Weight Loss Surgery News

Fitting A Lap-Band Could Be A One In Five Gamble At Best

2010-02-03T16:05:00.000-08:00

Some obesity surgeons are reporting dissatisfaction with the adjustable gastric lap-band. Gastric surgeons are finding a percentage of people do not get on with the laparoscopic gastric band.

One in five will have the band removed within five years, costing up to as much again as the original outlay in having the band fitted in the first place.

For those for which it works such as Sharon Osbourne, Ann Wilson (lead singer of the rock band Heart), Anne Diamond (British TV personality) it can be a great success. However in 2006 Sharon Osbourne announced on the Howard Stern Show that she gained 15 pounds in 2005 and was having the band removed. It should also be remembered, that Anne Diamond wrote and said a great deal on television and in the media about the problems she had, for some time after having her lap-band fitted.

Surgeons say that The problem seems to be with the fact that placing any kind of foreign body in the system particularly when it is applying constant pressure against the oesophagus is likely to lead to discomfort and irritation in the long term. This risk is exasperated by the additional burden of having to stick to a strict regime of band adjustments and dietary requirements that are demanding and regimented. Most people become tired and disenchanted with the regime and adjustments 6 years after having the band fitted. Many convert to a gastric bypass, with the conversion costing more than a gastric bypass in the first place.

The advice is if you choose to have an adjustable gastric lap-band, have the funds ready to have it removed or converted to a gastric bypass. Alternatively go for the bypass in the first place, with a better than 99.9% satisfaction rate, you are on a way better gamble.

Source: Direct Healthcare international Limited www.direct-healthcare.com

Parents Don't Realize their Kids are Obese

2010-02-03T15:53:00.000-08:00

50% the mothers who took part in a study thought that their obese four or five year-old was a normal weight, as did 39% of fathers, according to the February 2010 issue of Acta Paediatrica.

When it came to overweight children, 75% of mothers and 77% of fathers thought that their child was a normal weight. More than 800 parents of 439 children took part in the study, carried out by researchers from the University Medical Centre Groningen in The Netherlands. 5% of the children were overweight, 4% were obese and the rest were normal weight. "As well as asking them to provide information on their child's height and weight, they were also asked to provide information on their own vital statistics" says Professor Pieter Sauer from the Department of Paediatrics. "We used this to compare the parents' assessment of their children with their own weight to see if there was any correlation. Data on the child and both parents was provided in 397 cases."

The study showed that:

Mothers and fathers of overweight and obese children were significantly heavier than the parents of normal weight children.
Parents were more aware of their own weight. 83% of the overweight mothers and 78% of fathers realised that they were too heavy, as did 98% of obese mothers and 96% of obese fathers.
When asked to choose their child's body shape from seven different sketches, 97% of parents with normal weight children chose a lighter sketch than the data provided indicated.
The same was true of 95% of the parents of overweight children and 62% of the parents of obese children.
Parents of normal weight children tended to think their child was one size smaller than their true Body Mass Index (BMI) indicated and parents of obese children often chose sketches that were three slimmer.
Most of the parents did not worry about their child's weight, but the mothers of obese children were more likely to be concerned than the mothers of normal weight children (44% versus 7%).
Parents of overweight and obese children did not think their children were less active than others and 94% felt they could influence their child's food choices and eating habits.
Approximately four out of five parents said they would want to receive information or guidance if their child was overweight, regardless of how they viewed their child's current weight.

"It's estimated that 10% of children in The Netherlands are overweight, compared with 20% in the USA" says Professor Sauer. "However, public perception of what is a normal weight has shifted upwards because more people are overweight or obese. "Overweight children are very likely to become overweight teenagers and adults, so intervening when they are aged between three and five could prevent weight problems later in life. "It is vital that parents are aware of their children's weight if we are to prevent them becoming obese in later life. "The fact that the parents in our study perceived their children to be lighter than their BMI indicated is cause for concern. "Our findings point to the need for health education programmes that encourage parents to recognise what is a normal healthy weight for their children and work with health professionals to tackle any weight problems."

The paper can be accessed free at: www3.interscience.wiley.com/cgi-bin/fulltext/122680148/PDFSTART

How do parents of 4 to 5-year-old children perceive the weight of their children? Luttikhuis et al. Acta Paediatrica. 99, pp 263-267. (February 2010). DOI: 10.1111/j.1651-2227.2009.01576.x

Source: Annette WhibleyWiley-Blackwell

Childhood Obesity Increases Risk of Heart Disease

2010-02-03T15:51:00.000-08:00

Being obese from as early as 7 years of age, may raise a persons risk of heart disease and stroke, even in the absence of other cardiovascular risk factors such as high blood pressure, according to a new study accepted for publication in The Endocrine Society's Journal of Clinical Endocrinology & Metabolism (JCEM).

"This new study demonstrates that the unhealthy consequences of excess body fat start very early," said Nelly Mauras, MD, of Nemours Children's Clinic in Jacksonville, Florida and senior author of the study. "Our study shows that obesity alone is linked to certain abnormalities in the blood that can predispose individuals to developing cardiovascular disease early in adulthood. These findings suggest that we need more aggressive interventions for weight control in obese children, even those without co-morbidities of the metabolic syndrome."

The metabolic syndrome is a cluster of risk factors that raise the risk of developing heart disease, stroke and diabetes. It is being increasingly diagnosed in children as being overweight becomes a greater problem. Although debate exists as to its exact definition, to receive a diagnosis of metabolic syndrome, one must have at least three of the following characteristics: increased waist circumference (abdominal fat), low HDL ("good") cholesterol, high triglycerides (fats in the blood), high blood pressure and high blood glucose (blood sugar).

Researchers therefore screened more than 300 children aged 7 - 18 years and excluded those with features of the metabolic syndrome. The remaining 202 participants took part in the study: 115 obese children and 87 lean children as controls. Obese children had a BMI above the 95th percentile for their sex, age and height.

To be eligible to participate in the study, the children and adolescents had to have normal blood sugar levels, blood pressure and cholesterol and triglycerides. Lean controls also could not have a close relative with type II diabetes, high cholesterol, high blood pressure or obesity. (This group proved very difficult to find.)

All participants underwent blood testing for known markers for predicting the development of cardiovascular disease. These included elevated levels of C-reactive protein (CRP), a marker of inflammation, and abnormally high fibrinogen, a clotting factor, among others. Obese children had a 10 fold higher CRP and significantly higher fibrinogen concentrations, compared with age- and sex-matched lean children, the authors reported. These abnormalities occurred in obese children as young as age 7.

The results were striking, as the children were entirely healthy otherwise. Although it is not yet known whether early therapeutic interventions can reverse high CRP and fibrinogen, it would be prudent for health care providers to advise more aggressive interventions to limit calories and increase activity in "healthy" overweight children.

"Doctors often do not treat obesity in children now unless they have other features of the metabolic syndrome,". "This practice should be reconsidered. Further studies are needed to offer more insight into the effects of therapeutic interventions in these children.

The article, "Obesity Without Established Co-morbidities of the Metabolic Syndrome is Associated With a Pro-inflammatory and Pro-thrombotic State Even Before the Onset of Puberty in Children," will appear in the March 2010 issue of JCEM.
Source: Aaron LohrThe Endocrine Society

Mayor Of London Joins Forces With New York To Battle Childhood Obesity

2010-02-03T15:48:00.000-08:00

The Mayor of London Boris Johnson has welcomed the findings of a new report tackling obesity in kids in both London and New York. The report "A Tale of Two ObesCities' was compiled by the London Metropolitan University and City University of New York. It was launched today at a City Hall seminar discussing flab fighting initiatives used in both cities.

In both London and New York City, childhood obesity rates are higher than in the United Kingdom and the United States as a whole. The report found that London and New York experience common challenges - both cities have highly mobile populations, child poverty and overcrowding .Recommendations included promoting activities like walking and cycling and building active design principles into building codes, and housing plans.

Key findings include:

Nearly 23 per cent of London's four years olds are obese, rising to 36.3 per cent by the age of eleven.
In New York 40 per cent of kids of a similar age are obese.
In both cities obesity rates are higher in boys than in girls.
Poorest children have highest rates of obesity - both cities are characterised by high levels of income inequality.

The report will help develop some of the plans in the Mayor's forthcoming Health Inequalities Strategy and officials from the Mayor's Office have worked closely with partners in New York on effective health initiatives.

Mayor Boris Johnson said: "A superb 2012 legacy for London would be the obliteration of childhood obesity. We are championing effective plans across the capital to fight this and I hope that working with New York will result in leaner, fitter children and families in both our cities.
"I want to take on the fast food companies who mercilessly lure children into excessive calorie consumption. Instead of junk snacks let's encourage kids to grow their own food. Many youngsters are unaware of the magic of seeing a seed flourish into a nourishing item you can eat. If schools can help create mini-farms we could cultivate a nation of enthused Jamie Oliver's.
"I'm also investing millions in the sports and parks that every child in our city should have access to. Cycling, swimming, football and running round parks are great physical exercise and most importantly, immense fun. We must also help the poorest communities who are most vulnerable to bad diets of poor quality food. A key part of my health inequalities plan is to increase access to affordable healthy alternatives. "

Eileen O'Keefe Professor of Public Health, London Metropolitan University said: "'London and New York face common challenges with highly mobile populations, child poverty, and overcrowding. The report demonstrates that the two cities' approaches towards tackling these issues are different, and so they could benefit from collaboration and learning from each other's experiences."

Guest speakers at the health event included Rosie Boycott, Chair of London Food, who discussed the need for more sustainable food growth and local food growing projects. Pamela Chesters, the Mayoral adviser on Health and Youth Opportunities discussed ways food providers could offer a better range of appetising healthy menus.

Notes

In children, overweight is usually defined as having a body mass index (BMI), a measure of body fat based on height and weight, at or above the 85th percentile for age and gender and obesity as having a BMI at or above the 95th percentile.
To compile the report, London Metropolitan University and the City University of New York convened health officials, researchers, advocates, and city leaders from London and New York to analyze their epidemics of childhood obesity, compare responses, and recommend strategies for reversing these epidemics.
Recommendations made by the report fall under the five headings: land use and planning; food; parks and green space; transportation; schools, and research and training. For further information about the report contact Irene Constantinides, PR Officer, London Metropolitan University 020 7320 2346 I.Constantinides@londonmet.ac.uk
Headline conclusions include identification that London and New York:
- Experience common challenges (eg. both cities have highly mobile populations, child poverty and overcrowding) - Have developed some common solutions (eg. both have endorsed planning and other action on access to healthier choices as key means of tackling obesogenic environments - Both cities could benefit from further collaboration to learn from each other's experience
Recommendations include: - Build active design principles into building codes, housing strategies - Promote and support urban agriculture as a sustainable and health promoting use of green spaces; - Promote access to places where people can by physically active and promote walking and cycling; - Implement a universal free school meal program with nutritional standards- Promote research to help cities understand how the beat health inequalities
For more information on the Mayor's forthcoming Health Inequalities Strategy visit www.london.gov.uk

SourceMayor of London

NHS comments on lack of Access To Weight-Loss Surgery Claim

2010-02-03T15:46:00.000-08:00

David Stout, director of the NHS Confederation's PCT Network, comments on claims by the Royal College of Surgeons that patients are not being given appropriate access to weight-loss surgery on the NHS.

"All PCTs are working with local NHS services to deal with the increasing rates of obesity in England and have arrangements in place to treat those patients who will require surgery.
"The National Institute for Health and Clinical Excellence (NICE) provides PCTs with guidance on which patients should be considered for weight-loss surgery as part of a wider strategy to address obesity including encouraging natural weight loss through other means. Additionally, all PCTs have public health strategies in place which encourage a healthier diet and lifestyle.
"PCTs need to balance their priorities across a wide range of services, taking into account NICE guidance in the context local needs. But it is important that all commissioners are transparent in their decision-making."

Notes
The PCT Network represents the majority of primary care trusts in England. It was established in December 2006 to provide a distinct voice for PCTs.
SourceThe NHS Confederation

Five Questions You Should Ask Your Doctor About Losing Weight

2010-02-03T15:43:00.000-08:00

The American Society of Bariatric Physicians (ASBP) works with physicians so they're better prepared to deal with society's obesity epidemic. Even though people focus on weight loss more in January than any other month, successful weight loss is a year-round long-term initiative that goes far beyond just diet and exercise. The ASBP has highlighted five questions everyone who needs to lose weight should ask their physician.

1. Do I have other conditions that may be keeping me from losing weight?
It is important when you begin any weight loss program that you visit with a bariatric physician who can identify any weight-related conditions that can slow or stop successful weight loss. A bariatric physician will do a complete medical work-up to assess your overall health and metabolic state.

2. Do I have hypothyroidism?
Hypothyroidism is a condition in which the body lacks sufficient thyroid hormone. Since the main purpose of thyroid hormone is to "run the body's metabolism," it is understandable that people with this condition usually have a slow metabolism and thus, difficulty losing weight. A bariatric physician can identify a thyroid problem and provide a treatment plan that addresses hormonal and metabolic problems.

3. How are my Vitamin D levels?
Vitamin D levels are almost always low in patients who are overweight. Low Vitamin D levels can cause fatigue, muscle pain, bone pain and an overall feeling of lethargy, making it hard to lose weight.

4. Am I insulin resistant?
Insulin resistance turns off fullness signals to the brain. Typically, the heavier a person is, the more insulin resistant they may be, making them feel less full, causing them to continue to overeat. It is a complex condition that can be treated with the use of medications, exercise and dietary changes. Once it is treated, patients can feel more satiated, leading to more effective weight loss.

5. Am I ready for exercise?
This question may seem obvious, but exercise can be dangerous cardiovascularly in patients who are severely overweight. The heavier a person is, the more prone they are to injury. Often, it makes more sense medically for a patient to lose weight first and implement an exercise program when it is safe to do so, using exercise to maintain weight.
Source: The American Society of Bariatric Physicians

Obesity Increases Cancer Risk

2010-02-03T15:42:00.000-08:00

Obesity comes with plenty of health risks, but there's one that's perhaps not so well known: an increased risk of developing cancer, and especially certain types of cancer like liver cancer. Now, a group of researchers reporting in the January 22nd issue of the journal Cell, a Cell Press publication, have confirmed in mice that obesity does indeed act as a "bona fide tumor promoter." They also have good evidence to explain how that happens.

"Doctors always worry about our weight, but the focus is often on cardiovascular disease and type 2 diabetes, both of which can be managed pretty well with existing drugs," said Michael Karin of the University of California, San Diego. "However, we should also worry about elevated cancer risk. If we can reduce cancer deaths by as many as 90,000 per year, that's a lot of people - a lot of lives."

Karin's team shows that liver cancer is fostered by the chronic inflammatory state that goes with obesity, and two well known inflammatory factors in particular. The findings suggest that anti-inflammatory drugs that have already been taken by millions of people for diseases including rheumatoid arthritis and Crohn's disease may also reduce the risk of cancer in those at high risk due to obesity and perhaps other factors as well, Karin said.

The epidemiological studies reported earlier showed that obese people have about a 1.5-fold increase in their risk of cancer overall. That may not necessarily sound like a lot, Karin said, but it equates to about 90,000 extra cancer deaths per year in the United States alone. When it comes to liver cancer, the study showed obese people have a 4.5-fold greater risk.
Given the apparent connection between obesity and liver cancer in particular, Karin's team decided to investigate in mice prone to develop hepatocellular carcinoma (HCC). The mice are typically given HCC either by exposure to a chemical carcinogen, known as DEN, when they are two weeks old, or by exposure to that same carcinogen at three months of age followed by the tumor-promoting chemical phenobarbitol.

In the new study, the researchers gave two-week-old mice DEN and then divided them into two groups - one fed a normal, relatively low-fat food and the other fed on high-fat chow. "It was clear that the mice on the high fat diet developed more liver cancer," Karin said.
To further confirm the link, they gave DEN to two-week-old mice that were fed a normal diet but carried a gene that made them obesity-prone. Those mice, too, developed more liver cancers, evidence that it wasn't the high-fat diet that led to cancer, but rather something about the animals obese state.

But Karin said perhaps the biggest surprise came in studies of mice on a high-fat diet who were given DEN a little later in life, when they were three-months-old. Normally, mice on the standard diet given the chemical at that age really don't develop liver cancer unless DEN exposure is followed up with phenobarbitol, Karin explained. But the obese mice developed the disease without that extra push.

"We expected to see more cancer in our first experiments, but I was stunned to see here that only the mice who were obese developed the cancer," Karin said. "Obesity appears to be as strong as phenobarbitol; we can conclude, at least in mice, that obesity is a real tumor promoter."

His team was able to trace the source of obesity's tumor-promoting effect to a rise in two inflammatory factors known as IL-6 and TNF. Obese mice lacking either the TNF receptor or IL-6 don't show the same rise in liver cancer.

Those treatments also led the mice to accumulate less fat in their livers, he said. "They still get fat, but the distribution of the fat is different," he said. "The fat goes to other places, but not to the liver."

Karin suggests that clinical studies of people who are already taking anti-TNF drugs should be done, to find out if their livers are less fatty and cancer-free.
The researchers include Eek Joong Park, Jun Hee Lee, Guann-Yi Yu, Guobin He, Syed Raza Ali, Ryan G. Holzer, Christoph H.Osterreicher, Hiroyuki Takahashi, and Michael Karin, of University of California, San Diego, La Jolla, CA.

Source: Cathleen GenovaCell Press

NICE Responds To Weight-Reducing Surgery Concerns

2010-02-03T15:37:00.000-08:00

Commenting on claims by UK bariatric surgeons that some obese patients are not getting access to the NHS weight-loss surgery they need as recommended by NICE, a NICE spokesperson said: "We must be clear that obesity is a killer. It causes serious medical conditions that can result in death. The NHS is currently spending billions of pounds treating obesity and the conditions it causes. If, by recommending surgery for people who are morbidly obese [that is, with a BMI >40, or between 35 and 40 if they also have other serious health conditions], NICE can help to reduce the number of morbidly obese people, we can also make cost savings for the NHS in the long run.
"The NICE guideline on the prevention, identification, assessment and management of overweight and obesity in adults and children is very clear that this treatment is only for people who are severely overweight, who are already receiving treatment in a specialist clinic and who have tried other treatments to lose weight in the past. It is important to stress that surgery to aid weight loss is not something that people enter into lightly. It is a radical procedure, with potentially serious side effects. It also requires a huge lifestyle change on the part of the individual undergoing surgery as well as a commitment to the need for long-term follow-up.
"It is in the interests of people who are morbidly obese that Trusts work towards offering weight loss surgery according to the recommendations in the NICE guidelines as quickly as possible so that there is consistent and fair access to this treatment in England and Wales.
"We would strongly urge the NHS to use the criteria set by the NICE guideline so that they can be confident they are working to evidence based standards. We are working to support local NHS bodies to put our guideline into practice and our local implementation consultants are available to offer support and advice to PCTs and Trusts on implementation issues. We have also produced a commissioning guide to help health professionals in England to commission an effective bariatric surgical service for the treatment of people with severe obesity."
The NICE guideline and the commissioning guide are available from our website.
SourceNICE

Pregnancy Complications Of Maternal Obesity

2010-02-02T02:32:00.000-08:00

New research to be published in BJOG: An International Journal of Obstetrics and Gynaecology points to a strong association between maternal obesity and adverse pregnancy outcomes.
Previous research has shown that maternal obesity is associated with pregnancy complications such as hypertensive disorders, gestational diabetes and maternal death; and fetal/neonatal complications such as stillbirth, birth defects, macrosomia (big baby syndrome) and shoulder dystocia.
The data for this research was from the Hyperglycaemia and Adverse Pregnancy Outcomes study (HAPO) which examined the associations of mild hyperglycaemia with pregnancy outcomes. There was strict selection and researchers looked at the records of 23,316 pregnant women from 15 centres in nine countries. All participants had their BMI measured and underwent a standard oral glucose tolerance test (OGTT) between 24 and 32 weeks gestation. Samples of their random plasma glucose (RPG) were taken at 34 - 37 weeks. Ethnicity was recorded and lifestyle data were also collated (eg. smoking levels, alcohol consumption, history of diabetes and hypertension etc) using standardised forms. After delivery (within 72 hours), the size of the babies was assessed using standard measures.
Researchers found that increased maternal obesity was strongly related to adverse pregnancy outcomes. For the mother, it includes a higher chance of having pre-eclampsia and delivery by caesarean section. For the newborn, it resulted in having a higher birthweight, increased fat deposits and neonatal hyperinsulinemia (excess levels of insulin in the blood). In this study, preterm delivery was less frequent with higher BMI, a finding that, as researchers note, is consistent with other large studies.
Researchers conclude that because obesity is rising in most societies, the results have important practical and health economic implications. In order to reduce adverse fetal and maternal pregnancy outcomes, prevention and optimum treatment of maternal obesity is needed.
Boyd Metzger, Professor of Metabolism & Nutrition at the Northwestern University Feinberg School of Medicine in Chicago, who led the study, said "This paper demonstrates clearly for the first time that both maternal obesity and maternal hyperglycaemia have important and independent effects on pregnancy outcomes. Previously, there has been debate over whether the effects of obesity are caused primarily by associated elevation of blood glucose and conversely some have argued that the effects of mild hyperglycaemia primarily reflect maternal obesity.
"The HAPO study data presented in this paper and in previous publications show that both factors strongly affect fetal size and fatness of infants at birth. Furthermore, both are strongly associated with preeclampsia, one of the commonest and most serious pregnancy complications.
"On a worldwide scale, the increasing prevalence of obesity is likely to strain health care resources, with increased rates of caesarean section and hypertension. Effects on the next generation due to the association of increased fetal adiposity with future diabetes and obesity may well compound the future effects of the epidemic of obesity."
Professor Philip Steer, BJOG editor-in-chief said, "Across the developed world, we are experiencing an obesity epidemic. So much is being said about the world becoming fatter and unhealthier but if nothing constructive is being done now, then, this public health scare will become a harsh reality in the next generation.
"We have known about the pregnancy complications that result from a high BMI. This international study is further proof that something needs to be done urgently so that health outcomes for mother and baby are good."
Notes
BJOG: An International Journal of Obstetrics and Gynaecology website www.bjog.org is owned by the Royal College of Obstetricians and Gynaecologists (RCOG) but is editorially independent and published monthly by Wiley-Blackwell. The journal features original, peer-reviewed, high-quality medical research in all areas of obstetrics and gynaecology worldwide.

Reference
"HAPO Study Cooperative Research Group. Hyperglycaemia and Adverse Pregnancy Outcome (HAPO) Study: associations with maternal body mass index."BJOG 2010; DOI: 10.1111/j.1471-0528.2009.02486.x.
SourceRoyal College of Obstetricians and Gynaecologists

Chewing Gum Helps Weight Loss Surgery Recovery

2010-01-26T11:44:00.001-08:00

A new study has found that chewing gum after undergoing a stomach-related surgery significantly increases the recovery process.

The study suggests that chewing gum helps the recovery of bowel function, a problem that has troubled patients and physicians for decades, following gastrointestinal surgery.

Patients, who chew three to five pieces of gum a day after their operation, leave hospital two to three days earlier.

It is believed that the healing process following gastric surgery causes a sort of paralysis of the intestines (ileus) and it is only after four to five days that the patient can start eating again.

It seems that chewing gum stimulates the nerve pathways to the brain and to the stomach to speed up the return of bowel function, it tricks the body into thinking that you are eating.

Another benefit, according to patients, is that chewing gum keeps their mouths from feeling dry.

Flow restrictor for EndoBarrier™

2010-01-26T11:37:00.000-08:00

GI Dynamics announce that they have undertaken preliminary tests for the new flow restrictor to be added on the end of the EndoBarrier™.

Although it is still some time before the EndoBarrier™ Flow Restrictor receives approval the preliminary testing shows that the Flow Restrictor when used in conjunction with the EndoBarrier™ Gastrointestinal Liner “have an enhanced effect on weight loss”. GI Dynamics says it is conducting ongoing clinical studies investigating the synergistic effects of the combined devices and look forward to sharing these results at an upcoming medical meeting later this year.

Weight Loss Data for the EndoBarrier™ Technology Platform was Presented At The Society Of American Gastrointestinal and Endoscopic Surgeons Annual Meeting in 2009.

Previous studies have demonstrated the dramatic weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner. This latest data suggest that the combination of the EndoBarrier Gastrointestinal Liner with the EndoBarrier Flow Restrictor could enhance the effectiveness of the liner by nearly doubling the amount of weight-loss achieved by using the liner alone.

"These findings support what we have seen to date in other preclinical studies with both devices individually, confirming that combining the EndoBarrier Gastrointestinal Liner with the EndoBarrier Flow Restrictor have an enhanced effect on weight loss," said Dr. Gersin. "In clinical studies of the EndoBarrier alone, we have seen a substantial effect on weight loss and resolution of type II diabetes, and we anticipate we will see enhanced weight loss with the combination of these two devices in human clinical trials."

Pilot study results on EndoBarrier released

2010-01-26T08:51:00.000-08:00

GI Dynamics' EndoBarrier ™ Gastrointestinal Liner Demonstrates Significant HbA1c Reduction In Obese People Living With Type II Diabetes

GI Dynamics, a leader in non-surgical treatments for type II diabetes and obesity, today announced data which demonstrate that obese patients with uncontrolled type II diabetes using the EndoBarrier™ Gastrointestinal Liner achieved near normalization of glycemic control in just one week, as compared to a sham control group. In addition, patients treated with EndoBarrier achieved a mean reduction of 2.4% in HbA1c glucose levels versus 0.8% for the sham arm at 24 weeks. Patients treated with EndoBarrier also achieved reductions in other diabetic factors including fasting blood glucose and weight. The results of the pilot study were published today in the current advance online issue of Diabetes Technology & Therapeutics. "Studies show that every one percent decrease in HbA1c reduces health risks by 21 percent and as the rates of obesity and type II diabetes continue to reach epidemic proportions around the globe, patients are in urgent need of new therapeutic solutions that overcome the limitations associated with pharmaceutical regimens and invasive surgery," stated Christopher Sorli, M.D., F.A.C.E., Department of Endocrinology, Billings Clinic, Billings, Montana and lead study author. "The results seen in the pilot study published today are significant because they underscore the promise of EndoBarrier as a non-surgical therapy that may offer immediate and sustained glycemic control in patients most at risk for developing serious complications due to their diabetes." The trial was designed to evaluate the EndoBarrier Gastrointestinal Liner for the treatment of type II diabetes; the single-blind, long-term study was conducted in 18 patients with type II diabetes who were prospectively randomized to receive either the EndoBarrier Gastrointestinal Liner (n=12) or a sham endoscopy (n=6). The primary endpoint in the trial was the reduction of HbA1c (average blood glucose level over three months) in patients who had a baseline HbA1c of 9.1 percent and BMI (body mass index) of 38.9. Patients achieved the following results over a 24-week period, during which the device was implanted: - Patients treated with EndoBarrier achieved a mean reduction of 2.4% in HbA1c glucose levels versus 0.8% for the sham arm at 24 weeks; - Patients treated with EndoBarrier achieved a 55-point reduction in fasting blood glucose levels, another key indicator of diabetic status, versus a 42-point increase for the sham arm in one week; - Patients treated with EndoBarrier achieved a 20% decrease in the area under the glucose curve during a meal tolerance test at week one compared to a 17% increase in the sham arm. Keith Gersin, M.D., FACS, Chief of Bariatric Surgery at Carolinas Medical Center, stated, "In clinical studies conducted to date with the EndoBarrier, patients have experienced immediate resolution of type II 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. These results are similar to those seen with gastric bypass surgery; however the EndoBarrier is implanted endoscopically during an incision-less, outpatient procedure. " 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. "GI Dynamics is pioneering a platform of non-surgical therapeutics that affect key metabolic pathways resulting in gastric bypass-like resolution of type II diabetes and significant weight loss," said Stuart A. Randle, chief executive officer of GI Dynamics. "These data, published for the first time in Diabetes Technology and Therapeutics, further underscore the potential role that EndoBarrier may play in the lives of people battling type II diabetes and obesity, and the co-morbidities often associated with these challenging chronic diseases." About the EndoBarrier™ Gastrointestinal Liner The patented EndoBarrier Gastrointestinal Liner is an advanced investigational, non-surgical medical device based on the EndoBarrier Technology platform for treating type II diabetes and obesity. The EndoBarrier Gastrointestinal Liner is placed in the GI tract endoscopically (via the mouth) to create a barrier between food and the wall of the intestine. Physicians believe that preventing food from coming into contact with the intestinal wall may alter the activation of hormonal signals that originate in the intestine, thus mimicking the effects of a Roux-en-Y gastric bypass procedure without surgery. A growing body of preclinical and clinical evidence supports the potential for EndoBarrier Gastrointestinal Liner to dramatically change the treatment landscape for people living with type II diabetes, obese people at risk for type II diabetes, and people with severe weight problems. SourceGI Dynamics

European approval for EndoBarrier

2010-01-26T06:20:00.000-08:00

Here’s some great news for individuals suffering from type II diabetes and obesity. A recent announcement reveals that GI Dynamics has attained the European CE mark approval for the innovative EndoBarrier Gastrointestinal Liner system.

The system marks the entrance of a non-surgical therapy to treat type II diabetes and obesity. With the CE marking, the product has been certified to have met EU requirements for marketing in Europe. In addition to this, clinical trials that included over 270 patients claim to have exhibited the significant weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner.

Jan Willem Greve, M.D., Ph.D., Gastrointestinal and Bariatric Surgery, Atrium Medical Center Parkstad Heerlen, Netherlands, stated, “Based on the clinical results to date, we believe the EndoBarrier, as part of a multidisciplinary approach, has the potential to change the treatment paradigm for type II diabetes and weight problems. Due to its unique profile as a non-surgical and non-pharmaceutical treatment option, the EndoBarrier appears to provide the benefits of gastric bypass surgery without the complications and risks associated with surgery. Unlike traditional pharmaceutical approaches, this implantable device removes the burden of dose regimen compliance from the patient. We look forward to having access to the EndoBarrier as a new treatment option in our fight against these epidemics.”

Reportedly an estimated 21 million Americans and 200 million people worldwide are affected by type II diabetes. The World Health Organization indicates type II diabetes to comprise 90% of people with diabetes around the world, and largely the result of excess body weight. Significant health problems that could be a result of the disease include cardiovascular disease, retinopathy, neuropathy and nephropathy.

“This European approval for six months of EndoBarrier therapy to treat type II diabetes and obesity is another key milestone for GI Dynamics as we continue to prepare to launch the product in Europe,” mentioned Stuart A. Randle, chief executive officer of GI Dynamics. “The growing body of clinical data demonstrates the EndoBarrier is well positioned to offer a meaningful, non-surgical approach to controlling diabetic factors and facilitating weight loss in patients suffering from the twin epidemics of type II diabetes and obesity. With European marketing approval in hand, we look forward to initiating our commercialization plans in Europe in the first half of 2010.”

The EndoBarrier Gastrointestinal Liner is revealed to be an enhanced investigational and non-surgical medical device that finds its roots on the EndoBarrier technology platform for apparently treating type II diabetes and obesity. It is placed in the GI tract endoscopically through the mouth to produce a barrier between food and the wall of the intestine.

Physicians are of the opinion that preventing food from coming into contact with the intestinal wall could change the activation of hormonal signals that originate in the intestine. This could thus help in imitating the effects of a Roux-en-Y gastric bypass procedure without surgery.

Furthermore the potential of the system to completely transform the treatment landscape for people living with type II diabetes, obese people at risk for type II diabetes, and people with severe weight has been supported by progressing pre-clinical and clinical evidence.

You can expect this system to be available in the first half of 2010 in Europe.

The EndoBarrier a new gizmo for weight reduction..

2010-01-26T04:26:00.000-08:00

GI Dynamics has announced that is has on trial a new gizmo for weight reduction.

The EndoBarrier Gastrointestinal Liner system.

This beauty of this innovative system is that it is fitted endoscopically through the mouth, without the need for invasive surgery, much like the way a gastric balloon is fitted.

The system is currently being tried on a number of individuals at centres in Europe. It is initially envisaged that the EndoBarrier system will be used to reduce the weight of those seeking gastric bypass surgery, who are presently too heavy to safely undergo surgery.

Many people will herald the arrival of a new non invasive surgery method for weight loss.

Like the gastric balloon this is presently seen as a short term solution to weight loss, however it seems to be pointing the way to a possible quick and non surgical alternative to the gastric bypass.

Caution:
However surgeons are advocating caution. The extreme stress of a high BMI, on organs of the body, particularly the heart, creates huge risk factors for gastric surgery candidates.

Today the gastric bypass is the most successful means of sustained weight reduction in the long term. Once a surgery candidate’s BMI rises above 60 the risk factors multiply disproportionately, thus one sees a risk level that increases at an alarming rate. If the severely obese candidate reduces weight with something such as the EndoBarrier system, or gastric balloon, they may well reduce their BMI to below 60 however the risk factors of the higher BMI the candidate had will still be relevant. The surgery risk will not have declined significantly.

Another benefit is that like the gastric bypass the EndoBarrier system seems to also cure type II diabetes.

Anti-Obesity Drug Banned In Europe

2010-01-26T03:12:00.000-08:00

The European Medicines Agency (EMEA) has recommended that the appetite suppressant sibutramine, also known as Reductil, should no longer be prescribed by doctors and that pharmacists should no longer dispense the drug.

Review:

People taking sibutramine should see their doctor to discuss an alternative, although it is safe to stop taking the drug in the meantime if they wish.

The regulator has been conducting a review of safety and has concluded the increased risks of heart attacks and strokes do not outweigh the benefits.

A trial of 10,000 patients followed for six years comparing sibutramine to a placebo has not yet been reported but the regulator warned that heart attacks and strokes were more common in those taking the drug. People taking the drug only achieved modest weight loss when compared to those on a placebo, the report from the European Medicines Agency said.

Recommendations:

Diabetes UK Care Advisor Caroline Butler said: "Following recommendations from the EMEA, we would advise people with diabetes who are overweight and taking sibutramine to see their GP or healthcare professional to discuss an alternative weight loss drug.

"If people are concerned, they can stop taking sibutramine immediately."

Sibutramine was licensed for people classified as obese and should be taken for up to one year. More than 300,000 prescriptions for sibutramine were dispensed in England last year. Source:
Diabetes UK