0
We're unable to sign you in at this time. Please try again in a few minutes.
Retry
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
Retry
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Original Investigation |

Roux-en-Y Gastric Bypass Surgery or Lifestyle With Intensive Medical Management in Patients With Type 2 Diabetes:  Feasibility and 1-Year Results of a Randomized Clinical Trial

Florencia Halperin, MD1; Su-Ann Ding, MD2; Donald C. Simonson, MD, MPH, ScD1; Jennifer Panosian, BA2; Ann Goebel-Fabbri, PhD2; Marlene Wewalka, MD2; Osama Hamdy, MD, PhD2; Martin Abrahamson, MD2; Kerri Clancy, RN3; Kathleen Foster, RN2; David Lautz, MD3; Ashley Vernon, MD3; Allison B. Goldfine, MD2
[+] Author Affiliations
1Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
2Research Division, Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts
3Center for Metabolic and Bariatric Surgery, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
JAMA Surg. 2014;149(7):716-726. doi:10.1001/jamasurg.2014.514.
Text Size: A A A
Published online

Importance  Emerging data support bariatric surgery as a therapeutic strategy for management of type 2 diabetes mellitus.

Objective  To test the feasibility of methods to conduct a larger multisite trial to determine the long-term effect of Roux-en-Y gastric bypass (RYGB) surgery compared with an intensive diabetes medical and weight management (Weight Achievement and Intensive Treatment [Why WAIT]) program for type 2 diabetes.

Design, Setting, and Participants  A 1-year pragmatic randomized clinical trial was conducted in an academic medical institution. Participants included persons aged 21 to 65 years with type 2 diabetes diagnosed more than 1 year before the study; their body mass index was 30 to 42 (calculated as weight in kilograms divided by height in meters squared) and hemoglobin A1c (HbA1c) was greater than or equal to 6.5%. All participants were receiving antihyperglycemic medications.

Interventions  RYGB (n = 19) or Why WAIT (n = 19) including 12 weekly multidisciplinary group lifestyle, medical, and educational sessions with monthly follow-up thereafter.

Main Outcomes and Measures  Proportion of patients with fasting plasma glucose levels less than 126 mg/dL and HbA1c less than 6.5%, measures of cardiometabolic health, and patient-reported outcomes.

Results  At 1 year, the proportion of patients achieving HbA1c below 6.5% and fasting glucose below 126 mg/dL was higher following RYGB than Why WAIT (58% vs 16%, respectively; P = .03). Other outcomes, including HbA1c, weight, waist circumference, fat mass, lean mass, blood pressure, and triglyceride levels, decreased and high-density lipoprotein cholesterol increased more after RYGB compared with Why WAIT. Improvement in cardiovascular risk scores was greater in the surgical group. At baseline the participants exhibited moderately low self-reported quality-of-life scores reflected by Short Form-36 total, physical health, and mental health, as well as high Impact of Weight on Quality of Life–Lite and Problem Areas in Diabetes health status scores. At 1 year, improvements in Short Form-36 physical and mental health scores and Problem Areas in Diabetes scores did not differ significantly between groups. The Impact of Weight on Quality of Life–Lite score improved more with RYGB and correlated with greater weight loss compared with Why WAIT.

Conclusions and Relevance  In obese patients with type 2 diabetes, RYGB produces greater weight loss and sustained improvements in HbA1c and cardiometabolic risk factors compared with medical management, with emergent differences over 1 year. Both treatments improve general quality-of-life measures, but RYGB provides greater improvement in the effect of weight on quality of life. These differences may help inform therapeutic decisions for diabetes and weight loss strategies in obese patients with type 2 diabetes until larger randomized trials are performed.

Trial Registration  clinicaltrials.gov Identifier: NCT01073020

Figures in this Article

Sign in

Create a free personal account to sign up for alerts, share articles, and more.

Purchase Options

• Buy this article
• Subscribe to the journal

First Page Preview

View Large
First page PDF preview

Figures

Place holder to copy figure label and caption
Figure 1.
Enrollment, Randomization, and Retention of the Study Participants

BMI indicates body mass index; GAD, antiglutamic acid decarboxylase antibody–positive; HbA1c, hemoglobin A1c; LAGB, laparoscopic adjustable gastric band; RYGB, Roux-en-Y gastric bypass; and WAIT, Weight Achievement and Intensive Treatment.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 2.
Changes in Cardiometabolic Outcomes Following Bariatric Surgery and Medical Management

Changes in hemoglobin A1c (HbA1c) (A), fasting plasma glucose (B), and body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) (C) graphed by treatment group and time as baseline-adjusted mean, with SE indicated with limit lines. P values indicate the significant difference between groups in linear mixed model adjusted for baseline. Mean number of diabetes medications (D). Change from baseline for United Kingdom Prospective Diabetes Study (UKPDS) Risk Scores for coronary heart disease (CHD), fatal CHD, stroke, and fatal stroke. Variance indicated with the limit lines is SE (E). The relationship between total weight lost (WL) and change in fat by bioelectrical impedance (F). RYGB indicates Roux-en-Y gastric bypass; WAIT, Weight Achievement and Intensive Treatment.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 3.
Patient-Reported Outcomes and Change in Body Mass Index (BMI) and Impact of Weight on Quality of Life–Lite (IWQOL)

A, Short-Form 36 (SF-36). B, Problem Areas in Diabetes (PAID). C, Barriers to Being Active. D, EuroQol 5 Dimensions (EQ-5D) visual analog scale (VAS). E, IWQOL. F, Relationship between change in BMI and change in IWQOL scores. Data are graphed by treatment group and time as baseline-adjusted mean change from baseline and SE, indicated with limit lines. Baseline mean (SD) of all patient-reported outcomes are provided in the Supplement (eTable 6). RYGB indicates Roux-en-Y gastric bypass; WAIT, Weight Achievement and Intensive Treatment; and WL, weight loss.aP < .001 (within-group comparison).bP < .01 (between-group comparison).cP < .001 (between-group comparison).dP < .01 (within-group comparison).eP < .05 (between-group comparison).

Graphic Jump Location

Tables

References

Correspondence

CME
Also Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Please click the checkbox indicating that you have read the full article in order to submit your answers.
Your answers have been saved for later.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.
Submit a Comment

Multimedia

Some tools below are only available to our subscribers or users with an online account.

Web of Science® Times Cited: 2

Sign in

Create a free personal account to sign up for alerts, share articles, and more.

Purchase Options

• Buy this article
• Subscribe to the journal

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Collections
PubMed Articles
Jobs
JAMAevidence.com

Users' Guides to the Medical Literature
Clinical Resolution

Users' Guides to the Medical Literature
Clinical Scenario

brightcove.createExperiences();