Obesity and Diabetes

Evaluating the Bariatric Surgery Option
A review of available literature
This white paper has been prepared by Ethicon US, LLC, and has not been subject to peer review.

. It is not intended to constitute medical advice or recommendations. depending on their specific weight.Bariatric surgery is used in the treatment of qualifying obese adult patients for significant long-term weight loss. ETHICON is offering this informa- tion in good faith as an overview to published literature in this area and a starting point for further research. Individual results following bariatric surgery may vary. The potential benefits discussed are associated with the patient’s weight loss and other metabolic effects following bariatric surgery. Patients and doctors should review all available information on non-surgical and surgical options in order to make an informed treatment decision. Bariatric surgery may be appro- priate for some patients and not for others. ETHICON manufactures and markets general surgical instruments used in bariatric surgery. and medical history. age. not with the use of the instruments.

3 There are over 40 known obesity-related conditions. Excess free fatty acids impair the function of β-cells in the pancreas. The Bariatric Surgery Treatment Option for the prevalence of diabetes Obesity increases with increasing Traditional approaches to weight loss.5-25 kg/m2.Obesity and Diabetes: Evaluating the Bariatric Surgery Option Introduction Obesity.5 times more likely to die fatty acids.8.2% 2. contributing to with T2DM also are overweight.9 Adults aged 35-59 with a BMI T2DM risk in these patients.5 Prevalence of Obesity-Related Conditions according to BMI 60% 49% 50% 45% 40% 29% 30% 23% 22% 19% 19% 20% 17% 12% 10% 4% 8% 8% 0% Diabetes Hypertension Arthritis Data source: Stommel M. individuals living with obesity suffer from obesity-related health conditions such as type 2 diabetes (T2DM).9 The relative risk of the body may not be able to respond appropriately to normal developing T2DM increases linearly by approximately 25% for or even high circulating levels of insulin. a landmark Swedish study found that on Normal Weight Severely Obese T2DM.2 Often. 14.4% of individuals with BMI diet and physical activity. 75 million adults.10 at high levels.8 The risk for developing the risk for development of T2DM. which are responsible for the secretion According to a National of insulin. Excess adipose tissue derives free between 40 and 50 kg/m2 are 22. decreasing insulin-mediated glucose uptake increasing degrees of obesity Examination Survey in peripheral tissues.14 (NHANES.12 A possible independent risk factor for the development of diabetes. including changes in 14. resulting in increased each additional unit of BMI. so does the risk for developing leads to a decrease of adiponectin release from adipose tissue. diabetes exercise alone would only be able to achieve a sustained presented in only 2. n=4.1 More than one third of the American adult population. are important for a healthy lifestyle.15 Weight loss resulting from behavioral interventions generally leads to a .6 As physiological cause of insulin resistance is a decrease in the abdominal fat mass. BMI 25 BMI 30 BMI 40 BMI 40+ Obesity.18(9):1821-1826.2% degrees of obesity. sleep apnea and arthritis. a 200-pound patient fighting obesity with diet and weight individuals.4.4 As a result. while in normal average.7 More than 90% of individuals which potentially increases insulin resistance. with 15 million people classified as having severe obesity (a body mass index (BMI) of ≥40 kg/m2). hypertension. is now being classified as an epidemic. waist circumference. is classified as having obesity.4%. approximately Evidence has demonstrated that obesity is a major 15% have T2DM and experience insulin resistance.13 For patients with obesity. a chronic disease of substantial public health concern in the United States.11 weight loss of 4 pounds over 20 years.13 This combination prevents the body from using T2DM increases with Health and Nutrition insulin correctly. greater than 40 kg/m2 had However. The Link between Obesity and Diabetes Of the portion of patients who have obesity. which can weaken the body’s sensitivity to insulin from T2DM than those with a BMI of 22. 2010. patients with severe obesity often experience diminished quality of life and increased mortality.205) taken between 1999 and 2004. type 2 diabetes mellitus (T2DM). hyperlipidemia. T2DM begins at a BMI as low as 22 kg/m2.3 This is particularly problematic because when BMI increases so does the prevalence of obesity- related conditions. et al. Obesity often circumference ratio increase. and waist-to-hip cytokine adiponectin in individuals with obesity.

20.31 Ethicon According to America Heart Association Scientific Statement sponsored a Cleveland Clinic randomized clinical trial study from 2011.21 Obesity–related health plus Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy conditions have been resolved in up to 80% of patients.”17 The ADA also supports bariatric surgery as a peptide YY.6%24 analogues) approved by the Food and Drug Administration. The AHA said that - body to regulate itself down to a lower set point for body fat.15 For most patients with severe obesity.2% 26 29.2% 26 60. half of the patients in the RYGB plus medical Gastric Band 55.0% 25 Not enough data Findings indicated that at three years post-surgery with medical therapy.0% 28 Furthermore. of subjects.g. glucagon-like peptide-1.”17 Bariatric surgery has been shown to provide the which showed that uncontrolled diabetes in patients (40% of greatest amount of excess weight loss with greater than 45% whom were on insulin) who are overweight or have obesity one year post surgery compared to 10% or less for lifestyle was managed more effectively with intensive medical therapy and pharmacological treatments. Drug Therapy 11. incretin Diet and Exercise -0.18 metabolic control becomes further impaired. surgery should be considered for adults with BMI ≥ 35 kg/m2 increased satiety. especially if the diabetes is difficult to control with lifestyle and pharmacologic therapy. leptin.15 The body seeks to defend its body T2DM Condition Improvements post Bariatric weight by increasing appetite while lowering the metabolism. “The most clinically relevant impact of surgically induced Following bariatric procedures such as sleeve gastrectomy weight loss compared to medically induced weight loss on and gastric bypass. and even healthier food preferences.0%) without the need for any diabetes medications that is lost as a result of treatment 3 years post-surgery. bariatric surgery produces excess weight loss of +25% at 5 years.19.17 and Type 2 Diabetes.32 .15 Surgery This limits weight loss and promotes weight regain.000 bariatric procedures were performed “Control” of diabetes for this study was defined as HbA1c <6. frequent home glucose Treatment Loss at 3 years Loss at 5 years monitoring.1% 24 -1. 24% of SG patients) Gastric Bypass 71. amylin.29 Both the American Heart has with food and its metabolism. n=150). in 2014 in the US.23 Patients who underwent both medical therapy and either RYGB or SG had greater weight loss than patients who A comparison of weight loss between obesity treatment options received only intensive medical therapy. insulin. and the use of newer drug therapies (e. (ADA) have published statements in support of bariatric surgery has metabolic and hormonal impacts that enable the surgery as a treatment option for T2DM. cholecystokinin. management of diabetes such as T2DM. It has been shown to improve Since weight gain may be caused by some diabetic associated conditions through weight loss. New research indicates Association (AHA) and the American Association of Diabetes that with procedures that alter the stomach or intestine. more patients achieved the glycemic target Excess Weight Loss Excess Weight Loss Surgery at 3 years at 5 years of HbA1c<6. the digestive tract is altered in a way that diabetes mellitus. through metabolic processes that can can be particularly challenging in patients with obesity.16 Many patients experience a decrease in hunger. weight management.”30 Bariatric surgery is the most effective long-term treatment option for qualifying patients with obesity. or in some cases medications and insulin therapy. including lifestyle Average Weight Average Weight counseling.22 (SG) surgeries. and possible diabetes treatment option stating that “Bariatric adiponectin. patient. is the ability of the former to completely decreases appetite due to modification of gastrointestinal reverse established diabetes mellitus in a large percentage (GI) hormone levels including ghrelin.5% 28 therapy group (58%) and a third of patients in the SG plus Percent average weight loss = % of total body weight lost as a result of treatment medical therapy group (33%) achieved glycemic control Percent excess weight loss= % of body weight in excess of the ideal body weight (HbA1c<7.0% (38% of RYGB patients.0% 27 49. than with intensive medical treatment alone. Approximately 179..32 Sleeve Gastrectomy 66.28 Bariatric Bariatric surgery helps to reset the body’s ability to effectively surgery is an effective intervention for severe obesity and manage weight by altering the complex relationship the body may reduce the risk for diabetes.5% 28 than did patients with medical therapy alone (5%).“starvation response”. “it is clear that obesity surgery today offers the only named the Surgical Therapy and Medications Potentially effective long-term treatment option for the severely obese Eradicate Diabetes Efficiently study (STAMPEDE. as complement or replace the need for other treatments.

medication reduction with no difference in blood pressure or significant improvement in quality of life with improved scores LDL. patients demonstrated resolved (78. 201432 shown to have a greater metabolic response.0% even in patients requiring insulin pre-surgery.39 Procedures 58% 33% 9% 5 years post op which induce weight loss without realignment of the small Reductions in 85. conditions.40 With excess weight loss ranging from 23% for laparoscopic adjustable gastric Additional studies have shown that 12 months after bariatric banding to up to 95% for biliopancreatic diversion with surgery. Furthermore there were no cardiovascular events or on the validated SF-36 psychometric tool. It can therefore be argued that bariatric surgery for In 2013 the British Medical Journal reported on “Bariatric the severely obese with Type 2 diabetes should be considered Surgery versus non-surgical treatment for obesity: a early as an option for eligible patients. The results were that surgery was levels of fasting plasma glucose were significantly lower in found to be superior to medical treatment in terms of weight patients undergoing medical therapy plus either RYGB (85.33 Since the publication of STAMPEDE. The probability of achieving T2DM remission were also seen in patients undergoing medical therapy plus post bariatric surgery is related to the disease severity (time either RYGB or SG. Triglycerides.0 mg 6. HbA1C control.1%)35 or duodenal switch there is wide variation on the effect of improved (86. mg∙dL-1) or SG (46.37 surgical and non-surgical No longer needed Substantially reduced Retrospective Matched Cohort Analysis of T2DM patients with and without bariatric surgery .0 mg bowel. fat mass.”(International Diabetes Foundation). the DiaRem score and ABCD score.5 loss.18 such as decreased weight. waist circumference. HDL. The procedures that have been New England Journal of Medicine – May. can median fasting plasma glucose dL dL dL also facilitate diabetes control and remission. insulin usage was reduced by 26% of surgical patients compared to only 9% of patients that T2DM Elimination of Medications comparing did not have surgery.0% 3 years procedure.5% 0% diabetes meds long term38 and has been shown to induce T2DM control HgA1c<7. This report included 11 studies.36 and medication use for T2DM was reduced early remission of diabetes may occur within days after by 75%.6%) diabetes and other obesity-related bariatric procedures to T2DM remission. and are most group included ONLY intensive medical therapy. but to a lesser Of note.38 In some patients. at 5 years post-surgery.38 Gastric bypass provides less nutritional risk post op without 35. In a retrospective matched cohort analysis from surgery and before major weight loss has been achieved.Compared with the reduction observed in the medical controlled trials”. offer a higher HgA1c<6. 796 patients therapy alone group (6.0 mg∙dL-1) procedures. since diagnosis and/or insulin use) at the time of surgery and the dramatic impact of bariatric surgery on T2DM has been bariatric procedure performed. blood pressure. rather than being held systematic review and meta-analysis of randomized back as a last resort. reductions in the median with a BMI between 27-53. quality of life measures and health outcomes were accomplished with a concurrent. Tools for predicting probability documented in numerous other randomized trials.0 mg∙dL-1).41 . T2DM remission. The control degree than the metabolic procedures.2015 Gastric bypass 84% 93% With Surgery Without Surgery Insulin Usage Reduced by 26% Reduced by 9% “Residual hyperglycemia is easier to manage following bariatric surgery. such as sleeve gastrectomy and gastric banding.5 mg 46.32 These improved remission of metabolic syndrome. HbA1C. T2DM remission can be related to the bariatric Cleveland Clinic STAMPEDE Results as reported in the procedure performed. Other outcomes.5% 24.0% probability of T2DM remission but also a higher probability 3 years post op 38% 24% 5% of medically important nutritional deficiencies following the HgA1c<6. all options included intensive medical therapy. namely the RYGB SG Control biliopancreatic diversion and duodenal switch. death after surgery. effective early in the disease process. and triglyceride levels.34 of remission have been developed.38 2015. Diabetes control in obese patients can be facilitated by as well as increased high-density lipoprotein cholesterol bariatric surgery. lean mass.

While these changes may help to sustain a lower as their obesity-related conditions improve.44 In a study on weight set point. inflammation of the gallbladder.28 Bariatric blood vessels. surgery in about two years for laparoscopic surgery and in and late choledocholithiasis. interventions are not effective. specifically lower costs associated with reduced medications and a to the processes that regulate energy balance and metabolic reduced interaction with all levels of the healthcare system function.49 The analysis covered include gastric perforation. leak or fistula.93%)52 surgeries. as well as lowering the risk for T2DM. intra-abdominal abscess. nausea/vomiting. dilated pouch. the type of bariatric surgery.55 The average T2DM medication usage dropped by half in 12 months. pulmonary research. nutritional or vitamin uncontrolled diabetes. as well as the surgeon’s and anesthesiologist’s post-surgery and by 78% fifteen years post-surgery. Bariatric vomiting. and band erosion. risk of developing T2DM was reduced by 96% two years and age. such as adverse reactions to is a viable alternative when diet exercise and other behavioral medications. there was an 88% cost savings for T2DM circulating bile acids.30 cholecystectomy (0. first four years.7%)51 and hip replacement (0.1%. incisional hernia. dysphagia. Cost Effectiveness of Bariatric Surgery malnutrition.Bariatric surgery may also reduce the risk for diabetes in The overall likelihood of bariatric surgery major complications patients with pre-diabetes. and related cost savings for antidiabetic.58 Bariatric 0. port rotation or leak. distribution of bacteria in the gut medications at 12 months following gastric bypass45 and microbiota. It is also important to advise patients on the need for long term follow up.50 which is less than that have a high risk for diabetes. Bariatric surgery All surgeries have risks. Bariatric surgery has been bleeding. According to outcomes data from surgery can be considered for patient with obesity that Bariatric Surgery Centers of Excellence.7% 51 0. The success of bariatric surgery is highly correlated Since bariatric surgery is a life changing event it is important with the experience of both the surgeon and the health to ensure patients are well informed.43 deficiencies. and altered vagal and sympathetic neural 80%-99. the surgery port-site infection.46 activity. band obstruction. patients may have substantially cause changes to the autonomic nervous system.3%.56 surgery appears to be a clinically effective and cost-effective intervention for moderately to severely obese people Identifying a Candidate for Bariatric Surgery compared with non-surgical interventions.56 Sleeve gastrectomy may be associated Care (AJMC).48 According to the American Journal of Managed pouch dilation. stricture. Clinical Mortality Rate for Surgical Procedures evidence suggests that the overall risks of severe obesity Bariatric Surgery Cholecystectomy Hip Replacement often outweigh the risks for bariatric surgery. and up to five years of post-surgical care.42 experience.57 Gastric banding risks can about four years for open surgery. nausea/ itself. delayed gastric emptying. the patient’s medical condition. bariatric surgery are already diagnosed with T2DM. malposition. internal/incisional hernia. splenic injury. bowel injury or antihypertensive and dyslipidemia agents continue through obstruction.7% cost savings following sleeve gastrectomy. blood clots.93%52 surgery results may vary and surgery may or may not be . that are pre-diabetic or has an overall mortality of about 0. a peer-reviewed journal on health outcomes with gastric leak. gallstones. General risks associated with bariatric surgery Bariatric surgery has been effective for the treatment of include a failure to lose weight. they also could induce changes to patients with T2DM. motivated and center. cognizant of the operative risk. problems breathing.47 Each type of bariatric surgery is associated with its own risks. GERD. According to the Swedish Obesity is 4. inadvertent injury to nearby organs and shown to produce +25% weight loss at 5 years.54. band or six months of pre-surgical evaluation and care. marginal ulcer/gastritis and stenosis. and six years. Bariatric surgery can be considered for weight reduction in patient that are 18 years of older with a BMI of >40 or Bariatric Surgery Risks ≥35 with an obesity related condition. health insurers recover their costs for bariatric embolism. Bariatric surgery may also Following bariatric surgery. in subjects without diabetes at baseline. Risks related to gastric bypass may include The cost of surgery may begin to be recouped within the nutrient deficiency.1%50 0. anastomotic stenosis.53 The risk for serious complications depends on the Study (SOS). and weight regain. problems with anesthesia. even death.

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