Gerald Hurowitz, M.D.·Published 27 March 2012·10 min read
Key points
Bariatric surgery improves glycemic control better than optimal medical therapy alone for obese patients with type 2 diabetes, two randomized trials determined.
The STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) trial was presented at the American College of Cardiology meeting in Chicago in conjunction with NEJM publication.
Your diet changes immediately after bariatric surgery.
Price for the different types of bariatric surgery range from $18,000 to $35,000.
Bariatric surgery improves glycemic control better than optimal medical therapy alone for obese patients with type 2 diabetes, two randomized trials determined.
Hemoglobin A1c levels normalized to under 6% by 1 year for 42% of patients who got gastric bypass surgery and 37% who got sleeve gastrectomy compared with 12% on intensive medical therapy alone (P=0.002 and P=0.008), Philip R. Schauer, MD, of the Cleveland Clinic, and colleagues reported in the STAMPEDE trial.
After 2 years in a second trial, diabetes went into remission with fasting glucose under 100 mg/dL and A1c under 6.5% off medication in 75% of gastric bypass patients and 95% of biliopancreatic diversion patients compared with none on conventional medical therapy.
Metabolic control also improved more in the surgery groups of both trials, appearing online in the New England Journal of Medicine.
"Although type 2 diabetes has been the domain of physicians, surgeons may now be able to claim greater success in achieving improved metabolic control," an accompanying editorial suggested, calling the results likely practice changing.
These two studies provide evidence that in obese patients with type 2 diabetes, surgery can be more effective that either standard or intensive medical treatment alone.
Point out that in both studies, bariatric surgery (gastric bypass, biliopancreatic diversion or sleeve gastrectomy) induced remission and was associated with a significant improvement in metabolic control over and above medical therapy, whether conventional or intensive.
Longer term and larger studies are needed to prove a durable benefit and whether the results would be as good in routine practice, noted editorialists Paul Zimmet, MD, PhD, of the Baker IDI Heart and Diabetes Institute, Melbourne, Australia, and K. George M.M. Alberti, DPhil, of King's College Hospital in London.
Bariatric Surgery is a procedure performed on people who are dangerously obese, for the purpose of losing weight. This surgery is performed on the stomach and intestine causing a reduction of the patient's food intake. It changes the anatomy of your digestive system to limit the amount of food you can eat and digest. Results from this obesity surgery are significant long-term weight loss, recovery from diabetes, improvement in cardiovascular risk factors, and a reduction in mortality. After this surgery, resuming your normal life will require changes in your lifestyle.
Although Bariatric surgery requires a in general hospital stay of 1-2 days it is a permanent procedure that requires a lifetime commitment to maintaining a healthy lifestyle. Benefits of bariatric surgery are not limited to weight loss, but can help improve your overall health, well-being and self-esteem. The National Institutes of Health recommend bariatric surgery for obese people with a BMI of at least 40, and for people with BMI 35 and serious coexisting medical conditions such as diabetes. Bariatric surgery is an excellent alternative for people who cannot lose significant weight through exercise and dieting and whose general health is compromised.
Written and revised by
Gerald Hurowitz, M.D.
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"Meanwhile, the success of various types of bariatric surgery suggests that they should not be seen as a last resort," they wrote. "Such procedures might well be considered earlier in the treatment of obese patients with type 2 diabetes."
American Experience
The STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) trial was presented at the American College of Cardiology meeting in Chicago in conjunction with NEJM publication.
Eating After Bariatric Surgery
Your diet changes immediately after bariatric surgery. You are restricted to a clear liquid diet (foods such as clear broth, diluted fruit juices or sugar-free gelatin desserts). This diet is continued until the gastrointenstinal tract has recovered from the bariatric surgery, generally one-three days. The next stage is a bland diet consisting of blended or pureed foods for at least two weeks. (This diet may consist of skimmed milk, cream of wheat, a small pat of margarine, protein drinks, cream soup, pureed fruit and mashed potatoes with gravy).
Post surgery, overeating is curbed because exceeding the capacity of the stomach causes nausea and vomiting. Diet restrictions after recovery from this surgery depend in part on the type of surgery. Many patients will need to take a daily multivitamin pill for life to compensate for reduced absorption of essential nutrients after their surgery. Because patients cannot eat a large quantity of food, physicians typically recommend a diet that is relatively high in protein and low in carbohydrates and alcohol. A controlled diet after your bariatric surgery will also enhance your changes of greater weight loss and helps you achieve a healthier lifestyle.
It included 150 obese patients with a body mass index of 27 to 43 kg/m2 (mean 36, 34% under 35 kg/m2) and uncontrolled diabetes with a hemoglobin A1c over 7.0% (mean 9.2%) randomized to Roux-en-Y surgery or sleeve gastrectomy or medical therapy alone.
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All patients got intensive medical therapy according to American Diabetes Association guidelines with lifestyle counseling, weight management (recommended to include Weight Watchers), and newer diabetes drugs, such as the incretin analogues.
Glycosylated hemoglobin levels fell rapidly in the first 3 months after surgery. By 1 year, they reached a mean 6.4% after gastric bypass and 6.6% after sleeve gastrectomy compared with 7.5% with medical therapy alone (P<0.001 and P=0.003).
Bariatric Surgery Contraindications Contraindications to bariatric surgery include illnesses that greatly reduce life expectancy and are unlikely to be improved with weight reduction, including advanced cancer and end-stage renal, hepatic, and cardiopulmonary disease.
Patients who are unable to understand the nature of bariatric surgery or the behavioral changes required afterward, including untreated schizophrenia, active substance abuse, and noncompliance with previous medical care, are also considered contraindications to bariatric surgery.
For the primary endpoint of a glycosylated hemoglobin under 6.0% at 1 year, the two bariatric surgery groups came up equal (P=0.59), though all who achieved that target in the gastric bypass group did so off diabetes medications versus 28% in the sleeve gastrectomy group.
Laparoscopic Gastric Bypass More than 100 million Americans (65% of the adult population) are overweight. Obesity is the second leading cause of preventable death in the United States after smoking. Annually, obesity-related diseases account for 400,000 of premature deaths. A combination of genetics, environmental issues, and behavioral factors may contribute to the condition. Consumption of high-calorie foods, consumption of too much food, and a sedentary lifestyle all work together to create this condition. Obesity is associated with the development of diabetes mellitus, hypertension, dyslipidemia, arthritis, sleep apnea, cholelithiasis, cardiovasculardisease, and cancer. Morbid obesity is defined assevereobesitythatthreatensone’shealth and can shorten lifespan.
Obesity can be treated medically and surgically. Medical treatment for obesity is difficult, because the amount of weight lost is small and patients tend to regain most of the weight. Operations designed to result in significant and long-lasting weight loss in patients who are severely obese are called bariatric surgery. The term bariatric surgery is derived from the Greek words baros (weight) and iatreia (medical treatment). Laparoscopic gastric bypass surgery, described here, is one such surgery. It involves creating a gastric pouch.
Body mass index (BMI) describes relative weight for height and correlates significantly with an individual’s total body fat. BMI is based on height and weight and applies to adults of both sexes. BMI is calculated as follows: BMI equals weight in kg/height in m2 or weight in lb/height in square inches.
Not surprisingly, weight loss after gastric bypass and sleeve gastrectomy exceeded that of medical therapy alone over 1 year (-64.8 and -55.3 lb versus -11.9 lb, both P<0.001).
Gastric bypass cut weight as well as BMI significantly more than sleeve gastrectomy (P=0.02 and 0.03, respectively).
"Reductions in the use of diabetes medications occurred before achievement of maximal weight loss, which supports the concept that the mechanisms of improvement in diabetes involve physiologic effects in addition to weight loss, probably related to alterations in gut hormones," Shauer's group noted.
Medication use to control glucose, lipids, and blood pressure fell significantly after both surgeries but increased with medical therapy alone.
Metabolic syndrome and insulin resistance also improved more with the bariatric procedures.
No patients died or had a life-threatening complication, though four patients required additional surgical interventions.
The study wasn't powered to look for differences between the surgical arms or for clinical outcomes, though cardiovascular risk factors did improve.
Limitations included the short follow-up and the open-label assessment of patients at a single center.
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Italian Experience
The second trial, led by Geltrude Mingrone, MD, of the Catholic University of Rome, was likewise a single-center, unblinded trial randomizing patients to gastric bypass, biliopancreatic diversion, or conventional medical therapy alone by a team comprised of a diabetologist, a dietitian, and a nurse.
The 60 participants had a BMI of at least 35 kg/m2 and diabetes of at least 5-years duration with an hemoglobin A1c of 7.0% or more (mean 9%).
The likelihood of a diabetes remission by 2 years was 7.5 times higher for the gastric bypass group and 9.5 times higher for the biliopancreatic-diversion group even assuming the best case scenario that the two medication-group patients who dropped out had a diabetes remission (both P<0.001).
Bariatric Surgery Cost & Insurance Coverage
Bariatric surgery can be complex and costly. Price for the different types of bariatric surgery range from $18,000 to $35,000. The cost of bariatric surgery generally comprises the pre-op lab and X-ray fees, anesthesia, hospital facility, and surgeon's fee. These costs vary based on the extent of the procedure and length of recovery. Post surgery costs are additional, such as for dietary plans, a fitness regimen, behavioral modification, nutritional supplementation, and body contouring surgeries to remove excess skin.
Health insurance providers are beginning to cover some or all of the costs of this surgery if medical necessity is established by your doctor and if you meet the National Institutes of Health requirements. Most cases of chronic morbid obesity (especially with a body mass index above 40) are covered by insurance if your doctor informs the insurance company that the surgery is medically necessary and provides appropriate documentation, including records of your doctor-supervised attempts to lose weight such as drug therapy and group therapy.
Coverage of bariatric surgery is also more likely if your doctor demonstrates that you suffer comorbidities such as diabetes or heart disease.
Your doctor can help you put together a strong case that will improve your chances of insurance coverage. Coverage varies among insurance carriers. If the initial attempt to authorize coverage for bariatric surgery is denied, you can appeal the decision; you should initiate your appeal immediately. Aftercare insurance reimbursements for a dietician, psychologist, exercise program and nutritional supplements such as vitamin B12 injections may be minimal, if covered at all.
Average reduction in hemoglobin A1c from baseline was 43% in the biliopancreatic-diversion group and 25% in the gastric-bypass group compared with just 8% in the medical therapy group, with all comparisons statistically significant.
Weight reductions came out similar at 2 years between surgery types at 33% to 34% of body weight from baseline compared with just 5% on medical therapy alone (both P<0.001).
BMI dropped from a mean of 45 down to 29 kg/m2 in both surgery groups but from 46 to 43 kg/m2 in the medical-therapy group.
But the glycemic benefit appeared independent of both weight loss and preoperative BMI, the researchers noted.
Lipids and blood pressure also improved more with bariatric surgery.
No patients died with bariatric surgery, but there was one case of an incisional hernia requiring reoperation 9 months later with biliopancreatic diversion and one intestinal obstruction requiring reoperation 6 months after gastric bypass. Two medical-therapy group patients had persistent diarrhea that resolved with substitution of another drug in place of metformin.
Limitations included the small sample size and lack of power for safety and clinical endpoints.
Bariatric surgery isn't without hazards and remission may not be a cure, but it is gaining recognition in management of diabetes, the editorialists noted.
International Diabetes Federation now calls it appropriate for obese patients with type 2 diabetes not getting to glucose control targets with available medical therapy, especially with concomitant hypertension or other major coexisting illnesses.
"The final question, which is as yet untested, is whether bariatric surgery is suitable for all obese patients with type 2 diabetes, even those with a lower body-mass index," they wrote.
The STAMPEDE trial was supported by a grant from Ethicon Endo-Surgery, a grant from the National Institutes of Health, and LifeScan. Schauer reported receiving payment for board membership from Ethicon Endo-Surgery, Surgiquest, Barosense, RemedyMD, and Stryker; consulting fees from Ethicon Endo-Surgery, Stryker, Gore, and Carefusion; payment for expert testimony from Physicians Review of Surgery; lecture fees from Ethi-con Endo-Surgery, Allergan, Cinemed, and Quadrant Healthcare; a patent for a medical device to enhance weight loss in codevelopment with the Cleveland Clinic; royalties from Springer; an equity interest in Intuitive Surgical, Barosense, Surgiquest, and RemedyMD; and institutional grant support from Ethicon Endo-Surgery and Bard Davol. Mingrone's study was funded by the Catholic University of Rome. Mingrone reported having no conflicts of interest to disclose. Zimmet and Alberti reported having no financial relationships with industry to disclose. Primary source: New England Journal of Medicine Source reference: Schauer PR, et al "Bariatric surgery versus intensive medical therapy in obese patients with diabetes" N Engl J Med 2012; DOI: 10.1056/NEJMoa1200225.
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