Adjustable Gastric Band Surgery or Medical Management in Patients With Type 2 Diabetes: A Randomized Clinical Trial

Abstract

Context: Recommendations for surgical, compared with lifestyle and pharmacologically based, approaches for type 2 diabetes (T2D) management remain controversial.

Objective: The objective was to compare laparoscopic adjustable gastric band (LAGB) to an intensive medical diabetes and weight management (IMWM) program for T2D.

Design: This was designed as a prospective, randomized clinical trial.

Setting: The setting was two Harvard Medical School-affiliated academic institutions. INTERVENTIONS AND PARTICIPANTS: A 12-month randomized trial comparing LAGB (n = 23) vs IMWM (n = 22) in persons aged 21-65 years with body mass index of 30-45 kg/m(2), T2D diagnosed more than 1 year earlier, and glycated hemoglobin (HbA(1c)) ≥ 6.5% on antihyperglycemic medication(s).

Main outcome measure: The proportion meeting the prespecified primary glycemic endpoint, defined as HbA(1c) < 6.5% and fasting glucose < 7.0 mmol/L at 12 months, on or off medication.

Results: After randomization, five participants did not undergo the surgical intervention. Of the 40 initiating intervention (22 males/18 females; age, 51 ± 10 y; body mass index, 36.5 ± 3.7 kg/m(2); diabetes duration, 9 ± 5 y; HbA(1c), 8.2 ± 1.2%; 40% on insulin), the proportion meeting the primary glycemic endpoint was achieved in 33% of the LAGB patients and 23% of the IMWM patients (P = .457). HbA(1c) reduction was similar between groups at both 3 and 12 months (-1.2 ± 0.3 vs -1.0 ± 0.3%; P = .496). Weight loss was similar at 3 months but greater 12 months after LAGB (-13.5 ± 1.7 vs -8.5 ± 1.6 kg; P = .027). Systolic blood pressure reduction was greater after IMWM than LAGB, whereas changes in diastolic blood pressure, lipids, fitness, and cardiovascular risk scores were similar between groups. Patient-reported health status, assessed using the Short Form-36, Impact of Weight on Quality of Life, and Problem Areas in Diabetes, all improved similarly between groups.

Conclusions: LAGB and a multidisciplinary IMWM program have similar 1-year benefits on diabetes control, cardiometabolic risk, and patient satisfaction, which should be considered in the context of other factors, such as personal preference, when selecting treatment options with obese T2D patients. Longer duration studies are important to understand emergent differences.

Trial registration: ClinicalTrials.gov NCT01073020.

Figures

Figure 1.

Enrollment, randomization, and retention of the study participants. A1c, glycated hemoglobin; n, number; PMH, past medical history.

Figure 2.

A–C, Glycemic measures of changes in HbA1c (A), fasting blood glucose (B), and BMI (C) are graphed by treatment group and time as baseline adjusted means with SE. P Values are for the difference between groups in linear mixed model adjusted for baseline. D, Mean number of diabetes medications is shown by treatment group and time. E, Changes from baseline for UKPDS risk scores are shown with SE for coronary heart disease (CHD), fatal CHD, stroke, and fatal stroke. Variance shown is SE. Black bars, LAGB; gray bars, IMWM. F, The relationship between total weight lost and change in fat by bioelectrical impedance is shown. ●, LAGB; ○, IMWM. WL, weight loss.

Figure 3.

Patient-reported outcomes are shown for SF-36 including total score, PH, and MH subscores (A); PAID (B); Barriers to Being Active (C); EQ-5D (trademark of the EuroQol Group) index scale (D); and IWQOL-lite (E). Data are graphed by treatment group and time as baseline adjusted mean change from baseline and SE. Dark gray columns, LAGB; light gray columns, IMWM. Baseline mean and SD of all patient-reported outcomes are provided in Supplemental Table 3. Comparisons between groups were not statistically significant overall, or at early or 12-month assessment. F, The relationship between change in HbA1c and change in PAID scores is shown. ●, LAGB; ○, IMWM. a, P < .01; b, P < .001; and c, P < .05 (within group change from baseline, not between group differences).