Patient-reported outcomes 1 year after randomization to laparoscopic adjustable gastric banding or intensive weight and diabetes management in obese patients with type 2 diabetes mellitus

The Endocrine Society's 97th Annual Meeting & Expo (ENDO 2015)DC Simonson, SA Ding, F Halperin, M Wewalka, K Foster, K Kelly, J Panosian, A Goebel-Fabbri, O Hamdy, K Clancy, D Lautz, A Vernon, AB Goldfine | March 05, 2015

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Summary: Laparoscopic adjustable gastric band (LAGB) and intensive medical diabetes and weight management program (IMWM) both result in significant weight loss and reduction in HbA1c in patients with type 2 diabetes (T2D), researchers concluded. They also found that although weight loss is greater after LAGB, improvements in HbA1c are similar. Finally, both treatments were found to be associated with small but comparable changes in self-reported physical and mental health status as measured by the SF-36, and both treatments were associated with significant reductions in the impact of weight on quality of life (QOL) and problem areas in diabetes, with no differences between groups.

Methods:

  • Researchers randomized 40 obese patients with T2D (22M/18F; weight: 109±15 kg; BMI: 36.5±3.7 kg/m²; age: 51±10 yrs; diabetes duration: 9±5 yrs; HbA1c 8.2±1.2%; 40% on insulin) to LAGB (n=18) or a 12-week IMWM (n=22) with follow-up for 12 months.

Results:

  • Both groups had comparable baseline SF-36 physical health (PH) (76±14) and mental health (MH) (75±13) status scores, and moderately elevated Impact of Weight on Quality of Life (IWQOL) (59±17) and Problem Areas in Diabetes (PAID) (46±14) scores. 
  • After 10% weight loss or 3 months if 10% loss was not achieved, LAGB and IWMW achieved similarly significant weight loss (-9.7±0.8 vs -9.2±0.8 kg) and improvement in HbA1c (-1.0±0.3 vs -1.7±0.3%; P=0.06 between groups), respectively. 
  • Researchers observed that from baseline, SF-36 PH (2±2 vs 6±1) and MH (2±2 vs 6±2) improved minimally in LAGB and IMWM, with no differences between groups, as did IWQOL (-11 ± 2 vs. -9 ± 2) and PAID (-7±2 vs. -9±2) (PP<0.01), but improvements were similar in both groups. 
  • At 12 months, weight loss was significantly greater after LAGB (-13.5±1.7 vs -8.5±1.6 kg; P<0.05), but there was no difference in lowering of HbA1c (-1.2±0.3 vs -1.0±0.3%). 
  • Compared with the earlier assessment, SF-36 PH and MH changed minimally, with no differences between groups. 
  • Changes in IWQOL (-14±2 vs -11±2) and PAID (-13±2 vs -13±2) further improved significantly from baseline in both LAGB and IMWM, respectively (P
  • Finally, researchers found that, in both groups combined, HbA1c improvement correlated with the improvement in patient’s self-assessment of diabetes-specific emotional distress, as assessed by PAID (r=0.51, P<0.01).

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