Weight Loss Surgery News Blog

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A consensus statement on diabetes surgery is published online today in the Annals of Surgery. This appears the first statement towards a concenus of surgery for diabetes type 2.

At present, bariatric surgery is only available as a treatment for severe obesity, defined as having a body mass index (BMI) of 35 kg/m2 or more, according to National Institutes of Health (NIH) guidelines established in 1991. The DSS consensus statement acknowledges that the cutoff is arbitrary and not supported by scientific evidence, and recognizes the need to use more appropriate criteria for surgery in patients with diabetes.

The report illustrates the findings of the first international consensus conference -- Diabetes Surgery Summit (DSS) -- where an international group of more than 50 scientific and medical experts agreed on a set of evidence-based guidelines and definitions that are meant to guide the use and study of gastrointestinal surgery to treat type 2 diabetes. The document is considered to be the foundation of diabetes surgery as a medical discipline of its own.

In its position statement, the Diabetes Surgery Summit states: "Surgery should be considered for the treatment of type 2 diabetes" in patients with a BMI of 35 or more "who are inadequately controlled by lifestyle and medical therapy." The statement goes on to state that diabetes surgery may also be appropriate for treatment of people with type 2 diabetes and merely mild-to-moderate obesity (BMI 30-35). This goes beyond parameters established by the NIH for bariatric surgery in 1991, which reserved bariatric surgery for people with a BMI of 35 or more with an obesity-related condition, or a BMI of 40 or more with or without any obesity-related condition. These parameters are still adhered to by most insurance companies in determining coverage of the surgery.

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Link: http://www.robertorizzi.com/diabetic-surgery.htm

Obese patients with uncontrolled type 2 diabetes who were treated with an investigational endoscopic duodenal-jejunal bypass liner achieved near normalization of glycemic control in one week, as compared with a sham group. Implantation of the liner was also associated with reductions in fasting blood glucose levels and weight loss.

The EndoBarrier (GI Dynamics) is a non-surgical therapeutic device that is implanted in the gastrointestinal tract through an endoscopic outpatient procedure. It creates a barrier between food and the wall of the small intestine and thereby changes metabolic pathways by controlling how food moves through the digestive system.

In clinical studies conducted to date with the EndoBarrier, patients have experienced immediate resolution of type 2 diabetes while the EndoBarrier is implanted, and continued resolution of their diabetes after the device is removed, as well as the important benefit of weight loss.

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An ad in the November 15, 2009, edition of Parade magazine may be the opening salvo in a campaign to push adjustable gastric bands as a weight loss aid to help overweight type 2s dramatically improve their symptoms or even go into remission.

The ad for the LAP-BAND AP® System from Allergan, Inc., shows a pretty, overweight, young woman saying, "If I lost the weight, maybe I could improve, or even resolve, my type 2 diabetes." The ad text then discusses the product, which is a device that's placed around the upper part of the stomach and slowly inflated to create a sense of fullness that comes on faster and lasts longer than without the band.

By eating less, a patient fitted with the band can lose a large amount of weight without needing to resort to diets or sheer willpower. The benefit for type 2s is that dramatic weight loss often causes diabetic symptoms to lessen or even disappear

The band, which can be placed in an outpatient procedure, has an advantage over gastric bypass surgery in that it doesn't involve cutting and stapling. This means that the band can be removed relatively easily or adjusted post-procedure without intrusive surgery.

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The incisionless Weight Loss Surgery procedure, also known as POSE (Primary Obesity Surgery, Endolumenal) allows surgeons to decrease the size of the patient’s stomach without making an incision on the outside of their body.

Incisionless surgery offers several advantages over the traditional open and laparoscopic surgery including reduced risk of infection, less post-operative pain, and no visible scars. The procedure promises to reduce many of the serious complications often associated with bariatric surgery.

The incisionless procedure is performed using Incisionless Operating Platform (IOP) and a flexible endoscope. Physicians inserted the scope and the IOP through the patient's mouth. They then used the IOP tools to grasp the stomach tissue and deploy suture anchors to create multiple tissue folds in the stomach wall to reduce its size.

If the promise of the incisionless surgical procedure of reduced complications and faster recovery times holds true, incisionless surgery could significantly expand the number of patients who are able to undergo weight loss surgery.

Weight-loss surgery allowed a majority of obese type 2 diabetes patients to stop or reduce medical therapy, according to three studies reported here.

As many as 90% of patients had improved glucose control following bariatric surgery, investigators told attendees at the American Society of Metabolic and Bariatric Surgery.

Although many patients maintained the improvement for as long as five years, questions about the durability of the surgery's effects on diabetes remained unresolved.

"Beyond three years after Roux-en-Y gastric bypass there is a significant cohort of patients that experiences recurrence or worsening of their diabetes after an initial period of resolution or improvement," said Daniel Rosen, MD, of Columbia University in New York. "Poor weight loss and more weight regain were seen in the recurrence/worsening group."

"Before widespread acceptance and implementation of bariatric surgery as definitive treatment for diabetes, further study of this recurrence phenomenon is indicated."

Roux-en-Y gastric bypass led to early resolution of diabetes in 153 of 172 (89%) obese patients with type 2 diabetes, said Silas Chikunguwo, MD, of Virginia Commonwealth University in Richmond.

Patients who had complete resolution of diabetes had lost an average 70% of excess weight, and their mean body mass index (BMI) decreased from 50 to 31. The remaining 19 patients had persistent diabetes despite excess weight loss that averaged 58%, said Dr. Chikunguwo.

During follow-up of five to 16 years, 66 of the 153 patients (43.1%) had recurrence of diabetes, which was associated with weight regain.

Mean excess weight loss declined from 66% to 48.9% in patients who had recurrent disease.

"Long-term weight control appears important for durable resolution of type 2 diabetes," said Dr. Chikunguwo.

Data from New York University showed that 53% of patients with type 2 diabetes remained medication free five years after undergoing laparoscopic adjustable gastric banding.

In addition, the proportion of patients requiring oral hypoglycemic agents declined from 75% before the procedure to 39% at five years, said NYU's Samuel Sultan. Overall, 80% of the patients were medication free or on lower doses.

The analysis comprised 95 morbidly obese patients with type 2 diabetes who had weight-loss surgery from 2002 to 2004. Median and mean follow-up was five years.

Excess weight loss at five years averaged 48.3%. Mean BMI decreased from 46.3 at baseline to 35 (P<0.001), fasting glucose from 146 to 118.5 mg/dL (P=0.004), and hemoglobin A1c from 7.53% to 6.58% (P<0.001).

However, only 40% of patients met criteria for diabetes remission at five years: off all medication and either an HbA1c less than 6% or a blood glucose level less than 100 mg/dL.

Lack of diabetes remission at five years was associated with significantly lower excess weight loss (38.2% versus 57.3%, P=0.001).

Dr. Rosen presented data from a retrospective analysis of long-term results in 42 morbidly obese patients who had type 2 diabetes prior to gastric bypass surgery. The primary objective was to characterize patients who achieved long-term resolution of diabetes with those who improved but were not in remission.

Follow-up averaged five years, and all patients had been followed for at least three years.

He and his team defined resolution of diabetes as being off all diabetes medications plus either an HbA1c less than 6% or blood glucose less than 124 mg/dL. They defined improvement as a decrease in medication requirements.

Dr. Rosen said 27 patients met criteria for resolution after surgery and 15 were improved.

The high point for mean excess weight loss was 58.3%, and regained weight averaged 21%. Nine patients had weight-loss failure, defined as <50% excess weight loss.

Diabetes resolution was associated with slightly greater peak excess weight loss (61% versus 52%), fewer weight-loss failures, and lower baseline HbA1c and blood glucose levels.

Patients who had resolution of diabetes were significantly more likely to be on oral medications (P=0.0006), whereas significantly more patients who improved were on insulin preoperatively (P<0.0001).

During follow-up, 10 patients (24%) had either recurrence or worsening of diabetes.

Compared with patients who had no change in diabetes status at five years, recurrence and worsening were associated with:

Lower preoperative BMI (P=0.05)
Higher rate of weight loss failure (P=0.03)
Higher percentage of weight regained (P=0.002)
Higher postoperative blood glucose values (P=0.0002)
The reasons for diabetes recurrence are not entirely clear, said Dr. Rosen, but failure of the surgical procedure over time probably is not the cause. Upper gastrointestinal evaluations in five of seven patients with recurrence revealed no abnormalities.

More likely causes of diabetes recurrence are increased caloric intake (implied by weight gain), reduced insulin sensitivity, attenuation of the hormonal effects of the surgery, and progression of beta-cell dysfunction, he added.

Dr. Rosen disclosed relationships with Covidien, Storz, and Olympus. Fellow investigators Marc Bessler and Daniel Davis disclosed relationships with Covidien, Ethicon, and GI Dynamics and Allergan.
Dr. Chikunguwo and co-investigators reported no relationships.

Sultan reported no relationships. George Fielding disclosed relationships with Allergan and Analytica International. Marina Kurian disclosed relationships with Allergan. Christine Ren disclosed relationships with Allergan and Ethicon.

Primary source: American Society of Metabolic and Bariatric Medicine
Source reference:
Chikunguwo S, et al "Durable resolution of diabetes after roux-en-Y gastric bypass is associated with maintenance of weight loss" Surg Obes Relat Dis 2009; 5(3S): Abstract PL-101.

Additional source: American Society of Metabolic and Bariatric Medicine
Source reference:
Sultan S, et al "5-year outcomes of patients of type 2 diabetes who underwent laparoscopic adjustable gastric banding" Surg Obes Relat Dis 2009; 5(3S): Abstract PL-104.

Additional source: American Society of Metabolic and Bariatric Medicine
Source reference:
DiGiorgi M, et al "Recurrence of diabetes after gastric bypass in patients with mid to long-term follow up" Surg Obes Relat Dis 2009; 5(3S): Abstract PL-213.