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Metabolic effects of bariatric surgery in patients withmoderate obesity and type 2 diabetes: Analysis of arandomized control trial comparing surgery with intensivemedical 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 inp

trial comparing surgery with intensive

Abood B, Pothier CE, Brethauer S, Nisse

Abstract

Objective: The growing incidence of ob

challenging contemporary threats to pu

plications, including myocardial infarct

goal of medical treatment is to halt dise

cardiovascular risk factors.2,3 Despite i

severe type 2 diabetes actually achieve

tional studieshave suggested that bariat

factors in severely obese patientswith t

with intensivemedical therapy, particu

the weight in kilograms divided by the

unanswered questions remain regardin

This randomized, controlled, single-ce

Diabetes Efficiently (STAMPEDE) trial, w

bypass or sleeve gastrectomy) as a mea

* Department of Surgery, Apollo Hospital,fax: þ91 9811082425.

E-mail address: surgerytimes@gmail.com0976-0016/$ e see front matterhttp://dx.doi.org/10.1016/j.apme.2013.05.003

atientswithmoderateobesity and type2diabetes:Analysis of a randomized control

medical treatment. Kashyap SR, Bhatt DL, Wolski K, Watanabe RM, Abdul-Ghani M,

n S, Gupta M, Kirwan JP, Schauer PR. Diabetes Care. 2013 Feb 25 [Epub ahead of print].

esity and type 2 diabetes mellitus globally is widely recognized as one of the most

blic health.1 Uncontrolled diabetes leads to macrovascular and microvascular com-

ion, stroke, blindness, neuropathy, and renal failure in many patients. The current

ase progression by reducing hyperglycemia, hypertension, dyslipidemia, and other

mprovements in pharmacotherapy, fewer than 50% of patients with moderate-to-

and maintain therapeutic thresholds, particularly for glycemic control.4 Observa-

ricormetabolic surgerycan rapidly improveglycemiccontrol andcardiovascular risk

ype 2 diabetes.5e9 Few randomized, controlled trials have compared bariatric surgery

larly inmoderately obese patients (defined as those having a bodyemass index [BMI,

square of the height in meters] of 30e35) with type 2 diabetes.10 Accordingly, many

g the relative efficacy of bariatric surgery in patients with uncontrolled diabetes.

nter study, called the Surgical Treatment and Medications Potentially Eradicate

as designed to compare intensive medical therapy with surgical treatment (gastric

ns of improving glycemic control in obese patients with type 2 diabetes.

Room 1268, 2nd Floor, Gate No. 10, New Delhi, UP 110044, India. Tel.: þ91 11 29871368;

.

Research design and methods: A prospective, randomized, controlled trial of 60 subjects with uncontrolled type 2 diabetes

(HbA(1c) 9.7 � 1%) andmoderate obesity (BMI 36 � 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 � 1.2% for gastric

bypass, 7.1 � 0.8% for sleeve gastrectomy, and 8.4 � 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 (�16 vs. �10%; 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. Themean (�SD) age of the patients was 49� 8 years, and 66%werewomen. The average glycated hemoglobin level

was 9.2 � 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 (P¼ 0.008). Glycemic control improved in all three groups, with a

mean glycated hemoglobin level of 7.5 � 1.8% in the medical-therapy group, 6.4 � 0.9% in the gastric-bypass group

(P < 0.001), and 6.6 � 1.0% in the sleeve-gastrectomy group (P ¼ 0.003). Weight loss was greater in the gastric-bypass group

and sleeve-gastrectomy group (�29.4 � 9.0 kg and �25.1 � 8.5 kg, respectively) than in the medical-therapy group

(�5.4� 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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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; survivalmay 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.

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