Improvements in Diabetes Control Similar in Patients Who Undergo LAGB or Intensive Management

Summary

Laparoscopic gastric banding and an intensive nonsurgical intervention appear to provide similar outcomes among patients who are obese with type 2 diabetes mellitus. At 1 year, patients who underwent gastric banding lost more weight than those who had no surgery, but no significant differences were seen in HbA1c, fasting blood sugar, or other cardiometabolic measures.

  • gastric banding
  • lifestyle intervention
  • HbA1c
  • obesity
  • type 2 diabetes mellitus
  • NCT01073020
  • endocrinology, diabetes & metabolism clinical trials
  • cardiometabolic disorder

Because of advances in both the surgical and nonsurgical treatment of obesity in adults with type 2 diabetes mellitus (T2DM), there is increasing controversy regarding the best treatment algorithm for patients who are obese with T2DM.

The SLIMM-T2D study [NCT01073020] was a 1-year pragmatic randomized trial within a single hospital setting. The trial was designed to compare clinical outcomes between patients who are obese with T2DM who underwent laparoscopic adjustable gastric band surgery (LAGB) or Roux-en-Y gastric bypass (RYGB) and those who participated in Why WAIT, a nonsurgical intensive diabetes and weight loss intervention. Why WAIT incorporated intensive diet, exercise, education, and drug modification using a multidisciplinary approach that included a dietitian, a psychologist, a diabetes educator, an exercise physiologist, and a physician who prescribed medications considered weight neutral. Patients in the Why WAIT intervention received 2 hours of instruction per week and individualized exercise training for the first 12 weeks, with monthly one-on-one support visits for the remainder of the 1-year follow-up.

The primary end point was the number of patients with fasting blood sugar < 126 mg/dL and HbA1c < 6.5% at 1 year. Secondary end points included measurement of metabolic and cardiovascular risk factors.

Data from the RYGB arm of the trial were previously published [Halperin F et al. JAMA Surg. 2014] and showed that, compared with medical management, RYGB produced sustained and statistically significant improvements in HbA1c and fasting glucose (P = .03), as well as greater weight loss and reduction in cardiometabolic risk factors at 1 year.

Donald C. Simonson, MD, MPH, ScD, Brigham and Women’s Hospital, Boston, Massachusetts, USA, presented data from the LAGB arm of SLIMM-T2D. Forty patients were randomized to either LAGB (n = 18; 9 men, 9 women) or medical management (n = 22; 13 men, 9 women), with 12 months of follow-up. Other baseline characteristics are outlined in Table 1.

Table 1.

Baseline Patient Characteristics

At 12 months, there was no significant difference between the 2 groups in the primary end point of HbA1c < 6.5% and fasting blood sugar < 126 mg/dL (P = .46). There was also no significant difference in the number of patients who met all 3 treatment goals prescribed by the American Diabetes Association (HbA1c < 7.0%, low-density lipoprotein < 100 mg/dL, systolic blood pressure < 130 mm Hg; P = .77). However, patients in the LAGB group lost significantly more weight than their Why WAIT counterparts (–13.5 ± 1.7 kg vs −8.5 ± 1.6 kg; P < 0.05).

In conclusion, among patients who are obese with T2DM, weight loss was significantly greater in the LAGB group. There were no significant differences in biochemical measures associated with either LAGB or an intensive weight and exercise management program. Programs similar to Why WAIT may be a plausible option for patients who are not good candidates for LAGB or who choose not to undergo the procedure.

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