Metabolic effects of bariatric surgery in patients with moderate obesity and type 2 diabetes: Analysis of a randomized control trial comparing surgery with intensive medical treatment

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2. Journal Scan
Metabolic effects of bariatric surgery in patients with
moderate obesity and type 2 diabetes: Analysis of a
randomized control trial comparing surgery with intensive
medical treatment
Arun Prasad*
Senior Consultant Surgeon, Minimal Access, GI, Thoracoscopic & Bariatric Surgery, Apollo Hospital, New Delhi, India
a r t i c l e i n f o
Article history:
Received 6 May 2013
Accepted 8 May 2013
Available online 2 June 2013
Metabolic effects of bariatric surgery in patients with moderate obesity and type 2 diabetes: Analysis of a randomized control
trial comparing surgery with intensive medical treatment. Kashyap SR, Bhatt DL, Wolski K, Watanabe RM, Abdul-Ghani M,
Abood B, Pothier CE, Brethauer S, Nissen S, Gupta M, Kirwan JP, Schauer PR. Diabetes Care. 2013 Feb 25 [Epub ahead of print].
Abstract
Objective: The growing incidence of obesity and type 2 diabetes mellitus globally is widely recognized as one of the most
challenging contemporary threats to public health.1
Uncontrolled diabetes leads to macrovascular and microvascular com-
plications, including myocardial infarction, stroke, blindness, neuropathy, and renal failure in many patients. The current
goal of medical treatment is to halt disease progression by reducing hyperglycemia, hypertension, dyslipidemia, and other
cardiovascular risk factors.2,3
Despite improvements in pharmacotherapy, fewer than 50% of patients with moderate-to-
severe type 2 diabetes actually achieve and maintain therapeutic thresholds, particularly for glycemic control.4
Observa-
tional studies have suggested that bariatric or metabolic surgery can rapidly improve glycemic control and cardiovascular risk
factors in severely obese patients with type 2 diabetes.5e9
Few randomized, controlled trials have compared bariatric surgery
with intensive medical therapy, particularly in moderately obese patients (defined as those having a bodyemass index [BMI,
the weight in kilograms divided by the square of the height in meters] of 30e35) with type 2 diabetes.10
Accordingly, many
unanswered questions remain regarding the relative efficacy of bariatric surgery in patients with uncontrolled diabetes.
This randomized, controlled, single-center study, called the Surgical Treatment and Medications Potentially Eradicate
Diabetes Efficiently (STAMPEDE) trial, was designed to compare intensive medical therapy with surgical treatment (gastric
bypass or sleeve gastrectomy) as a means of improving glycemic control in obese patients with type 2 diabetes.
* Department of Surgery, Apollo Hospital, Room 1268, 2nd Floor, Gate No. 10, New Delhi, UP 110044, India. Tel.: þ91 11 29871368;
fax: þ91 9811082425.
E-mail address: surgerytimes@gmail.com.
Available online at www.sciencedirect.com
journal homepage: www.elsevier.com/locate/apme
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0976-0016/$ e see front matter
http://dx.doi.org/10.1016/j.apme.2013.05.003

3. Comments by Dr Arun Prasad
Emerging data suggest that bariatric surgery results in substantial improvements in glycemia, blood pressure, and cholesterol;
weight loss is durable; survival may be improved; and surgical risks are low. Novel surgical approaches are under development. At
the same time, there have been substantial medical advances, and multiple pharmacologic agents are now available to treat
diabetes and manage cardiovascular risk; pharmacologic weight loss agents and multipronged lifestyle strategies with multi-
disciplinary care are showing promise.
Understanding the relative risks and benefits of different treatment approaches for individuals with type 2 diabetes, as well as the
health care and other costs of such treatments, on a societal level will be of utmost importance in the coming years. Lessons from
the study of the neurohormonal changes after bariatric surgery may inform not only the best surgical procedure but also lead to
development of novel medical therapies, gastrointestinal interventions, or combination approaches to offer optimal manage-
ment for the prevention or treatment of type 2 diabetes.
Research design and methods: A prospective, randomized, controlled trial of 60 subjects with uncontrolled type 2 diabetes
(HbA(1c) 9.7 Æ 1%) and moderate obesity (BMI 36 Æ 2 kg/m2
) randomized to IMT alone, IMT plus Roux-en-Y gastric bypass, or
IMT plus sleeve gastrectomy. Assessment of b-cell function (mixed meal tolerance testing) and body composition were
performed at baseline and 12 and 24 months.
Results: Glycemic control improved in all three groups at 24 months (N ¼ 54), with a mean HbA(1c) of 6.7 Æ 1.2% for gastric
bypass, 7.1 Æ 0.8% for sleeve gastrectomy, and 8.4 Æ 2.3% for IMT (P < 0.05 for each surgical group versus IMT). Reduction in
body fat was similar for both surgery groups, with greater absolute reduction in truncal fat in gastric bypass versus sleeve
gastrectomy (À16 vs. À10%; P ¼ 0.04). Insulin sensitivity increased significantly from baseline in gastric bypass (2.7-fold;
P ¼ 0.004) and did not change in sleeve gastrectomy or IMT. b-cell function (oral disposition index) increased 5.8-fold in
gastric bypass from baseline, was markedly greater than IMT (P ¼ 0.001), and was not different between sleeve gastrectomy
versus IMT (P ¼ 0.30). At 24 months, b-cell function inversely correlated with truncal fat and prandial free fatty acid levels.
Conclusions: Bariatric surgery provides durable glycemic control compared with intensive medical therapy at 2 years.
Despite similar weight loss as sleeve gastrectomy, gastric bypass uniquely restores pancreatic b-cell function and reduces
truncal fat, thus reversing the core defects in diabetes.
Bariatric surgery versus intensive medical therapy in obese patients with diabetes. Schauer Philip R, Kashyap Sangeeta R,
Wolski Kathy, Brethauer Stacy A, Kirwan John P, Pothier Claire E, Thomas Susan, Abood Beth, Nissen Steven E, Bhatt Deepak
L. N Engl J Med. 2012;366:1567e1576. http://dx.doi.org/10.1056/NEJMoa1200225.
Background: Observational studies have shown improvement in patients with type 2 diabetes mellitus after bariatric
surgery.
Methods: In this randomized, nonblinded, single-center trial, we evaluated the efficacy of intensive medical therapy alone
versus medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy in 150 obese patients with uncontrolled type 2
diabetes. The mean (ÆSD) age of the patients was 49 Æ 8 years, and 66% were women. The average glycated hemoglobin level
was 9.2 Æ 1.5%. The primary end point was the proportion of patients with a glycated hemoglobin level of 6.0% or less 12
months after treatment.
Results: Of the 150 patients, 93% completed 12 months of follow-up. The proportion of patients with the primary end point
was 12% (5 of 41 patients) in the medical-therapy group versus 42% (21 of 50 patients) in the gastric-bypass group (P ¼ 0.002)
and 37% (18 of 49 patients) in the sleeve-gastrectomy group (P ¼ 0.008). Glycemic control improved in all three groups, with a
mean glycated hemoglobin level of 7.5 Æ 1.8% in the medical-therapy group, 6.4 Æ 0.9% in the gastric-bypass group
(P < 0.001), and 6.6 Æ 1.0% in the sleeve-gastrectomy group (P ¼ 0.003). Weight loss was greater in the gastric-bypass group
and sleeve-gastrectomy group (À29.4 Æ 9.0 kg and À25.1 Æ 8.5 kg, respectively) than in the medical-therapy group
(À5.4 Æ 8.0 kg) (P < 0.001 for both comparisons). The use of drugs to lower glucose, lipid, and blood-pressure levels decreased
significantly after both surgical procedures but increased in patients receiving medical therapy only. The index for ho-
meostasis model assessment of insulin resistance (HOMA-IR) improved significantly after bariatric surgery. Four patients
underwent reoperation. There were no deaths or life-threatening complications.
Conclusions: In obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery
achieved glycemic control in significantly more patients than medical therapy alone. Further study will be necessary to
assess the durability of these results.
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