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JAMA Surg. 2015 Oct;150(10):931-40. doi: 10.1001/jamasurg.2015.1534.

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

Author information

1
Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
2
Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania3Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania.
3
Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, South Carolina.
4
School of Nursing, Duquesne University, Pittsburgh, Pennsylvania.
5
Division of Endocrinology and Metabolism, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.
6
Physical Activity and Weight Management Research Center, Department of Health and Physical Activity, University of Pittsburgh, Pittsburgh, Pennsylvania.

Abstract

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.

PMID:
26132586
PMCID:
PMC4905566
DOI:
10.1001/jamasurg.2015.1534
[Indexed for MEDLINE]
Free PMC Article

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