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Original Investigation |

Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment A Randomized Clinical Trial

Anita P. Courcoulas, MD, MPH1; Steven H. Belle, PhD, MScHyg2,3; Rebecca H. Neiberg, MS4; Sheila K. Pierson, BS, BA1; Jessie K Eagleton, MPH1; Melissa A. Kalarchian, PhD5; James P. DeLany, PhD6; Wei Lang, PhD4; John M. Jakicic, PhD7
[+] Author Affiliations
1Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
2Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania
3Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania
4Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, South Carolina
5School of Nursing, Duquesne University, Pittsburgh, Pennsylvania
6Division of Endocrinology and Metabolism, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
7Physical Activity and Weight Management Research Center, Department of Health and Physical Activity, University of Pittsburgh, Pittsburgh, Pennsylvania
JAMA Surg. 2015;150(10):931-940. doi:10.1001/jamasurg.2015.1534.
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Importance  Questions remain about the role and durability of bariatric surgery for type 2 diabetes mellitus (T2DM).

Objective  To compare the remission of T2DM following surgical and nonsurgical treatments.

Design, Setting, and Participants  In this 3-arm randomized clinical trial conducted at the University of Pittsburgh Medical Center from October 1, 2009, to June 26, 2014, in Pittsburgh, Pennsylvania, outcomes were assessed 3 years after treating 61 obese participants aged 25 to 55 years with T2DM. Analysis was conducted with an intent-to-treat population.

Interventions  Participants were randomized to either an intensive lifestyle weight loss intervention for 1 year followed by a low-level lifestyle intervention for 2 years or surgical treatments (Roux-en-Y gastric bypass [RYGB] or laparoscopic adjustable gastric banding [LAGB]) followed by low-level lifestyle intervention in years 2 and 3.

Main Outcomes and Measures  Primary end points were partial and complete T2DM remission and secondary end points included diabetes medications and weight change.

Results  Body mass index (calculated as weight in kilograms divided by height in meters squared) was less than 35 for 26 participants (43%), 50 (82%) were women, and 13 (21%) were African American. Mean (SD) values were 100.5 (13.7) kg for weight, 47.3 (6.6) years for age, 7.8% (1.9%) for hemoglobin A1c level, and 171.3 (72.5) mg/dL for fasting plasma glucose level. Partial or complete T2DM remission was achieved by 40% (n = 8) of RYGB, 29% (n = 6) of LAGB, and no intensive lifestyle weight loss intervention participants (P = .004). The use of diabetes medications was reduced more in the surgical groups than the lifestyle intervention–alone group, with 65% of RYGB, 33% of LAGB, and none of the intensive lifestyle weight loss intervention participants going from using insulin or oral medication at baseline to no medication at year 3 (P < .001). Mean (SE) reductions in percentage of body weight at 3 years were the greatest after RYGB at 25.0% (2.0%), followed by LAGB at 15.0% (2.0%) and lifestyle treatment at 5.7% (2.4%) (P < .01).

Conclusions and Relevance  Among obese participants with T2DM, bariatric surgery with 2 years of an adjunctive low-level lifestyle intervention resulted in more disease remission than did lifestyle intervention alone.

Trial Registration  clinicaltrials.gov Identifier: NCT01047735

Figures in this Article

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Figure 1.
Study Flowchart
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Figure 2.
Prevalence of Any Remission (Partial or Complete) by Treatment Group and Year

Partial remission of type 2 diabetes mellitus included no use of antidiabetics, hemoglobin A1c level of less than 6.5% (to convert to proportion of total hemoglobin, multiply by 0.01), and fasting plasma glucose level of 125 mg/dL or less (to convert to millimoles per liter, multiply by 0.0555). Complete remission of type 2 diabetes mellitus included no use of antidiabetics, hemoglobin A1c level of less than 5.7%, and fasting plasma glucose level of 100 mg/dL or less. Missing data at follow-up were assumed to be no remission. The test of the difference between treatment group P values are calculated for each point as follows: year 1, P < .001; year 2, P < .001; and year 3, P = .004. LAGB indicates laparoscopic adjustable gastric banding; LWLI, lifestyle weight loss intervention (intensive); and RYGB, Roux-en-Y gastric bypass.

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Figure 3.
Hemoglobin A1c (HbA1c) (A) and Fasting Plasma Glucose (FPG) (B) Level Changes by Treatment Group and Year

LAGB indicates laparoscopic adjustable gastric banding; LWLI, lifestyle weight loss intervention (intensive); and RYGB, Roux-en-Y gastric bypass. The bars indicate standard errors. To convert FPG to millimoles per liter, multiply by 0.0555; and HbA1c to proportion of total hemoglobin, multiply by 0.01.

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Figure 4.
Diabetes Medication Use by Treatment Group

A, Baseline, n = 20; year 1, n=18; year 2, n = 18; and year 3, n = 18. B, Baseline, n = 21; year 1, n = 19; year 2, n = 17; and year 3, n = 20. C, Baseline, n = 20; year 1, n = 14; year 2, n = 14; and year 3, n = 14 (1 participant was missing data). LAGB indicates laparoscopic adjustable gastric banding; LWLI, lifestyle weight loss intervention (intensive); and RYGB, Roux-en-Y gastric bypass.

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Figure 5.
Percentage of Weight Change From Baseline by Treatment Group

Modeled data and the bars indicate standard errors. LAGB indicates laparoscopic adjustable gastric banding; LWLI, lifestyle weight loss intervention (intensive); and RYGB, Roux-en-Y gastric bypass.

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