Adjustable Gastric Band Surgery or Medical Management in Patients With Type 2 Diabetes: A Randomized Clinical Trial. Ding SA, Simonson DC, Wewalka M, Halperin F, Foster K, Goebel-Fabbri A, Hamdy O, Clancy K, Lautz D, Vernon A, Goldfine AB. J Clin Endocrinol Metab. 2015 Jul;100(7):2546-56. doi: 10.1210/jc.2015-1443. Epub 2015 Apr 24.
The objective was to compare laparoscopic adjustable gastric band (LAGB) to an intensive
medical diabetes and weight management (IMWM) program for T2D. Read about these findings by going to https://www.ncbi.nlm.nih.gov/pubmed/25909333
Adjustable Gastric Band Surgery or Medical Management in Patients With Type 2 Diabetes: A Randomized Clinical Trial.
Author information
- 1Harvard Medical School (S.D., D.C.S., M.W., F.H., A.G.-F., O.H., D.L., A.V., A.B.G.), Boston, Massachusetts 02115; Joslin Diabetes Center (S.D., M.W., F.H., K.F., A.G.-F., O.H., A.B.G.), Boston, Massachusetts 02215; and Brigham and Women’s Hospital (D.C.S., F.H., K.C., D.L., A.V., A.B.G.), Boston, Massachusetts 02115.
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.
Comment in
- Surgical Treatment of Diabetes: Making a Case for a Pragmatic Approach. [J Clin Endocrinol Metab. 2015]
- PMID:
- 25909333
- [PubMed – indexed for MEDLINE]
- PMCID:
- PMC4490302
- [Available on 2016-07-01]
