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January 23, 2008

CHICAGO - A new study gives the strongest evidence yet that obesity surgery can cure diabetes.

Patients who had surgery to reduce the size of their stomachs were five times more likely to see their diabetes disappear over the next two years than were patients who had standard diabetes care, according to Australian researchers.

Most of the surgery patients were able to stop taking diabetes drugs and achieve normal blood tests.

"It's the best therapy for diabetes that we have today, and it's very low risk," said the study's lead author, Dr. John Dixon of Monash University Medical School in Melbourne, Australia.

The patients had stomach band surgery, a procedure more common in Australia than in the United States, where gastric bypass surgery, or stomach stapling, predominates.

Gastric bypass is even more effective against diabetes, achieving remission in a matter of days or a month, said Dr. David Cummings, who wrote an accompanying editorial in the journal but was not involved in the study.

"We have traditionally considered diabetes to be a chronic, progressive disease," said Cummings of the University of Washington in Seattle. "But these operations really do represent a realistic hope for curing most patients."

Diabetes experts who read the study said surgery should be considered for some obese patients, but more research is needed to see how long results last and which patients benefit most. Surgery risks should be weighed against diabetes drug side effects and the long-term risks of diabetes itself, they said.

Experts generally agree that weight-loss surgery would never be appropriate for diabetics who are not obese, and current federal guidelines restrict the surgery to obese people.

The diabetes benefits of weight-loss surgery were known, but the Australian study in Wednesday's Journal of the American Medical Association is the first of its kind to compare diabetes in patients randomly assigned to surgery or standard care. Scientists consider randomized studies to yield the highest-quality evidence.

The study involved 55 patients, so experts will be looking for results of larger experiments under way.

"Few studies really qualify as being a landmark study. This one is," said Dr. Philip Schauer, who was not involved in the Australian research but leads a Cleveland Clinic study that is recruiting 150 obese people with diabetes to compare two types of surgery and standard medical care.

"This opens an entirely new way of thinking about diabetes."

Obesity is a major risk factor for diabetes, and researchers are furiously pursuing reasons for the link as rates for both climb. What's known is that excess fat can cause the body's normal response to insulin to go haywire. Researchers are investigating insulin-regulating hormones released by fat and the role of fatty acids in the blood.

In the Australian study, all the patients were obese and had been diagnosed with type 2 diabetes during the past two years. Their average age was 47. Half the patients underwent a type of surgery called laparoscopic gastric banding, where an adjustable silicone cuff is installed around the upper stomach, limiting how much a person can eat.

Both groups lost weight over two years; the surgery patients lost 46 pounds on average, while the standard-care patients lost an average of 3 pounds.

Blood tests showed diabetes remission in 22 of the 29 surgery patients after two years. In the standard-care group, only four of the 26 patients achieved that goal. The patients who lost the most weight were the most likely to eliminate their diabetes.

Both patient groups learned about low-fat, high-fiber diets and were encouraged to exercise. Both groups could meet with a health professional every six weeks for two years.

The death rate for stomach band surgery, which can cost $17,000 to $20,000, is about 1 in 1,000. There were only minor complications in the study. Stomach stapling has a 2 percent death rate and costs $20,000 to $30,000.

In the United States, surgeons perform more than 100,000 obesity surgeries each year.

The American Diabetes Association is interested in the findings. The group revises its recommendations each fall, taking new research into account.

"There is a growing body of evidence that bariatric surgery is an effective tool for managing diabetes," said Dr. John Buse of the University of North Carolina School of Medicine in Chapel Hill, the association's president for medicine and science.

"It's just a question of how effective is it, for what spectrum of patients, over what period of time and at what cost? Not all those questions have been answered yet."

Medical devices used in the study were provided by the manufacturers, but the companies had no say over the study's design or its findings, Dixon said.

LAP-BAND® Adjustable Gastric Banding System is a minimally invasive surgery that involves applying a prosthesis (the LAP-BAND) around the stomach—creating a small gastric pouch—and a calibrated opening to the rest of the stomach.  

The advantages of LAP-BAND surgery include:

Reduced surgical trauma and pain

Less invasive for the abdominal wall (requires small incisions of 5 to10 millimeters) and for the stomach (no cutting or stapling of the organ is needed)

Shorter hospitalization than standard surgery

Respect of the anatomical and functional integrity of the stomach without by-passing portions of the stomach or intestines

Individualized to the patient's needs via inflation or deflation of the band

Fully reversible by simply removing the band.  

How It Works: 

By creating a smaller gastric pouch, the LAP-BAND System limits the amount of food that the stomach will hold at any time. The inflatable ring controls the flow of food from this smaller pouch to the rest of the digestive tract. The patient will feel comfortably full with a small amount of food. And because of the slow emptying, the patient will continue to feel full for several hours reducing the urge to eat between meals. 

According to medical literature, clinically severe obese people can never achieve long-term weight loss with dietary or behavioral modifications alone. A 100% failure rate is reported and a series of failures will again lead to enormous psychological problems. Known as the "yo-yo Syndrome," this situation creates additional physical burden on these already high-risk patients. Surgery is therefore indicated in these patients. 

Conventional obesity surgery is a high-risk procedure because of preoperative and postoperative morbidity. Preoperatively, access to the stomach is somewhat limited because of the enormous amount of fat surrounding the organ. Postoperatively, relative immobility of those patients facilitates blood clotting in deep veins of the legs and lung complications. 

The laparoscopic placement of an adjustable gastric band combines the advantages of this type of restrictive surgery that is less invasive than other obesity procedures because the abdomen is not actually opened. With this combination, operative risk is reduced as well as morbidity and patient discomfort. Total reversibility and adjustability of the band are clearly positive points. In October 1992, we were the first in the world to perform a laparoscopic gastric banding with the original, first generation Adjustable Silicone Gastric Band (ASGB), invented by Dr. Kuzmak. Technical modifications were made to the band in order to conform to the laparoscopic approach.       

     
LAP-BAND (Prosthesis)               Adjustable band applied around the upper part of the stomach
 

The selection criteria as defined by the American Society of Bariatric Surgery Consensus are listed in the table below.

Selection Criteria for Obesity Surgery:                  

BMI* (Body Mass Index) above 40 or between 30 to 40 in the presence of other associated diseases that may improve with weight loss (high blood pressure, diabetes, sleep apnea, and painful joint condition arthritis proven by x-ray)         

Age between 18 and 55 years         

Stable obesity for more than five years         

Failure of dietary or weight-loss drug therapy for more than one year         

Absence of glandular diseases such as hypothyroidism         

Comprehension of the procedure and compliance by the patient         

No dependency on alcohol or drugs         

Acceptable operative risk      

* BMI = weight in kg/height in meters squared.         


The Operation: 

The idea behind the operation is to create a small pouch in the upper part of the stomach with a controlled and adjustable stoma, without stapling, thus limiting food intake.  

A gastric band device is introduced through tiny (1cm) incisions in the abdomen and is placed around the upper part of the stomach. The resulting pouch (or the "new stomach") dramatically reduces the functional capacity of the stomach. The band has a balloon from the inside that is adjustable and can reduce stoma size, thus prolonging the period of fullness.  

The operation is performed under general anesthesia and can last between 30 minutes and 1 hour. The Band is fitted around the uppermost part of the stomach, forming a 15cc small pouch. It is designed so that it can be inflated or deflated at any time after the operation. This helps the patient continually lose weight until they reach their goals. The restriction takes place in the radiology suite and normally takes 15 minutes. This simple procedure is painless they inject saline into a port placed under the skin in the wall of the stomach. The tube that comes off of the band leads to the port. 

Advantages of gastric banding:

- No cutting of the stomach

- No stapling of the stomach

- Calibrated pouch and stoma size

- Can be adjusted to patient's needs after surgery with no operation

- Laparoscopic removal possible

- Fully reversible

- Short hospital stay (does not exceed 48 hours) 

     

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