer PR, Kashyap SR, Wolski K, et al. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Mar 26. [Epub ahead of print]
2. Mingrone G, Panunzi S, De Gaetano A, et al. Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med. 2012 Mar 26. [Epub ahead of print]

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