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 |

Surgical vs Medical Treatments for Type 2 Diabetes Mellitus:  A Randomized Clinical Trial

Anita P. Courcoulas, MD, MPH1; Bret H. Goodpaster, PhD2,3; Jessie K Eagleton, MPH1; Steven H. Belle, PhD, MScHyg4,5; Melissa A. Kalarchian, PhD6,7; Wei Lang, PhD8; Frederico G. S. Toledo, MD2; John M. Jakicic, PhD9
[+] Author Affiliations
1Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
2Division of Endocrinology and Metabolism, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
3Sanford Burnham Medical Research Institute, Florida Hospital Translational Research Institute, Orlando
4Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania
5Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania
6Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
7School of Nursing, Duquesne University, Pittsburgh, Pennsylvania
8Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina
9Department of Health and Physical Activity, University of Pittsburgh, Pittsburgh, Pennsylvania
JAMA Surg. 2014;149(7):707-715. doi:10.1001/jamasurg.2014.467.
Text Size: A A A
Published online

Importance  Many questions remain unanswered about the role of bariatric surgery for people with type 2 diabetes mellitus (T2DM).

Objective  To determine feasibility of a randomized clinical trial (RCT) and compare initial outcomes of bariatric surgery and a structured weight loss program for treating T2DM in participants with grades I and II obesity.

Design, Setting, and Participants  A 12-month, 3-arm RCT at a single center including 69 participants aged 25 to 55 years with a body mass index (calculated as weight in kilograms divided by height in meters squared) of 30 to 40 and T2DM.

Interventions  Roux-en-Y gastric bypass (RYGB), laparoscopic adjustable gastric banding (LAGB), and an intensive lifestyle weight loss intervention (LWLI).

Main Outcomes and Measures  Primary outcomes in the intention-to-treat cohort were feasibility and effectiveness measured by weight loss and improvements in glycemic control.

Results  Of 667 potential participants who underwent screening, 69 (10.3%) were randomized. Among the randomized participants, 30 (43%) had grade I obesity, and 56 (81%) were women. Mean (SD) age was 47.3 (6.4) years and hemoglobin A1c level, 7.9% (2.0%). After randomization, 7 participants (10%) refused to undergo their allocated intervention (3 RYGB, 1 LAGB, and 3 LWLI), and 1 RYGB participant was excluded for current smoking. Twenty participants underwent RYGB; 21, LAGB; and 20, LWLI, with 12-month retention rates of 90%, 86%, and 70%, respectively. In the intention-to-treat cohort with multiple imputation for missing data, RYGB participants had the greatest mean weight loss from baseline (27.0%; 95% CI, 30.8-23.3) compared with LAGB (17.3%; 95% CI, 21.1-13.5) and LWLI (10.2%; 95% CI, 14.8-5.61) (P < .001). Partial and complete remission of T2DM were 50% and 17%, respectively, in the RYGB group and 27% and 23%, respectively, in the LAGB group (P < .001 and P = .047 between groups for partial and complete remission), with no remission in the LWLI group. Significant reductions in use of antidiabetics occurred in both surgical groups. No deaths were noted. The 3 serious adverse events included 1 ulcer treated medically in the RYGB group and 2 rehospitalizations for dehydration in the LAGB group.

Conclusions and Relevance  This study highlights several potential challenges to successful completion of a larger RCT for treatment of T2DM and obesity in patients with a body mass index of 30 to 40, including the difficulties associated with recruiting and randomizing patients to surgical vs nonsurgical interventions. Preliminary results show that RYGB was the most effective treatment, followed by LAGB for weight loss and T2DM outcomes at 1 year.

Trial Registration  clinicaltrials.gov Identifier: NCT01047735

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.
CONSORT Diagram of Screening, Randomization, and Follow-up of Study Participants

LAGB indicates laparoscopic adjustable gastric banding; LWLI, lifestyle weight loss intervention; and RYGB, Roux-en-Y gastric bypass.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 2.
Remission of Type 2 Diabetes Mellitus (T2DM) at 12 Months

Partial remission of T2DM indicates no use of antidiabetics, hemoglobin A1c (HbA1c) level of less than 6.5%, and fasting plasma glucose (FPG) level of 125 mg/dL or less; complete remission of T2DM, no use of antidiabetics, HbA1c level of less than 5.7%; and FPG level of 100 mg/dL or less. Missing data at follow-up were assumed to be no remission. LAGB indicates laparoscopic adjustable gastric banding; LWLI, lifestyle weight loss intervention; and RYGB, Roux-en-Y gastric bypass.

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();