EndoBarrier approved in Europe

On December 27, 2009, in Uncategorized, by Andrea

Wow!  Exciting news — this is a non-surgical method to help treat Type 2 Diabetes and obesity.  Basically a sleeve that is inserted via endoscope and helps malabsorb nutrients in the first portion of the small intestine without incisions or actual slicing and dicing of the guts.

The only question I have is this:  The website touts that when “the desired effect has been achieved, the device can be easily removed” — and even a patient testimonial states that “When it was time for it to come out, I wanted it to stay.”  So how long does / can the device stay in, and after it is removed, won’t the weight come back?

And how about another question?  Could this be used as a revision surgery for current WLS’es?

From GI Dynamics:

EndoBarrier

The EndoBarrierTM Gastrointestinal Liner may be the ideal treatment for patients with both type 2 diabetes and obesity. It works by creating a physical barrier between food that has been ingested and the intestinal wall. The EndoBarrier Gastrointestinal Liner is placed endoscopically (via the mouth) in a simple, brief procedure and is easily removed.

Hundreds of patients have been treated with the EndoBarrier System in clinical trials in South America, Europe, and the US.

From Medical News Today:

New Type 2 Diabetes And Obesity Treatment Approved – EndoBarrier Receives European CE Mark

Article Date: 26 Dec 2009 – 0:00 PST

GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, today announced that it has received European CE mark approval for the EndoBarrier™, a non-surgical therapy to treat type 2 diabetes and obesity. The CE marking (an acronym for the French “Conformite Europeenne”) certifies that a product has met EU requirements for marketing in Europe. Clinical trials involving more than 270 patients have demonstrated the significant weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner.

“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 2 diabetes and weight problems,” stated Jan Willem Greve, M.D., Ph.D., Gastrointestinal and Bariatric Surgery, Atrium Medical Center Parkstad Heerlen, Netherlands. “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.”

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.

“This European approval for six months of EndoBarrier therapy to treat type 2 diabetes and obesity is another key milestone for GI Dynamics as we continue to prepare to launch the product in Europe,” said 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 2 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.”

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.

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 2 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 pre-clinical and clinical evidence supports the potential for EndoBarrier Gastrointestinal Liner to change the treatment landscape for people living with type 2 diabetes, obese people at risk for type 2 diabetes, and people with severe weight problems.

Source
GI Dynamics

In case there was any doubt..

On December 27, 2009, in Uncategorized, by Andrea

I really am one of you.

Some people in the WLS community seem to be perfect in everything they do it seems.  They eat the perfect meals, take the perfect vitamins, have the perfect labs, go to the perfect surgeons, have the perfect surgery.  They are the golden children of WLS and they don’t mind telling everyone about it.  In excrutiating detail.  In annoying excrutiating detail.  And people seem to LOVE how these are inspirations to them — how perfect they can be, too.

I’m not perfect.  I’m just me.  In fact, I’m pretty broken most days.  And if I get my water down, my protein in the form of food (and not shakes since my pouch is picky right now), and my laundry done while not killing my two kids or my husband in the process — well, it’s a banner day in Andrea’s household.  I AM good about getting my vitamins in for some reason ;-)

I suffer from chronic pain.  This is something I live with, and try not to complain about too much.  I occasionally slip and whine a bit, but it’s the truth.  I wake up around 4:30 this morning in pain and take one of my pills.  Rather than go back to bed, like I should have, or even drink an RTD shake in the fridge which would still have been a better idea, I spy the box of Krispy Kremes that the husband brought into the house on Christmas Eve.

Now, I can leave most things alone when in the house.  Some, I cannot.  Most cookies (especially Oreos).  Skittles.  Swedish Fish.  Candy Corn.  Muffins.  Doughnuts.  GOOD peanut butter (mm.. honey roasted from Earth Fare..).  These are not safe from me at all.  And generally they don’t come into the house for this reason.  Proof?  Mom made some for Christmas and I didn’t even let her bring them in — I made her give them away.

So it’s 4:30am and I’m eating a doughnut.  I should also state that I’ve cleared the box pretty much by myself at various times since the box came through the door.  Not all at once — but one here and one there.

It’s the internet — I could pretend that I’m perfect, that I don’t have this compulsion to eat icing goodness of things (cause, let’s face it, it’s the icing that kills my self-control).  But that’s not me.

And this isn’t a confession.  It’s just a reassurance that while you read my information about vitamins and protein and news about stomach stapling and banding and such — that it’s a REAL person on this end of the computer and not some robot that does everything right 100% of the time.  Cause I’m not.  I’m one of you, and I’m not afraid to admit it.

Celebrate ENS Wild Cherry

On December 26, 2009, in Minerals, Reviews, Vitamins, by Andrea

To help start the new year off right, I’m trying to clear the backlog of reviews that I have promised myself I will do.  I’m starting with some of the Celebrate samples that I got in the mail last week when I mentioned to Celebrate on Twitter that I’ve not tried their new ENS line of product.

ENS Wild Cherry

Created for surgical weight loss patients, our Celebrate ENS (Essential Nutrient System) provides a full compliment of vitamins and minerals, plus 500 mg of calcium in each stick pack. Our integrated formula provides maximum solubility and ensures that the vitamins and minerals are readily bioavailable. This product is the best option for patients immediately following surgery.

* The vitamin and mineral content of each pack is equal to taking one chewable multivitamin plus 500 mg of calcium.
* The calcium that we have chosen is calcium lactate-gluconate, which is a highly absorbable form of calcium with excellent solubility properties.
* Due to the nature of the formulation, this product is appropriate for any surgical weight loss procedure. As with any of our other delivery systems, you may need additional supplementation based on surgery type.
* It is recommended to be blended with 8-16 oz of water, shaken, and consumed but can be mixed with as much or as little water as you want.
* Each pack also contains 4 g of soluble fiber, added electrolytes and a 500 mg antioxidant blend made with natural berries including acai berry, raspberry, blueberry, goji berry, strawberry and cranberry.
* Like our other products, taste is important and this has a delicious cherry flavor with just the right mix of sweet and tart.

Who would benefit from this product?
1. Early post-operative patients – Since this may be diluted to taste, there are virtually no issues with taste aversion. If you prefer a stronger flavor, use less water or if you prefer a lighter flavor, use more water.
2. Athletes – If you are a surgery patient turned athlete, this can help to flavor that boring water that you need to drink. Water is critical and taking your vitamins and calcium while hydrating makes it easier.
3. Anyone looking for a convenient alternative to pills or chewables.

So the instructions said to mix this with 8-16 oz of water, or dilute to lessen the taste.  I decided to try 12oz without having any clue how much or how little I’d like this.

ENS Wild Cherry -- Mixed

First impression — 12oz is a bit watery.  When I do the Grape review, I’ll be using 8oz of water instead.

The sniff test makes it smell a bit like minerally kool-aid.  It’s similar to the smell of opening a Flintstones bottle and taking a deep whiff.  That minerally smell that tells you that this is not just something good to drink, but an actual vitamin-thing.

Taste-wise — yeah, it’s definately a bit watery, but it’s not horrible.  It’s that mineral taste that gets to me, though, and would almost make me want me to thin it out a bit more to help get that taste thinned out a bit more.  This taste is what got me off chewables in the first place — vitamins are important, but hiding the taste of the important stuff is really really hard to do and I don’t think I could handle this drink on a regular basis.

If you can get past the mineraly taste, the stats are pretty good:

ENS Supplement Facts

500mgs of bioavailable calcium at the same time as a multivitamin — it helps those of us struggling to get all of our doses in..  to get 1500mgs of calcium and 2 multivites, you’d just need two of these tubes and one additional calcium dose, which is very do-able in most peoples’ schedules.

So my suggestion is to get a sample pack from Celebrate and try it out.  If it works for you, then consider it as a source for your multivite and calcium..

Runs $119.95 for a 90 day supply (180 doses total) at Celebrate.com

CLICK IN the New Year!

On December 26, 2009, in Uncategorized, by Andrea

Yes!  A CONTEST!  We all know how much Andrea likes to give things away!  And things that people give to Andrea to give away?!  EVEN BETTER!  (Note to companies who read this?  Andrea LOVES to give away swag.  Send me swag, I promote your stuff.)

Click In the New Year!

So how about a CLICK PACK?

Between 12/26 and 12/31, reply to this post with a resolution for the new year.  If you need help creating a resolution, try reading this post about SMART Resolutions for pointers.  Your resolution doesn’t have to be related to weight loss — pick something that is important to your life, but pick something.

On New Year’s Day, I’ll pull a radom number generator and pick a post number.  That person will get a Click Pack by mail.

Now, to put a comment on the post, you’ll have to create a WordPress account.  It’s one of those things that is part of the deal.  I don’t get access to the accounts, it’s their way of keeping the spam down on the blogs and I kinda like not having to delete sex spam from vitamin postings so I keep that part of the deal.  If you don’t want to create an account, maybe you can play on the FaceBook contest next time but this is part of the deal this time.

So get crackin!  I’ll pull the winner at midnight on New Year’s Day to CLICK IN THE NEW YEAR!

SMART Resolutions

On December 25, 2009, in Uncategorized, by Andrea

It's that time again...

Yes.  It’s that time again.

No.  Not the time where you swear you’ll never drink again.  That’s next week.

Now is when we start to think about resolutions.  We’ve eaten at holiday parties (if you’re lucky enough to still be working, AND to still be working for a company that still HAS holiday parties… not saying that we are or aren’t but we’ll just say that I didn’t have to buy a fancy outfit this year…) and the neighbors that you never speak to have brought over the obligatory cookie plate that you’ve nibbled on despite wondering about possible poisoning (hey, I’m a carb whore too — don’t tell me you wouldn’t either..  well, until after the spouse didn’t keel over first, of course).

So resolutions.  They’re good to have — even though most of them fly out of the window by March 1st.  I mean, we all have the best of intentions and do SOOOO well for the first month.  The second month we begin to wane.. but by the third month?  Whatever.  Game over, the end.  Kudos if you actually make it beyond the fourth month.. I can’t say I know a single person who’s made it to June, much less to the end of the year.  I mean, EVER.

And let’s face it — we all have the same resolutions!  Lose weight!  Save money!  Work less!  Laugh more!  Spend more time with the family!  It’s amazing.

When it comes to making resolutions, we should keep a few things in mind — and I’m gonna focus my examples on, duh! what else? weight loss, but these guidelines really can be used for anything.  Oh, sorry for the rambling.  I’m coming down from a carb coma (which is why I’m writing about resolutions NOW).  There are a few things to keep in mind when making resolutions.  We want to make our goals SMART.

Now, those of you in the corporate world are now groaning.  Go ahead, skip ahead to the end of the post to the fun part.  Those of you who are scratching your head and saying “why would people be groaning?” then stick around.

SMART is a mnemonic for SPECIFIC, MEASURABLE, ATTAINABLE, RELEVANT, and TIME-BOUND.

  • Specific:  Well, duh.  “I want to lose weight,” right?  Um, no.  SPECIFIC.  “I want to lose 48lbs.”  A very specific number.
  • Measurable:  This is easy — weight can be measured by a scale.  Use the same one, at the same time and write it down.  Don’t want to lose weight?  Lose inches, lose body fat %, save money — but have a goal that can be MEASURED.  Don’t have a goal that is unmeasurable — “I want to feel better” is a nice goal, yes — but how do you measure that?
  • Attainable:  It’s great to reach for something that you have to work for.  It sucks to put the bar so high that you can never get there and then get discouraged.  I’m 5 years post op.  It would be impossible for me to lose 20lbs in a month.  Fresh out of surgery?  Different story.  But setting such a goal would only kill my morale when I never ever EVER reach it.  What’s the point?
  • Relevant:  Make the goal fit your life.  For me, I could use some weight loss.  I’d like to lose about 20lbs to really be happy with myself.  This is my relevance.  This is not relevant to my skinny-ass husband who could eat ice cream for months and still be smaller than I am.  (BTW, I sorta hate him for that — only as much as one can hate their spouse when they love them to pieces sorta way.  You know what I mean.)
  • Time-bound.  Put a clock on your goal.  Sure, I want to lose 20lbs, but WHEN do I want to have it done by?  And even better, have check in points to monitor your progress.

So here’s the challenge.  I give this to you tonight to start thinking because starting tomorrow (12/26) through New Year’s Eve, I will be collecting your resolutions.  They can be a resolution for anything — saving money, losing weight, ANYTHING –

And what does this do for you?  Well, a few things.

  1. A public declaration of your resolution helps to make it more real.  At least, it does for me.  It gives me an audience to help kick my ass back onto track if I fall off of it.
  2. An entry into a contest!  Yes, Andrea likes contests, what can I say.  Your resolution gives you an entry for a Click Pack to help Click In the New Year!  The rules will be announced tomorrow.

Click In the New Year!

So start thinking on those resolutions…

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