End-of-Trial Health Outcomes in Look AHEAD Participants who Elected to have Bariatric Surgery

Abstract

Objective: This study examined end-of-trial health outcomes in participants in the Action for Health in Diabetes (Look AHEAD) trial who had bariatric surgery during the approximately 10-year randomized intervention.

Methods: Data were obtained from the Look AHEAD public access database of 4,901 individuals with type 2 diabetes and overweight/obesity who were assigned to intensive lifestyle intervention (ILI) or a diabetes support and education (DSE) control group. Changes in outcomes in participants who had bariatric surgery were compared with those in participants with BMI ≥ 30 kg/m2 who remained in the ILI and DSE groups.

Results: A total of 99 DSE and 97 ILI participants had bariatric surgery. At randomization, these 196 participants were significantly younger and more likely to be female and to have higher BMI than the remaining ILI (N = 1,972) and DSE (N = 2,009) participants. At trial's end, surgically treated participants lost 19.3% of baseline weight, compared with 5.8% and 3.3% for the ILI and DSE groups, respectively, and were more likely to achieve partial or full remission of their diabetes.

Conclusions: The large, sustained improvements in weight and diabetes observed in this self-selected sample of surgically treated participants are consistent with results of multiple randomized trials.

Trial registration: ClinicalTrials.gov NCT00017953.

Conflict of interest statement

Dr. Jakicic reports serving on a scientific advisory board for Weight Watchers, and Dr. Wadden serves on scientific advisory boards for Novo Nordisk and Weight Watchers. The other authors report no conflicts of interest.

© 2019 The Obesity Society.

Figures

Figure 1:

The figure shows the flow of participants through the approximately 10-year Look AHEAD randomized trial. The 4,177 participants are from a total of 4,901 represented in the Look AHEAD public access data set. All 4,177 participants were selected to have a baseline body mass index (BMI) ≥ 30 kg/m2, with the exception of two patients with BMIs of 27.9 and 29.9 kg/m2 who had bariatric surgery (and were included in the analyses). End of trial was assessed at year 8 or beyond, depending on when participants entered the study.

Figure 2:

Cumulative incidence of bariatric surgery in the diabetes support and education (DSE) and intensive lifestyle interventions (ILI) groups.

Figure 3:

The figure shows the mean percentage change in baseline weight from years 1 to 9 for participants assigned to the diabetes support and education (DSE) and intensive lifestyle intervention (ILI) groups. For DSE and ILI participants who elected to have bariatric surgery, the figure shows the number who did so each year and their weight change (as assessed from baseline) at the last annual assessment before surgery, as compared to the mean weight change at the same time for DSE and ILI participants who did not have surgery. Year 0 shows that 9 DSE and 5 ILI participants who had surgery in the first year of the trial. A total of 18 surgery participants did not provide a measured weight at the annual assessment that preceded their having surgery. Three participants had LAGB and later went on to have RYGB. Their weights are only included for their first surgery, LAGB.

Figure 4:

Percent reduction in initial weight at the end of trial for participants assigned to the intensive lifestyle intervention (ILI) and diabetes support and education (DSE) groups, as well as those who underwent Roux-en-Y gastric bypass (RYGB, N=127), sleeve gastrectomy (SG, N=11) or laparoscopic adjustable banding (LAGB, N=58). Three participants had LAGB and later went on to have RYGB. Their end-of-trial weights are counted in the RYGB category.

Figure 5:

Percentage of participants who achieved end-of-trial remission of type 2 diabetes (partial or full), according to assignment to the intensive lifestyle intervention (ILI) or diabetes support and education (DSE) groups, as well as participants who had bariatric surgery.