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


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.

SUBMITTER: Courcoulas AP 

PROVIDER: S-EPMC4905566 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

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Publications

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

Courcoulas Anita P AP   Belle Steven H SH   Neiberg Rebecca H RH   Pierson Sheila K SK   Eagleton Jessie K JK   Kalarchian Melissa A MA   DeLany James P JP   Lang Wei W   Jakicic John M JM  

JAMA surgery 20151001 10


<h4>Importance</h4>Questions remain about the role and durability of bariatric surgery for type 2 diabetes mellitus (T2DM).<h4>Objective</h4>To compare the remission of T2DM following surgical and nonsurgical treatments.<h4>Design, setting, and participants</h4>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  ...[more]

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