title: Adjustable Gastric Band Surgery or Medical Management in Patients With Type 2 Diabetes: A Randomized Clinical Trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  This was designed as a prospective, randomized clinical trial.
  
  
  METHODS
  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).
  
  
  METHODS
  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.
authors.affiliation: Harvard 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.
authors.forename: Su-Ann
authors.initials: SA
authors.lastname: Ding
authors.affiliation: Harvard 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.
authors.forename: Donald C
authors.initials: DC
authors.lastname: Simonson
authors.affiliation: Harvard 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.
authors.forename: Marlene
authors.initials: M
authors.lastname: Wewalka
authors.affiliation: Harvard 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.
authors.forename: Florencia
authors.initials: F
authors.lastname: Halperin
authors.affiliation: Harvard 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.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Foster
authors.affiliation: Harvard 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.
authors.forename: Ann
authors.initials: A
authors.lastname: Goebel-Fabbri
authors.affiliation: Harvard 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.
authors.forename: Osama
authors.initials: O
authors.lastname: Hamdy
authors.affiliation: Harvard 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.
authors.forename: Kerri
authors.initials: K
authors.lastname: Clancy
authors.affiliation: Harvard 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.
authors.forename: David
authors.initials: D
authors.lastname: Lautz
authors.affiliation: Harvard 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.
authors.forename: Ashley
authors.initials: A
authors.lastname: Vernon
authors.affiliation: Harvard 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.
authors.forename: Allison B
authors.initials: AB
authors.lastname: Goldfine
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy* / Q000601:surgery*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D015391:Gastroplasty / Q000295:instrumentation; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000150:complications / Q000188:drug therapy* / Q000601:surgery*; D015431:Weight Loss; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents