Bariatric Surgery Best for Obese Diabetics
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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