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.
RCT Entities:
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.
Authors: Thomas A Wadden; Delia Smith West; Linda Delahanty; John Jakicic; Jack Rejeski; Don Williamson; Robert I Berkowitz; David E Kelley; Christine Tomchee; James O Hill; Shiriki Kumanyika Journal: Obesity (Silver Spring) Date: 2006-05 Impact factor: 5.002
Authors: William C Knowler; Elizabeth Barrett-Connor; Sarah E Fowler; Richard F Hamman; John M Lachin; Elizabeth A Walker; David M Nathan Journal: N Engl J Med Date: 2002-02-07 Impact factor: 91.245
Authors: W H Polonsky; B J Anderson; P A Lohrer; G Welch; A M Jacobson; J E Aponte; C E Schwartz Journal: Diabetes Care Date: 1995-06 Impact factor: 19.112
Authors: Xavier Pi-Sunyer; George Blackburn; Frederick L Brancati; George A Bray; Renee Bright; Jeanne M Clark; Jeffrey M Curtis; Mark A Espeland; John P Foreyt; Kathryn Graves; Steven M Haffner; Barbara Harrison; James O Hill; Edward S Horton; John Jakicic; Robert W Jeffery; Karen C Johnson; Steven Kahn; David E Kelley; Abbas E Kitabchi; William C Knowler; Cora E Lewis; Barbara J Maschak-Carey; Brenda Montgomery; David M Nathan; Jennifer Patricio; Anne Peters; J Bruce Redmon; Rebecca S Reeves; Donna H Ryan; Monika Safford; Brent Van Dorsten; Thomas A Wadden; Lynne Wagenknecht; Jacqueline Wesche-Thobaben; Rena R Wing; Susan Z Yanovski Journal: Diabetes Care Date: 2007-03-15 Impact factor: 19.112
Authors: Philip R Schauer; Deepak L Bhatt; John P Kirwan; Kathy Wolski; Ali Aminian; Stacy A Brethauer; Sankar D Navaneethan; Rishi P Singh; Claire E Pothier; Steven E Nissen; Sangeeta R Kashyap Journal: N Engl J Med Date: 2017-02-16 Impact factor: 91.245
Authors: Zhamak Khorgami; Saeed Shoar; Alan A Saber; C Anthony Howard; Goodarz Danaei; Guido M Sclabas Journal: Obes Surg Date: 2019-03 Impact factor: 4.129