Yesterday, the New England Journal of Medicine (NEJM) published two important and revolutionary studies examining the surgical management of diabetic patients.  Both studies compared bariatric surgery with conventional medical treatment of diabetes in obese patients.  As the NEJM often does with important studies, an editorial followed.  These significant studies showed some dramatic results in glycemic control in diabetic patients.  However, should all diabetics go under the knife for management of their uncontrolled blood sugar?
 

A Brief Review of Type II Diabetes:

Type II diabetic patients experience insulin resistance, which is basically the body’s need of higher levels of insulin to lower blood sugar levels.  As discussed previously, insulin works to lower serum glucose levels after we consume foods that raise blood sugar, like carbohydrates, as high blood sugar levels are toxic and can even be acutely fatal.  When blood sugar levels remain elevated for extended periods of time, our body secretes more and more insulin, and eventually, it stops working as well (insulin resistance).  As a result, medications such as metformin must be given, and eventually even insulin itself must be injected in these patients to lower blood sugar levels.  If blood sugar remains high, it leads to weight gain, blindness, heart attacks, strokes, and a plethora of other problems.  Such strategies work in less than half of all patients¹ to achieve target blood sugar levels, and all patients progressively get worse as this treatment is by no means curative.
 
 

Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes:

The first trial randomized patients to intensive medical therapy versus bariatric surgery, including Roux-enY gastric bypass and sleeve gastrectomy².  Both procedures basically decrease the size of the stomach and/or allow food to pass by (or “bypass”) digestion.  Intensive medical treatment in this study consisted of counsel by a diabetes educator and psychologist, and patients were encouraged to join Weight Watchers.  All patients received lifestyle counseling and glucose monitoring with intense medical therapy.  The primary goal of the study was to see which treatments could get more patients to the target goal of a glycated hemoglobin level of 6% at 1 year.  As sugar levels in the body rise, they bind (or become glycated) to hemoglobin in our blood and measurement of this can track blood glucose levels.  This value correlates to several months’ worth of blood sugar levels and can help the physician to accurately predict where the patient’s blood sugar level remains on average.
 
The Results:
As expected, weight loss was markedly increased in the surgical arms, with both groups dropping their weight by about 25%, while the medical group experienced only a 5% weight loss.  However, glycated hemoglobin dropped significantly in both surgical groups by about 40% while the medical management group only decreased by 12%.
 
While follow-up was short at 12 months, these results illustrate the potential of bariatric surgery to “cure” diabetic patients.  However, long-term toxicity remains unknown, though the initial results for this treatment modality appear favorable.
 
 

Bariatric Surgery vs. Intensive Medical Therapy in Obese Patients with Diabetes

The next study, similar to the first, randomized patients to surgery or medical management.  The interesting twist with this study is the fact that surgery consisted of gastric bypass as above; however, biliopancreatic diversion (which removes part of your stomach and causes food to bypass your duodenum and pancreatic ducts) was a surgical option in this study³.  This procedure works differently than the bariatric procedures that often decrease the size of the stomach (therefore decreasing the ability to eat large amounts of food), by bypassing an area of the stomach that aids absorption of food.
 
The Results:
The results revealed remission of diabetes occurred in 75% of the gastric-bypass patients, but in a remarkable 95% of the diversion patients.  Interestingly, they also found that diabetic control was independent of weight loss, so it was not merely a factor of patients solely losing weight from the procedures.
 
 

Caveman Doctor’s Take:

First and foremost, Caveman Doctor is unsure why anyone would undergo surgery unless absolutely necessary, like when he shot his cousin in the arm with an arrow by mistake during a hunt.  However, those were the olden days (about 1,000,000 BC) and he understands that times have changed and the issues modern man and woman face are much different than those of the caveman.  Caveman Doctor’s first thought is maybe it would be better to try to cure diabetes naturally, by avoiding the foods that cause it.  Caveman Doctor also has noticed that nobody in his time had diabetes because they ate the foods that were presented to them by Nature.  Caveman Doctor was also shocked to hear that recently even children have diabetes, as his people never even saw an overweight child until a couple hundred years ago.
 
Any study that can randomize patients to a surgical and non-surgical group is impressive.  In randomized studies, patients agree to participate and are then allocated to a treatment arm.  To have patients agree to receive two different types of medications is complicated in itself, but randomizing them to medicine versus surgery is extremely difficult.  Secondly the results of decreased weight and blood glucose levels are impressive, but hardly unexpected in these populations.  Finally, and most importantly, to those that like to treat diseases without surgery or medical intervention if possible, the real question remains:
 
Does this say more about bariatric surgery options or less about current medical care for diabetic patients?
 
While surgery may clearly be indicated in individual cases, applying gastric bypass to all obese patients with diabetes is a tactic that I would approach with extreme trepidation.  First off, we don’t know the long-term effects of such procedures and if they will cause more problems down the road.  For instance, biliopancreatic diversion results in the malabsorption of fat, calcium , vitamin D, low protein levels in the body (hypoalbuminemia).  Worse-off, the deficiencies often persist even with vitamin and nutrient supplementation, nearly guaranteeing medical issues in the future.  Also, medicine and drug intervention is not curative and only delays the inevitable: more medications.  This puts the focus back on diet, exercise, and non-medicine health and weight management – and that’s where we have to take a closer look at these studies. 
 
Programs for diet and lifestyle modification in the first study included Weight Watchers, while the second group prescribed the traditional reduced overall energy and fat intake (fat < 30%, saturated fat <10%), increased fiber, and at least 30 minutes per day of brisk walking.  These eye-brow raising details shed some light on the “intervention” in these studies.  While no official studies exist to my knowledge, I have read some reports putting Weight Watcher’s success rate in the single digits.  As for the low-fat recommendations, many randomized trials and high-level evidence already show how such recommendations not only do not work, but are vastly inferior to the opposite approach of low-carbohydrate, high-fat diets^4-17.  Even the editorial article on both of these studies states that “lifestyle measures should be first line treatment”, however, they also note that each current medical algorithm for diabetes “occurs because the preceding recommendation has failed, with the path finally ending with the administration of insulin…a frequent outcome of therapy is weight gain”¹⁸.  Maybe it’s time to change the recommendations and set patients on a new “algorithm” that doesn’t involve recommending foods and dietary strategies that don’t work and may actually cause the problem in the first place.
 
If Maimonides, who once famously quoted: “No disease that can be treated by diet should be treated with any other means” were still alive, I am sure he would have a comment or two for a study comparing a dietary intervention that we know is unsuccessful (and possibly even leads to diabetes) to surgery.
 
I applaud the authors for their study design and results, but as long as we use poor dietary and lifestyle interventions that are proven as ineffective, the non-surgical and even non-medical treatment of obesity and diabetes will always fail.
 
 

In Conclusion:

1. Current medical therapy is ineffective for the treatment of diabetes and obesity, and if anything, delays the inevitable.
2. Current dietary and lifestyle recommendations are ineffective for the treatment of diabetes and, if anything, add to the problem.
3. Bariatric surgery, at least short term, results in improved diabetic control and weight loss.
4. As long as we use ineffective strategies for weight control and diabetes, we will likely see many studies in the future favoring medical and surgical intervention for these disorders.
5. Instead of looking for surgical fixes that may cause further issues in the future, it may be efficacious to revisit non-medical interventions.

 
These were both excellently designed studies and the results will give both doctors and patients that require surgical intervention increased data on these procedures.  Defining who actually requires surgical intervention will remain a difficult task.  While every case is individualized and surgery may be needed in some situations, perhaps overall it would be better to use more natural dietary methods and non-surgical techniques.
 
Also, perhaps it would make more sense to avoid the foods that raise blood sugar in the first place, such as sugar and carbohydrates, as opposed to taking medicines that don’t solve the underlying issue or undergoing surgery that removes or bypasses part of your GI tract.  While these may be complicated medical issues, even a caveman can understand that eating less carbohydrates and sugar results in less carbohydrates and sugar in our blood and less diabetes in the first place.
 

 

References:

1.            Saydah SH, Fradkin J, Cowie CC. Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. Jama. Jan 21 2004;291(3):335-342.

2.            Schauer PR, Kashyap SR, Wolski K, et al. Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. New England Journal of Medicine. 2012;366(17):1567-1576.

3.            Mingrone G, Panunzi S, De Gaetano A, et al. Bariatric Surgery versus Conventional Medical Therapy for Type 2 Diabetes. New England Journal of Medicine. 2012;366(17):1577-1585.

4.            Hite AH, Berkowitz VG, Berkowitz K. Low-carbohydrate diet review: shifting the paradigm. Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition. Jun 2011;26(3):300-308.

5.            Forsythe C, Phinney S, Feinman R, et al. Limited Effect of Dietary Saturated Fat on Plasma Saturated Fat in the Context of a Low Carbohydrate Diet. Lipids. 2010;45(10):947-962.

6.            Forsythe C, Phinney S, Fernandez M, et al. Comparison of Low Fat and Low Carbohydrate Diets on Circulating Fatty Acid Composition and Markers of Inflammation. Lipids. 2008;43(1):65-77.

7.            Volek J, Phinney S, Forsythe C, et al. Carbohydrate Restriction has a More Favorable Impact on the Metabolic Syndrome than a Low Fat Diet. Lipids. 2009;44(4):297-309.

8.            Buscemi S, Verga S, Tranchina MR, Cottone S, Cerasola G. Effects of hypocaloric very-low-carbohydrate diet vs. Mediterranean diet on endothelial function in obese women*. European Journal of Clinical Investigation. 2009;39(5):339-347.

9.            Foster GD, Wyatt HR, Hill JO, et al. A randomized trial of a low-carbohydrate diet for obesity. The New England journal of medicine. May 22 2003;348(21):2082-2090.

10.          Gannon MC, Nuttall FQ. Effect of a High-Protein, Low-Carbohydrate Diet on Blood Glucose Control in People With Type 2 Diabetes. Diabetes. September 1, 2004 2004;53(9):2375-2382.

11.          Gardner CD, Kiazand A, Alhassan S, et al. Comparison of the Atkins, Zone, Ornish, and LEARN diets for change in weight and related risk factors among overweight premenopausal women: the A TO Z Weight Loss Study: a randomized trial. Jama. Mar 7 2007;297(9):969-977.

12.          Keogh JB, Brinkworth GD, Noakes M, Belobrajdic DP, Buckley JD, Clifton PM. Effects of weight loss from a very-low-carbohydrate diet on endothelial function and markers of cardiovascular disease risk in subjects with abdominal obesity. The American journal of clinical nutrition. Mar 2008;87(3):567-576.

13.          Samaha FF, Iqbal N, Seshadri P, et al. A low-carbohydrate as compared with a low-fat diet in severe obesity. The New England journal of medicine. May 22 2003;348(21):2074-2081.

14.          Seshadri P, Iqbal N, Stern L, et al. A randomized study comparing the effects of a low-carbohydrate diet and a conventional diet on lipoprotein subfractions and C-reactive protein levels in patients with severe obesity. The American journal of medicine. Sep 15 2004;117(6):398-405.

15.          Shai I, Schwarzfuchs D, Henkin Y, et al. Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet. The New England journal of medicine. Jul 17 2008;359(3):229-241.

16.          Stern L, Iqbal N, Seshadri P, et al. The effects of low-carbohydrate versus conventional weight loss diets in severely obese adults: one-year follow-up of a randomized trial. Annals of internal medicine. May 18 2004;140(10):778-785.

17.          Yancy WS, Jr., Olsen MK, Guyton JR, Bakst RP, Westman EC. A low-carbohydrate, ketogenic diet versus a low-fat diet to treat obesity and hyperlipidemia: a randomized, controlled trial. Annals of internal medicine. May 18 2004;140(10):769-777.

18.          Zimmet P, Alberti KGMM. Surgery or Medical Therapy for Obese Patients with Type 2 Diabetes? New England Journal of Medicine. 2012;366(17):1635-1636.
 
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