Weight Loss Surgery News Blog

Link: http://weight-loss-without-surgery.com/

GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, today announced initial, positive results from a clinical trial evaluating 12 months of treatment with the EndoBarrier™ Gastrointestinal Liner. The first group of patients from this trial have successfully completed 12 months, or 52 weeks, of treatment with the EndoBarrier Gastrointestinal Liner, an important milestone in the clinical development of this non-surgical therapeutic. The clinical trial was led by Eduardo G. Moura, M.D., Ph.D., director of endoscopy, digestive surgery department, Hospital das Clinicas, University of Sao Paulo, Brazil.

“Successful 12-month implantation with the EndoBarrier is a clinically important achievement and a promising indicator that this non-surgical medical device may offer our patients an innovative new solution to simultaneously combat both type 2 diabetes and obesity”

“Successful 12-month implantation with the EndoBarrier is a clinically important achievement and a promising indicator that this non-surgical medical device may offer our patients an innovative new solution to simultaneously combat both type 2 diabetes and obesity,” commented Keith Gersin, M.D., FACS, chief of bariatric surgery at Carolinas Medical Center and chief medical director of GI Dynamics. “The data we have seen previously in patients treated for up to six months is very compelling, and these data from 52 weeks of treatment further extend the potential impact and efficacy of this approach. I look forward to the full data set from this trial as the rest of the patients complete the 12-month mark.”

The 52-week trial was designed to evaluate the EndoBarrier Gastrointestinal Liner in 22 obese patients with type 2 diabetes. The primary endpoints in the trial include improvement in type 2 diabetes and excess weight loss. To date, the first six of the 22 subjects implanted with the EndoBarrier have successfully reached the 52-week endpoint.

The average baseline weight for the subjects was 270.5 lbs (± 22.2 1bs), average baseline HbA1c was 9.3% (± 0.8%) and subjects were taking oral anti-diabetes medications. Top-line results for the first six subjects show that on average patients achieved the following results:

HbA1c decrease of 2.5% (± 0.6%) with 5 of the 6 getting below 7.0%
25.9 % excess body weight loss (± 4.6%)
35.5 lbs weight loss (± 9 lbs)
“This is a landmark achievement for the EndoBarrier and GI Dynamics,” said Stuart A. Randle, chief executive officer of GI Dynamics. “I want to congratulate and thank our technical, clinical and scientific teams for their efforts which have led us to a successful 12-month device design and the meaningful results we have observed clinically to-date. We believe that EndoBarrier is well positioned to provide a transformative alternative to pharmaceutical and surgical methods for treating type 2 diabetes and obesity. This milestone further enhances the potential clinical value of the EndoBarrier offering.”

Addressing Unmet Need for Treating Type 2 Diabetes and Obesity

The EndoBarrier, a non-surgical therapy to treat type 2 diabetes and obesity, received European CE mark approval for the treatment of type 2 diabetes and obesity in December 2009. Clinical trials to date involving more than 280 patients have demonstrated the significant weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner.

Type 2 diabetes affects an estimated 21 million Americans and 200 million people worldwide. According to the World Health Organization, type 2 diabetes comprises 90% of people with diabetes around the world, and is largely the result of excess body weight. Type 2 diabetes can lead to significant health problems including cardiovascular disease, retinopathy, neuropathy and nephropathy.

GI Dynamics is defining a new class of metabolic treatment options that fit between pharmaceutical regimens and surgery, called non-surgical therapeutics. Non-surgical therapeutics are designed to eliminate or reduce the risks and side effects associated with pharmaceutical regimens as well as surgical options. This new class of treatment can be performed easily and quickly without any incisions, thus reducing patient anxiety and recuperative time. Unlike traditional pharmaceutical approaches, non-surgical therapeutics remove the burden of dose regimen compliance from the patient. Additionally, non-surgical therapeutics hold the potential to improve the patient’s overall health, by providing the control necessary to institute lifestyle and nutritional improvements to maintain therapeutic effect, while being easily removed once the desired effect has been attained and lifestyle changes implemented.

SOURCE GI Dynamics

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

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.

Link: http://www.robertorizzi.com

During the 1980s, cardiovascular mortality rates observed in Brazilian metropolitan areas were ranked among the highest in a comparison with certain selected countries.1 However, since then, these Brazilian rates have been decreasing with a peculiar pattern. During the 1990s, mortality rates from stroke followed a downwards trend, but mortality rates from coronary heart diseases (CHD) are now reaching a plateau without any evidence of a fall.

On the other hand, three national cross-sectional studies performed in 1973-74, 1988 and 1996 showed an alarming and impressive increase in the prevalence of obesity, especially among city-dwellers.2 Over this period, the prevalence of obesity (body mass index greater than or equal to 30 kg/m2) increased from 2.4% (1973-74) to 6.9% (1996) among men, and from 7.0% (1973-74) to 12.5% among women.

Recently, one observational study has detected that the decline in CHD mortality deaths in the USA has been slower among patients with diabetes than among those without it. Other data from a cohort of American nurses has shown that the increase in body mass index explained an 8% increase in the incidence of CHD events.

It is reasonable to speculate that the slowdown in the decline of CHD deaths in Brazil has been due to an increasing prevalence of both obesity and diabetes. Considering this fact, the epidemic of obesity must be halted, or else there will very probably be a new peak of coronary deaths in Brazil, in spite of the improvements regarding smoking restrictions and hypertension awareness and control that have been observed over the last few years.

Paulo Andrade Lotufo, MD, DrPh. Editor, São Paulo Medical Journal, Director, General Internal Unit, Hospital Universitário, Universidade de São Paulo, São Paulo, Brazil.

Link: http://www.robertorizzi.com

People who have obesity operations, such as gastric bypasses or banding, double their risk of suffering fractures, US research suggests. They found a fifth of patients suffered fractures - twice the rate typical for their age - with most breaks occurring in the bones of the hands and feet.

Previous studies have shown that bariatric surgery results in an increased bone turnover, the rate of bone breakdown and bone formation. Suspicion that this could cause an increased risk of fractures prompted researchers at the Mayo Clinic in Rochester, Minnesota to begin analyzing available medical records of the 292 patients who underwent bariatric surgery at their facility between 1985 and 2004. The majority, 90 percent, of the patients had gastric bypass surgery, while the other patients had either gastric band surgery or biliopancreatic diversion.

After reviewing 97 cases (86 women; average age of 44), the researchers found that within an average of seven years following surgery, there were 31 fractures reported in 21 patients. When compared to individuals of the same age and sex in the general population, those having bariatric surgery were 1.8 times more likely to have a first fracture at any site of the body. Fractures were reported in the upper arms, hip, and spine, but fractures at the hand and foot were the most elevated, with an increase of more than three times and almost four times, respectively, greater than average.

The findings have been presented at the Endocrine Society Annual Meeting.

Link: http://www.endocrinetoday.com

Ten studies spanning several obesity-related issues were issued in an effort to educate medical professionals about the current obesity research. This report was published in the Journal of Clinical Endocrinology & Metabolism.

These articles define the state-of-the-art obesity research at present:

1. findings showed the prevalence of obesity increased in Brazil, Canada, Mexico and the United States. The increase in the presence of obesity may create challenges for public health and medical systems in those countries.

2. evaluated the relationship between metabolic complications and childhood obesity. Many children and adolescents exhibited metabolic complications, putting them at risk for early morbidity

3. determined there is a need to conduct large, community intervention programs focusing on exercise and a healthy diet in developing countries to prevent death-related type 2 diabetes and cardiovascular disease.

4. high hereditability of adiposity remains unexplained, although advances have helped to explain underlying genetic mechanisms of obesity

5. study’s results showed that in obesity, inflamed fat-secreted proteins were associated with insulin signaling impairment

6.in a study of obesity-associated liver disease, a review of literature demonstrated the most prevalent liver disease in Western countries was of metabolic origin

7. researchers examined literature from PubMed and The Handbook of Obesity 2008 in another study. The data demonstrated surgery was the most robust method for losing weight

8. researchers examined the results of studies of operations including adjustable gastric banding, gastric bypass and biliopancreatic bypass with duodenal switch

9. also evaluated abandoned and current procedures, complications and patient selection. Bariatric surgery should be the therapy of choice until better approaches become available

10. a review of literature in which findings showed that understanding the central regulation of food intake may help with finding useful treatment options