Health for life

A cure for diabetes?

Mrs. Jones (name changed) was obese. Her weight remained persistently high despite education and entreaties about diet and exercise. She hated taking all those medications. She dreaded bathing suits.

And then.... she had bariatric surgery. She shed pounds faster than Supreme Court justices spanking a health insurance mandate. Instead of having a corpulent and unhealthy patient, the Disease Management Care Blog had a svelte and healthy patient.

Based on witnessing first hand patient transformations like this, the DMCB knows that bariatric surgery for obesity works.

Despite clinical anecdotes, however, obesity surgery skeptics have pointed out that the evidence has been marred by the lack of any prospective randomized clinical trials. Looking backwards at outcomes data cant rule out the possibility that something else was going on to account for the surgerys apparent success. Most of all, this includes self-selection bias where patients, who are destined to independently do well, select surgery. By leaving assignment to chance, docs and patients are out of the decision-making. This randomization helps researchers be more confident that the surgery, and nothing else, accounts for any observed outcomes.

Enter the New England Journal of Medicine, which published the results from two landmark prospective and randomized trials that compared obesity surgery to conservative medical management:

1. Geltrude Mingrone and colleagues screened 72 and then randomly assigned 60 diabetic persons with a BMI of 35 to either a) conventional medical therapy (targeting an A1c of 7% using a multidisciplinary team with visits every 3 months for a year and then one additional visit at two years) or b) gastric bypass or c) biliopancreatic diversion.  The study occurred at Romes Catholic University. Follow-up lasted two years. At the end of the study, 56 patients data were available for analysis. 15 of the 20 patients who had gastric bypass, 19 of the 20 patients who had the diversion and zero of the medically treated patients were off diabetes medications and had normal blood glucoses. As expected, surgery resulted in a whopping decrease in the BMI down to approximately 29.  In contrast the mean BMI was 43 in the medically treated group. Two patients had the surgical complications of hernia and obstruction

2. Philip Schauer and colleagues screened 218 patients and randomly assigned 150 diabetic obese persons with BMIs ranging from 27 to 43 to either a) medical therapy (life style counseling, weight management home glucose monitoring and medications with diabetes specialist clinic visits every three months that targeted an A1c of 6%) or b) "Roux en Y" bypass or c) sleeve gastrectomy. The study occurred at Cleveland Clinic. Follow-up lasted one year and 140 patients data were available for analysis. 5 of 41 patients in the medical therapy group vs. 21 in the 50 assigned to gastric bypass and 18 of 49 who had the sleeve achieved the A1c of 6%. Whats more, most of the surgery patients who achieved the targeted A1c were off all diabetes medications.  As expected, the surgery groups decreased their BMI down to the 26-27 range, while the medically treated patients BMI remained essentially unchanged.  In contrast to Rome, there was a wider range of complications that included 4 reoperations and 1 patient that developed a gastrointestinal leak with peritonitis.

Based on these data plus less pristine studies, its clinical experience and common sense, the DMCB is convinced that bariatric surgery works. These two studies are an important step forward in building the case for the use of this approach in persons with obesity and diabetes.

That being said, there is still room for some skepticism. That lingering doubt could be enough for a commercial insurer to limit coverage. It may be enough to prompt a PCP to recommend that an obese patient with diabetes should still hold off on surgery a bit longer. It may be enough for patients and families to wait another year until there are more confirmatory studies.

Heres why:

1. The studies were not "blinded." The purpose of "blinding" is to keep patients and doctors from being swayed by a "placebo effect." While thats intuitively silly, there is a possibility that having abdominal surgery made those patients believe they were going to lose weight and be cured of diabetes. After all, sham surgery has been known to help angina chest pains.

2. The studies are not necessarily "generalizable." Both studies were conducted by teams of surgeons from single institutions. While we can take Rome and Clevelands word for it, we dont know if obesity surgery done at Bumkinvilles Our Mother of Holy Deficit Hospital will have the same success and low rates of complications.

3. Speaking of complications, both studies were not adequately "powered" to fully assess mishap rates. While there were small single digit differences in the rates of complications, the small numbers may not tell the whole story. Having more patients enrolled in these studies would have increased the ability to meaningfully quantify all the possible bad outcomes.  That was one of the lessons of the Vioxx catastrophe.

4. Last but not least, the success of the surgery may have been inflated by the relatively poor performance of the non-surgical comparison groups. We know very little about the "intensity" of the medical treatment, other than they had the benefit of accessing a multidisciplinary clinic every three months. Population health management experts know that lifestyle change requires an intense program that includes engagement in a personalized and multidimensional care plan that includes far more frequent in-person and telephonic coaching. We dont know if the medical therapy group achieved this level of excellence.

Despite these limitations, however, the DMCB is more convinced that, for patients in whom nothing else works, bariatric surgery can reverse diabetes.

The headline declares: "Curing diabetes via surgery, without weight loss". Its a bold statement. Its enough to make one stop, and read. I admit I did just that.

Every week, it seems, we are bombarded with a new article declaring the magical, curative qualities of gastric bypass surgery. These articles make it seem like gastric bypass is the simplest, most sensible way of managing diabetes -- and gosh darn it -- everyone ought to pursue it so we can put a stop to this overwhelming epidemic thats going to just take over America, and murder us all. (Please note I am being sarcastic here.)

I admit I dont have all the answers -- if I did, Id have long ago found a cure for all of us, and retired to my white castle atop a hill, facing the ocean. But what I can tell you is that I have a lot of questions and skepticism. And so should you.

Whenever there are articles like this, I look for red flags:

• Is the article edited properly? It might seem like a simple thing, but honestly, if someone in a professional, journalistic setting, doesnt care enough to edit their articles for grammar, spelling, content, and accuracy, they certainly might not care about outright lying to you to get some readership.
• Is the article unusually chipper or eager to present this as an all around solution to a problem? Does it present ALL sides of the debate? Does it present ALL alternatives?
• Does the article portray accurate medical conclusions, information, and accurate explanations, or does it confuse the public about its target audience? 
• Does the article present accurate, statistical data, as has been reported by other research outlets, and scientific journals? 
• Is the study funded by third parties with deep pockets, and deep interests in the outcome of said study?

Taking all these questions into account, lets look at this weeks gastric bypass article (which I have linked to above.)

Red Flag #1

The article starts off by telling us about Cristina Iaboni (a woman who was selected as a test subject for gastric bypass in leaner patients), and offers this description of her situation:

"Cristina Iaboni had the dubious distinction of being not quite obese enough. For all the pounds on her 55" frame, she did not meet the criteria for bariatric surgery to help control her type-2 diabetes.  

Yet six years of medications and attempts at healthy living had failed to rein in her blood glucose, leaving Iaboni terrified that she was on course to have her kidneys fail "and my feet cut off" -- common consequences of uncontrolled diabetes." 

Right off the bat, Im kind of concerned about the quality of medical care Mrs. Iaboni may have received. Did her medical team question everything that needed to be questioned? Was she on insulin? When I read "6 years of medications," it literally screams at me that they kept her on every oral medication combination out there, and did NOT put her on insulin, like they should have. What kind of healthy living changes did she attempt to make? Was she she still consuming a high carbohydrate diet, and just substituted her carbs for wheat, and whole grains? Did she even know how to carb count? Did her doctor ever test her for antibodies, and is she a LADA, instead? While the article declares shes cured, I have the strong feeling this woman might rebound down the road.

Red Flag #2


Follow this logic statement with me: "If smoking triggers lung cancer, than smoking cessation should cure cancer."

Oh, it doesnt work that way, you say? Once you have it, youre stuck with it? Oh. Then why do some media and some researchers assume that if obesity triggers diabetes (in those who are genetically predisposed, mind you), that losing weight should cure the diabetes?

The simple answer is "I dont know." The complex answer is "Because they probably have something to sell you."

Certainly, one can assume smoking cessation helps better manage cancer -- I am sure. One will be healthier, and respond better to treatments, and will have a stronger immune system... But one cannot say one is suddenly cured of the cancer. (Even when one is in remission.) Diabetes and weight loss are much the same: weight loss merely makes one healthier, and be able to respond better to treatments (ie, be more insulin sensitive, use less insulin and medications, sometimes none, etc.) These are only ways of tightly controlling diabetes, though, and slowing down its progression. The absence of medicine is NOT an absence of illness. In this case, it is the strict diabetic patients regimen that is the patients medicine. The pancreas has damage, and this damage is irreversible, thus far. It is not, suddenly, magically healed.

Interestingly, this article seems ready to admit (though hesitantly so) that gastric bypass -- since people seemed to be magically better just days after surgery -- proves that a diabetic cure is NOT about weight control, or weight loss. However, here is where the red flag comes in: they are NOT willing to admit that the extreme dietary restrictions a patient must submit to (caloric and, consequently, carbohydrate level restrictions), post op, will play a role and immediately make less glucose available to the patient, and theore, less high blood glucose issues. Now, normally, a patient who chose to control diabetes with diet and exercise would take a bit longer to achieve euglycemia (or normal blood glucose levels) when consuming a diet lower in carbohydrates and eating normal amounts of food -- but they dont get a head start. A pre-op gastric bypass patient has to be on a type of fast with limited food and liquid intake, so theyre already starting out with less available glucose in their system for a couple of days. Yes, they are going to have great numbers in just a few days. Barring other variables, yes, its that simple, sometimes. I dont think this is rocket science.

Quite frankly, a patient could just go on the restricted diet, and skip the surgery, and achieve similar results... And not that long ago, some of these researchers were practically claiming this same argument: A very low calorie diet could cure type 2 diabetes. 


This article though, quickly sidesteps the discussion and dismisses it without much more than an acknowledgement.


Red Flag #3


The idea that type 2 diabetes begins in the gut is not a new one. It has been, however, a seldom reported one.

More commonly, you see articles speculatively linking the bacteria most known for leading to peptic ulcers (h. pylori), to endocrine disorders (as well as diabetes), and these have been quietly making the rounds since at least 2009, maybe even earlier. Theres even an interesting study dating back to 1999, and involving children with type 1 diabetes, insulin requirements, and the presence of h. pylori. The most recent finding came this month, and it involves h. pylori and its impact on A1C.

The underlying message is clear: bacteria, and inflammation, alter the bodys ability to process glucose -- whether in the stomach, or in the gut.

But are the researchers missing the obvious clues? They mention that in the past, patients with peptic ulcers who had surgeries altering their stomachs, and gut connection, cured their diabetes. Or did they just achieve better control of their diabetes because a.) they were now having to, forcefully, eat far less, and b.) the surgery removed chronic inflammation from bacterial infection (which would have dramatically raised blood glucose levels)?

Other articles, and research, have pointed to a bacterial imbalance in the gut as a trigger to an imbalance in processing glucose, and development of type 2 diabetes, but they do NOT suggest surgery for curing the disease. In fact, they suggest a more preventative method -- receiving gut microbiota transplantation. This seems to me like the less invasive, less dangerous, less costly and time consuming, way to go when it comes to researching a cure. Why are we not investing in this? Why is there such a PUSH for getting this dangerous surgery?

The attempts to also connect this surgery to a potential cure or reversal of type 1 diabetes seem a bit far fetched, and improbable to me, and make me question if this researcher has a proper understanding of the etiology of type 1(a) diabetes -- and that it isnt just an insulin insufficiency scenario. Im pretty sure people need insulin to live, and for many various metabolic functions, and just bypassing a gut mechanism isnt going to make a person insulin independent. Id like to see more than just three sentences in a poorly edited FOX news article, on the matter.

Red Flag #4


Numbers.

These articles always seem to exaggerate diabetes incidence numbers. This one is no exception. It claims that 8.3% of the worlds population has diabetes, and that 11.3% of Americans, have it. Honestly, I dont know where the 11.3% figure came from, with these folks -- but according to the most recent data (released January 26, 2011 -- and not the 2010 date these folks claim) released by the American Diabetes Association, only 8.3% of Americans have diabetes -- and this includes all types, and the undiagnosed. 


Similarly, these folks make these grandiose claims for the remission rates of Roux-en-Y to be 80-85%, and to be incredibly superior to other forms of gastric surgery. But major studies DONT show that.

"New research reports that no procedure for weight loss surgery is any better at treating diabetes than another. The study, presented May 7 at the International Congress of Endocrinology/European Congress of Endocrinology in Florence, Italy, uses a large ongoing study to show that improvements to diabetes in patients undergoing such surgery is likely to be due to the degree of weight loss itself rather than the type of procedure." (http://www.sciencedaily.com/releases/2012/05/120507102225.htm)

And heres a more startling fact...

"Weight loss surgery is not a cure for type 2 diabetes, but it can improve blood sugar control, according to a new study published in the British Journal of Surgery. Whereas some previous studies have claimed that up to 80 per cent of diabetes patients have been cured following gastric bypass surgery, researchers at Imperial College London found that only 41 per cent of patients achieve remission using more stringent criteria." [emphasis added by me] (http://www3.imperial.ac.uk/newsandeventspggrp/imperialcollege/newssummary/news_4-1-2012-13-32-26)

And thats the ticket here, isnt it? What kind of criteria are these folks using to claim someone is cured? What are their A1Cs, now, and what are their average blood glucose numbers like? Ive had folks tell me "I have an A1C in the 6.5% range, so I no longer have diabetes." But wait a minute? Thats the number used to diagnosed diabetes to begin with! 

Hey, but you no longer need medicine (for now, anyway), so you must be cured, right? It sounds so pretty... It sounds like such a good sell.

And because it sounds like such a good sell... I give you:

Red Flag #5

"The cost of the bypass surgery is covered by a grant from Covidien Plc, which makes laparoscopic instruments and surgical staplers." 

Oh, so let me see... the people who profit the most from this surgery are the ones funding a study to tell me how awesome this surgery is, how high a success rate it has (even though it is absolutely not supported by independent studies), and how I will just be so cured.

Hmmmmmmmm. Let me think about that. Fox guarding the hen house much? This reminds me of last year, when the ADA published a study done by the Australian Dairy Association, claiming that milk consumption lowered risk of diabetes.

Of course youre going to tell me its awesome! You want me to buy more of it, and you want me to fall in love with it. You need to make money, too, like everyone else! Its MARKETING.

The problem comes when the money making interests muddle the big picture, and really go against the best interests of the INFORMED patient.

What am I trying to get at, with this blog post? 


Should you avoid gastric bypass? Is it a dangerous alternative?

These are questions you must weigh for yourself... but what I would like to see is for patients to be able to weigh the TRUTH against the hype. NO ONE should promise that surgery will be a success, that it will heal and cure diabetes, or that it will be complication free; but, instead, they must help guide the patient to a point where they can soberly weigh their current health risks against the surgerys very real risks and potential failures. It is easier to accept the roll of the dice when we know that risks are possibilities -- and when we arent lead to believe that this is just a simple, routine procedure, that will fix our woes forever.

More importantly -- the type of lifestyle changes required by these surgeries are far more demanding than say, pursuing a low carbohydrate regimen (like Bersteins Diabetes Solution, or Atkins), or even raw dieting. If a patient fails at these, or simpler life style changes -- when their life is not at stake -- what makes them feel they could do okay with the dietary demands of such a surgery? Because they got two weeks of psychological counseling pre-op? Disordered eating, and compulsion, take years of counseling to improve (much more to fix)!

Additionally, studies have shown that after some time, peoples diabetic symptoms may return, and some folks even regain weight and end up pursuing additional gastric surgeries. I am not entirely sure that the costs of surgery, with its attendant complications, are worth my getting a free pass for a few more years; especially, when I can just give myself that free pass with a more calorie restricted, low carbohydrate diet.

And I dont know about you... but I just like eating food in portions larger than a peanut.