Comment

dose that focused on reducing energy or fat intake, or glycaemic indexing. Variables that were associated with deviation from carbohydrate counting approaches included being from a racial or ethnic minority, being overweight, and having a lower level of parental education. Conversely, being lean and more common use of carbohydrate counting were associated with better glycaemic control.8 The findings of the SEARCH for Diabetes in Youth study suggest that the learning needs of young people, and perhaps adults, vary substantially. Diabetes MNT guidelines address the need for tailoring the counselling approach to the decision making process used to select food on the basis of its carbohydrate content and other variables.1,4 Reducing measurement error with respect to estimating the carbohydrate content of foods needs to be considered in research to improve the efficacy of carbohydrate counting.9 It might be easier to estimate the carbohydrate content of packaged foods, but MNT assessment is intended to address a broader range of nutritional issues that affect overall health such as body weight, physical activity, and dietary pattern. Future research needs to address why some patients need little guidance and seem to use some form of ad-hoc fuzzy logic to adjust their insulin dose to match what they are eating, whereas other patients need complex algorithms to achieve the same glycaemic targets. Studies need to address methods for identifying which patients need more MNT support to achieve treatment goals and which ones need less guidance to adjust their insulin dose to match what they are eating. Dietary constituents and attributes beyond the amount of carbohydrate, which might confound the effects of carbohydrate counting on insulin needs and HbA1c, include the quality of the carbohydrate (glycaemic index,

fibre), fat intake (amount and potentially qualitative via fatty acid composition), and protein (amount and aminoacid composition).10 Research should addresses barriers to achieving treatment goals and translating nutrition information into patient-centred type 1 diabetes MNT guidelines that include other strategies as well as carbohydrate counting. Judith Wylie-Rosett Albert Einstein College of Medicine, Department of Epidemiology and Population Health, 1300 Morris Park Avenue, Bronx, NY 10461, USA [email protected] I declare that I have no conflicts of interest. 1

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Wylie-Rosett J, Albright AA, Apovian C, et al. 2006–2007 American Diabetes Association nutrition recommendations: issues for practice translation. J Am Diet Assoc 2007; 107: 1296–1304. Bell KJ, Barclay AW, Petocz P, Colagiuri S, Brand-Miller JC. Efficacy of carbohydrate counting in type 1 diabetes: a systematic review and meta-analysis. Lancet Diabetes Endocrinol 2013; published online Oct 25. http://dx.doi.org/10.1016/S2213-8587(13)70144-X. Anderson EJ, Richardson M, Castle G, et al. Nutrition interventions for intensive therapy in the Diabetes Control and Complications Trial. The DCCT Research Group. J Am Diet Assoc 1993; 93: 768–72. Wylie-Rosett J, Aebersold K, Conlon B, Ostrovsky NW. Medical nutrition therapy for youth with type 1 diabetes mellitus: more than carbohydrate counting. J Acad Nutr Diet 2012; 112: 1724–27. Nathan DM. Long-term complications of diabetes mellitus. N Engl J Med 1993; 328: 1676–85. DAFNE Study Group. Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE) randomised controlled trial. BMJ 2002; 325: 746. Gilbertson HR, Brand-Miller JC, Thorburn AW, Evans S, Chondros P, Werther GA. The effect of flexible low glycemic index dietary advice versus measured carbohydrate exchange diets on glycemic control in children with type 1 diabetes. Diabetes Care 2001; 24: 1137–43. The NS, Crandell JL, Thomas J, et al. Correlates of medical nutrition therapy and cardiovascular outcomes in youth with type 1 diabetes. J Nutr Educ Behav 2013; published online July 24. DOI:10.1016/j. jneb.2013.06.003. Spiegel G, Bortsov A, Bishop FK, et al. Randomized nutrition education intervention to improve carbohydrate counting in adolescents with type 1 diabetes study: is more intensive education needed? J Acad Nutr Diet 2012; 112: 1736–46. Wheeler ML, Dunbar SA, Jaacks LM, et al. Macronutrients, food groups, and eating patterns in the management of diabetes: a systematic review of the literature, 2010. Diabetes Care 2012; 35: 434–45.

Safety of bariatric surgery

Life in View/Science Photo Library

A recurring scenario in the bariatric surgeon’s office is a 140 kg patient with insulin dependent diabetes, (after 5 years on oral medications), hypertension, and sleep apnoea who says that they are deathly afraid of surgery (or anesthesia) and that they will just “give it another go” with diet and lifestyle modifications. The sad truth is that the assumptions of the patient—and, unfortunately, usually also their physicians—about obesity are wrong. 98

Simply stated, there are no effective dietary or medical therapies for severe obesity (BMI >40).1 First, the assumption that severe obesity is a behavioural or social choice, which can be reversed with a determined patient’s effort, is simply incongruous with medical fact. The recent increase in the prevalence of obesity is not only related to diet choices and portion size—certainly other factors are at play. The second assumption about obesity www.thelancet.com/diabetes-endocrinology Vol 2 February 2014

Comment

that is untrue is that the disease is benign. According to the US National Institutes of Health, obesity and overweight combined are the second leading cause of preventable death in the USA, close behind tobacco use.2 Masters and colleagues3 have recently reported that in the USA obesity alone is the cause of 20% of deaths in women and 15% of those in men. The effects of comorbidities related to severe obesity are even more frightening. In the USA, diabetes is the leading cause of kidney failure, non-traumatic lowerextremity amputations, and new cases of blindness in adults. Diabetes is also a major cause of heart disease and stroke, and is itself the seventh leading cause of death in the USA.4 Sleep apnoea is also malevolent as afflicted patients are 46% more likely to die from any cause, regardless of age, sex, ethnic origin, weight or smoking.5 So, in terms of obesity treatment, what is available in the surgical armamentarium? There are three common bariatric surgeries: laparoscopic adjustable gastric banding, sleeve gastrectomy, and gastric bypass (table). Each of these operations requires general anesthesia, and all are usually done using minimal invasive surgical techniques—ie, laparoscopically. Laparoscopic adjustable gastric banding is a simple surgical procedure, often done as a so-called day case, which consists of an adjustable silicone balloon ring being placed around the upper stomach to restrict passage of food. The band itself is a fixed obstruction, and its size is adjusted by adding fluid to the balloon on an intermittent basis. Although the band is easily removable, it can be challenging to revise to another surgical procedure. Recent literature has shown that, although device-related mortality is low, there are substantial rates of complications that require reoperation, and the proportion of laparoscopic adjustable gastric banding operations is in steep decline.6 Sleeve gastrectomy is an irreversible operation in which most of the reservoir capacity of the stomach (fundus and body) is removed, resulting in substantial sustained weight loss and comorbidity resolution. In view of its technical simplicity, excellent safety profile, and substantial patient acceptance, this surgery has become a very commonly practiced procedure. Complications, such as staple line leak, although infrequent, can be difficult to treat.7 Gastric bypass was first done laparoscopically in the late 1990s, but has been used as a safe and effective www.thelancet.com/diabetes-endocrinology Vol 2 February 2014

weight loss therapy for more than 50 years. Although often, but unjustly, maligned, this operation induces and sustains pronounced weight loss by creating a small proximal gastric pouch, which is anastomosed in a Roux-en-Y fashion to the distal jejunum, thus bypassing the distal stomach and proximal small bowel. Complications are fairly infrequent, and quality of life studies show significant improvement in patients following surgery compared with the preoperative state.11 The discerning reader will ask three questions: is bariatric surgery safe, does it improve comorbidities, and, if so, does this result in prolonged survival? Bariatric surgery is indeed safe. Thanks to improved patient-care protocols and the laparoscopic approach, mortality rates have fallen by 80% in the past decade.12 Mortality risk of bariatric surgery now equals that of hip replacement (0·3%); this is one tenth the mortality risk of coronary artery bypass.13 In fact, when we published our results of 4776 patients in 2009,8 individual types of adverse outcomes related to surgery at 30 days were so rare that we needed to combine them to make a composite endpoint of only 4%. Several high-quality randomised trials have compared the commonly used types of bariatric surgery with medical treatment of diabetes, and have shown high rates of diabetes remission in the surgical arm with little change in the optimally treated medical arm. For

See Series pages 141, 152, 165, and 175

Gastric bypass

Laparoscopic adjustable gastric band

Sleeve gastrectomy

Duration of operation

1–3 h

0·5–1 h

1–1·5 h

Hospital length of stay

2–3 days

0–1 days

0–2 days

Supplements

Multivitamins, iron, calcium

Multivitamins, calcium

Multivitamins, calcium

Weight loss (% of total body weight)

35%

15%

25–30%

Adverse effects

Dumping (Rapid gastric emptying;nausea, cramps, diarrhea)

Vomiting

Nausea, vomiting

Mortality (30 days)

0·34%

0·08%

0·21%

Complications at 3 years (cumulative Leak, infection, rate %) vitamin deficiencies, bowel obstruction (15%)

Band slippage, erosion into the stomach, gastrooesophageal reflux disease, oesophageal dilatation (15%)

Leak, infection, vitamin deficiencies (6%)

3-year reoperation rate

5%

15%

3%

Diabetes improvement or remission (5 years)

50–70%

30–40%

40–50%

Data from Courcoulas and colleagues,6 Hutter and colleagues,7 Flum and colleagues,8 Mingrone and colleagues,9 Sjöström and colleagues.10

Table: Comparison of common bariatric procedures

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example, in a prospective randomised study involving 60 patients, Mingrone and colleagues9 showed that, after 2 years, diabetes remission had occurred in 75% of patients who had undergone gastric bypass versus 0% of patients who had received medical therapy. To the naysayer who scoffs, saying that these results might not be sustained over time, notably obesity-related diabetes is a chronic disease, and 10-year remission rates of 35%10 are not derided by oncologists. In fact, long term glycaemic control is certainly associated with reduced end organ damage from diabetes14 and would probably be considered favourably when weighing up the risk:benefit ratio for surgery by some patients. There is also solid evidence that the decreases in cardiovascular disease, diabetes, and cancer that follow bariatric surgery result in a significant increase in lifespan.15 When we misconstrue severe obesity as a self-induced or behavioural problem, instead of a physiological dysregulation, we are likely to reject surgery as being an inappropriate and overly aggressive solution. We also overestimate the benefits of lifestyle and pharmacological interventions, and can often misinterpret the risk:benefit ratio of these surgical procedures. Certainly, not all patients with diabetes should be deemed surgical candidates, but compliant patients who are resistant to optimum medical treatments ought to have a surgical consultation sooner rather than later in the course of their disease. It is curious that, although convincing data has now been published in top tier, peer-reviewed medical journals, the option of bariatric surgery is still largely ignored by most physicians. As Max Planck stated, “A new scientific truth does not triumph by convincing its opponents and making them see the light, but rather because its opponents eventually die, and a new generation grows up that is familiar with it.”

Alfons Pomp Department of Surgery, Weill Cornell Medical College, New York Presbyterian Hospital, NY 10065, USA [email protected] I declare that I have no conflicts of interest. 1 2

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Appel LJ, Clark JM, Yeh HC, et al. Comparative effectiveness of weight-loss interventions in clinical practice. N Engl J Med 2011; 365: 1959–68. NHLBI Obesity Education Initiative Expert Panel on the Identification, Evaluation, and Treatment of Obesity in Adults (US). Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults. Bestheda; National Institutes of Health, National Heart, Lung, and Blood Institute, 1998. Masters RK, Reither EN, Powers DA, et al. The impact of obesity on US mortality levels: the importance of age and cohort factors in population estimates. Am J Public Health 2013; 103: 1895–1901. Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta: US Department of Health and Human Services, Centers for Disease Control and Prevention, 2011. Punjabi NM, Caffo BS, Goodwin JL, et al. Sleep-disordered breathing and mortality: a prospective cohort study. PLoS Med 2009; 6: e1000132. Courcoulas AP, Christian NJ, Belle SH, et al. Weight change and health outcomes at 3 years after bariatric surgery among individuals with severe obesity. JAMA 2013; 310: 2416–25. Hutter MM, Schirmer BD, Jones DB, et al. First report from the American College of Surgeons Bariatric Surgery Center Network: laparoscopic sleeve gastrectomy has morbidity and effectiveness positioned between the band and the bypass. Ann Surg 2011; 254: 410–20. Flum DR, Belle SH, King WC, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med 2009; 361: 445–54. Mingrone G, Panunzi S, De Gaetano A, et al. Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med 2012; 366: 1577–85. Sjöström L. Review of the key results from the Swedish Obese Subjects (SOS) trial—a prospective controlled intervention study of bariatric surgery. J Intern Med 2013; 273: 219–34. Kolotkin RL, Davidson LE, Crosby RD, Hunt SC, Adams TD. Six-year changes in health-related quality of life in gastric bypass patients versus obese comparison groups. Surg Obes Relat Dis 2012; 8: 625–33. Zhao Y, and Encinosa W. Bariatric Surgery Utilization and Outcomes in 1998 and 2004. Statistical Brief #23. Rockville: Agency for Healthcare Research and Quality, 2007. www.hcup-us.ahrq.gov/reports/statbriefs/ sb23.pdf (accessed Jan 15, 2014). Dimick JB, Welch HG, Birkmeyer JD. Surgical mortality as an indicator of hospital quality: the problem with small sample size. JAMA 2004; 292: 847–51. King P, Peacock I, Donnelly R. The UK Prospective Diabetes Study (UKPDS): clinical and therapeutic implications for type 2 diabetes Br J Clin Pharmacol 1999; 48: 643–48. Sjöström L, Narbro K, Sjöström CD, et al. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med 2007; 357: 741–52.

Quality of life after bariatric surgery See Comment page 98 See Series pages 141, 152, 165, and 175

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Measuring health-related quality of life forms an essential element in the assessment of health outcome after bariatric surgery, and the outstanding improvements in health-related quality of life after surgery are a testament to its broad efficacy. Clinically severe obesity, which generally refers to individuals with a BMI greater than 35 kg/m², is a serious, chronic, relapsing disease that has a major effect on

an individual’s health. Sociodemographic factors, obesity-related comorbid diseases, physical disability, and high levels of stigmatisation and psychological burden generate compounding stressors that make chronic disease management in severely obese individuals challenging.1 Bariatric surgery is the most effective weight loss method; but—as for all chronic disease management—health outcomes are not onewww.thelancet.com/diabetes-endocrinology Vol 2 February 2014

Safety of bariatric surgery.

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