Surgery for Type 2 Diabetes with Obesity?

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Who would have thought that the most effective available treatment of a metabolic medical disease (that is, type 2 diabetes) could be a surgical solution? A new study in JAMA showed that patients who have type 2 diabetes and who are obese, were far more able to come off their diabetic medications than those who were treated by non-surgical means.

From Melbourne, Australia, an article titled "Adjustable Gastric Banding and Conventional Therapy for Type 2 Diabetes - A Randomized Controlled Trial" is published in the January 23, 2008 of the Journal of the American Medical Association (JAMA). The aim of the study is to determine if weight loss surgery resulted in better control of type 2 diabetes than medical (non-surgical) approaches to weight loss and diabetes control. Among 55 patients who completed the follow-up (out of 60 patients), remission of type 2 diabetes was achieved by 73% in the surgical group and 13% in the non-surgical group. In this study, the surgical procedure was laparoscopic adjustable gastric banding (Lap Band). Remission meant being able to keep normal diabetic blood tests while not taking diabetes medications anymore. Please notice that the participants' BMI was more than 30 and less than 40. So, the surgeons accepted lower BMI than the usual cut-off of BMI of 35 that is mostly recommended. Furthermore, the study excluded BMI above 40.

This study adds to other pointers from previous research. Dr. Henry Buchwald in his frequently quoted study: "Bariatric Surgery: A Systematic Review and Meta-analysis" reported that weight loss surgery resulted in complete resolution of type 2 diabetes in 76.8% of patients. To my knowledge, not a single conventional non-surgical treatment of diabetes reported anything even close.

Diabetes treated by surgery? Well, this is not a new concept. Actually, in 1992, an article was published under the provocatrive title: "Is type II diabetes mellitus (NIDDM) a surgical disease?". This is one reason why the professional organization for bariatric surgeons in North America changed its name from the "American Society for Bariatric Surgery" (ASBS) to the "American Society for Metabolic and Bariatric Surgery" (ASMBS)

The authors of the reference article, John B. Dixon, MBBS, PhD; Paul E. O’Brien, MD; Julie Playfair, RN; Leon Chapman, MBBS; Linda M. Schachter, MBBS, PhD; Stewart Skinner, MBBS, PhD are from the Centre for Obesity Research and Education (CORE), Monash University, Melbourne, Australia

References:

Dixon JB, O'Brien PE, Playfair J, Chapman L, Schachter LM, Skinner S, Proietto J, Bailey M, Anderson M. Adjustable Gastric Banding and Conventional Therapy for Type 2 Diabetes: A Randomized Controlled Trial. JAMA. 2008 Jan 23;299(3):316-323 (Abstract)

Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. PMID: 15479938 (Full Text)

Dixon JB, Pories WJ, O'Brien PE, Schauer PR, Zimmet P.Surgery as an effective early intervention for diabesity: why the reluctance? Diabetes Care. 2005 Feb;28(2):472-4. PMID: 15677819 (Full Text)

Pories WJ, MacDonald KG Jr, Flickinger EG, Dohm GL, Sinha MK, Barakat HA, May HJ, Khazanie P, Swanson MS, Morgan E, et al. Is type II diabetes mellitus (NIDDM) a surgical disease? Ann Surg. 1992 Jun;215(6):633-42; PMID: 1632685 (Full Text)

Video clip of animated bariatric procedures

A very good and easy-to-understand animation of the principles of the Roux-en-Y gastric bypass, the biliopancreatic diversion with duodenal switch procedure and the Lap Band, can be viewed in a video clip on the Mayo Clinic website.

http://www.mayoclinic.com/health/gastric-bypass/MM00703

LAP-BAND and REALIZE in USA

While world-wide, there is at least half a dozen of brands of adjustable gastric bands, the USA market had one brand, the Lap Band (manufactured by Inamed, a subsidiary of Allergan, Santa Barbara, California). (see "Adjustable Gastric Band" in the Glossary)

On Sept. 28, 2007, Ethicon Endo-Surgery, Inc. , Cincinnati, Ohio (an operating company of Johnson & Johnson) announced that the U.S. Food and Drug Administration (FDA) has approved for marketing the REALIZE(TM) Adjustable Gastric Band.

In the multi-center U.S. clinical trial of 276 patients with the REALIZE Band, patients who completed the three-year U.S. clinical trial (n=228) lost an average of 42.8 percent of their excess body weight. Thirty-five percent of patients who completed the three-year trial lost 50
percent or more of excess body weight and 10.5 percent lost 75 percent or more of excess body weight. The most commonly reported adverse events after surgery during the U.S. clinical trial were nausea, vomiting, constipation and gastroesophageal reflux (GERD). According to the report, nine (3.3 percent) patients experienced a serious adverse event that was considered unanticipated and related to the REALIZE Band.

According to the press release, the REALIZE Band, which is marketed under the name "Swedish Adjustable Gastric Band" (SAGB) outside the U.S., has been commercially available outside the U.S. since 1996 and has been used by more than 100,000 patients worldwide.

Source:
http://www.ethiconendo.com/.
http://www.realizeband.com/.