Surgical vs Medical Treatments for Type 2 Diabetes Mellitus A Randomized Clinical Trial

被引:165
作者
Courcoulas, Anita P. [1 ]
Goodpaster, Bret H. [2 ,3 ]
Eagleton, Jessie K. [1 ]
Belle, Steven H. [4 ,5 ]
Kalarchian, Melissa A. [6 ,7 ]
Lang, Wei [8 ]
Toledo, Frederico G. S. [2 ]
Jakicic, John M. [9 ]
机构
[1] Univ Pittsburgh, Med Ctr, Dept Surg, Pittsburgh, PA 15213 USA
[2] Univ Pittsburgh, Dept Med, Div Endocrinol & Metab, Pittsburgh, PA 15213 USA
[3] Florida Hosp, Translat Res Inst, Sanford Burnham Med Res Inst, Orlando, FL USA
[4] Univ Pittsburgh, Grad Sch Publ Hlth, Dept Epidemiol, Pittsburgh, PA 15213 USA
[5] Univ Pittsburgh, Grad Sch Publ Hlth, Dept Biostat, Pittsburgh, PA 15213 USA
[6] Univ Pittsburgh, Sch Med, Dept Psychiat, Pittsburgh, PA 15213 USA
[7] Duquesne Univ, Sch Nursing, Pittsburgh, PA 15219 USA
[8] Wake Forest Sch Med, Dept Biostat Sci, Winston Salem, NC USA
[9] Univ Pittsburgh, Dept Hlth & Phys Act, Pittsburgh, PA 15213 USA
基金
美国国家卫生研究院;
关键词
LIFE-STYLE INTERVENTION; Y GASTRIC BYPASS; BARIATRIC SURGERY; THERAPY; WEIGHT;
D O I
10.1001/jamasurg.2014.467
中图分类号
R61 [外科手术学];
学科分类号
摘要
IMPORTANCE Many questions remain unanswered about the role of bariatric surgery for people with type 2 diabetes mellitus (T2DM). OBJECTIVE To determine feasibility of a randomized clinical trial (RCT) and compare initial outcomes of bariatric surgery and a structured weight loss program for treating T2DM in participants with grades I and II obesity. DESIGN, SETTING, AND PARTICIPANTS A 12-month, 3-arm RCT at a single center including 69 participants aged 25 to 55 years with a body mass index (calculated as weight in kilograms divided by height in meters squared) of 30 to 40 and T2DM. INTERVENTIONS Roux-en-Y gastric bypass (RYGB), laparoscopic adjustable gastric banding (LAGB), and an intensive lifestyle weight loss intervention (LWLI). MAIN OUTCOMES AND MEASURES Primary outcomes in the intention-to-treat cohort were feasibility and effectiveness measured by weight loss and improvements in glycemic control. RESULTS Of 667 potential participants who underwent screening, 69 (10.3%) were randomized. Among the randomized participants, 30 (43%) had grade I obesity, and 56 (81%) were women. Mean (SD) age was 47.3 (6.4) years and hemoglobin A(1c) level, 7.9% (2.0%). After randomization, 7 participants (10%) refused to undergo their allocated intervention (3 RYGB, 1 LAGB, and 3 LWLI), and 1 RYGB participant was excluded for current smoking. Twenty participants underwent RYGB; 21, LAGB; and 20, LWLI, with 12-month retention rates of 90%, 86%, and 70%, respectively. In the intention-to-treat cohort with multiple imputation for missing data, RYGB participants had the greatest mean weight loss from baseline (27.0%; 95% CI, 30.8-23.3) compared with LAGB (17.3%; 95% CI, 21.1-13.5) and LWLI (10.2%; 95% CI, 14.8-5.61) (P < .001). Partial and complete remission of T2DM were 50% and 17%, respectively, in the RYGB group and 27% and 23%, respectively, in the LAGB group (P < .001 and P = .047 between groups for partial and complete remission), with no remission in the LWLI group. Significant reductions in use of antidiabetics occurred in both surgical groups. No deaths were noted. The 3 serious adverse events included 1 ulcer treated medically in the RYGB group and 2 rehospitalizations for dehydration in the LAGB group. CONCLUSIONS AND RELEVANCE This study highlights several potential challenges to successful completion of a larger RCT for treatment of T2DM and obesity in patients with a body mass index of 30 to 40, including the difficulties associated with recruiting and randomizing patients to surgical vs nonsurgical interventions. Preliminary results show that RYGB was the most effective treatment, followed by LAGB for weight loss and T2DM outcomes at 1 year.
引用
收藏
页码:707 / 715
页数:9
相关论文
共 23 条
[1]   Health Benefits of Gastric Bypass Surgery After 6 Years [J].
Adams, Ted D. ;
Davidson, Lance E. ;
Litwin, Sheldon E. ;
Kolotkin, Ronette L. ;
LaMonte, Michael J. ;
Pendleton, Robert C. ;
Strong, Michael B. ;
Vinik, Russell ;
Wanner, Nathan A. ;
Hopkins, Paul N. ;
Gress, Richard E. ;
Walker, James M. ;
Cloward, Tom V. ;
Nuttall, R. Tom ;
Hammoud, Ahmad ;
Greenwood, Jessica L. J. ;
Crosby, Ross D. ;
McKinlay, Rodrick ;
Simper, Steven C. ;
Smith, Sherman C. ;
Hunt, Steven C. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2012, 308 (11) :1122-1131
[2]   Relationship Between Treatment Preference and Weight Loss in the Context of a Randomized Controlled Trial [J].
Borradaile, Kelley E. ;
Halpern, Scott D. ;
Wyatt, Holly R. ;
Klein, Samuel ;
Hill, James O. ;
Bailer, Brooke ;
Brill, Carrie ;
Stein, Richard I. ;
Miller, Bernard V., III ;
Foster, Gary D. .
OBESITY, 2012, 20 (06) :1218-1222
[3]   Look AHEAD (Action for Health in Diabetes): design and methods for a clinical trial of weight loss for the prevention of cardiovascular disease in type 2 diabetes [J].
Brancati, F ;
Charleston, J ;
Cheskin, L ;
Clark, J ;
DiGregorio-Celnik, D ;
Friedman-Donze, L ;
Rubin, R ;
Stewart, K ;
Bray, GA ;
DeLee, DG ;
Boss, KR ;
Greenway, FL ;
Lovejoy, JC ;
Ryan, DH ;
Williamson, DA ;
West, DS ;
DiLillo, V ;
Raczynski, JM ;
Lewis, CE ;
Oberman, A ;
Thomas, S ;
Nathan, DM ;
Horton, ES ;
Turgeon, H ;
Jackson, SD ;
Blackburn, GL ;
Delahanty, L ;
Steiner, B ;
Cagliero, E ;
Mantzoros, C ;
Hill, JO ;
Phillipp, J ;
Hamman, RF ;
Schwartz, R ;
Regensteiner, J ;
Van Dorsten, B ;
McDermott, MT ;
Dills, DG ;
Foreyt, JP ;
Reeves, RS ;
Pownell, HJ ;
Balasubramanyam, A ;
Jones, PH ;
Saad, MF ;
Jinagouda, S ;
Chiu, K ;
Morales, L ;
Ghazarian, S ;
Navarrete, G ;
Iqbal, N .
CONTROLLED CLINICAL TRIALS, 2003, 24 (05) :610-628
[4]   How Do We Define Cure of Diabetes? [J].
Buse, John B. ;
Caprio, Sonia ;
Cefalu, William T. ;
Ceriello, Antonio ;
Del Prato, Stefano ;
Inzucchi, Silvio E. ;
McLaughlin, Sue ;
Phillips, Gordon L., II ;
Robertson, R. Paul ;
Rubino, Francesco ;
Kahn, Richard ;
Kirkman, M. Sue .
DIABETES CARE, 2009, 32 (11) :2133-2135
[5]   Bariatric Surgery and Prevention of Type 2 Diabetes in Swedish Obese Subjects [J].
Carlsson, Lena M. S. ;
Peltonen, Markku ;
Ahlin, Sofie ;
Anveden, Asa ;
Bouchard, Claude ;
Carlsson, Bjorn ;
Jacobson, Peter ;
Lonroth, Hans ;
Maglio, Cristina ;
Naslund, Ingmar ;
Pirazzi, Carlo ;
Romeo, Stefano ;
Sjoholm, Kajsa ;
Sjostrom, Elisabeth ;
Wedel, Hans ;
Svensson, Per-Arne ;
Sjostrom, Lars .
NEW ENGLAND JOURNAL OF MEDICINE, 2012, 367 (08) :695-704
[6]   Adjustable gastric banding and conventional therapy for type 2 diabetes - A randomized controlled trial [J].
Dixon, John B. ;
O'Brien, Paul E. ;
Playfair, Julie ;
Chapman, Leon ;
Schachter, Linda M. ;
Skinner, Stewart ;
Proietto, Joseph ;
Bailey, Michael ;
Anderson, Margaret .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2008, 299 (03) :316-323
[7]  
DPP Res Grp, 2002, DIABETES CARE, V25, P2165
[8]  
Espeland M, 2007, DIABETES CARE, V30, P1374
[9]   Longitudinal Assessment of Bariatric Surgery (LABS): Retention strategy and results at 24 months [J].
Gourash, William F. ;
Ebel, Faith ;
Lancaster, Kathy ;
Adeniji, Abidemi ;
Iacono, Laurie Koozer ;
Eagleton, Jessie K. ;
MacDougall, Anne ;
Cassady, Chelsea ;
Ericson, Hallie ;
Pories, Walter ;
Wolfe, Bruce M. ;
Belle, Steven H. .
SURGERY FOR OBESITY AND RELATED DISEASES, 2013, 9 (04) :514-519
[10]   Association of an Intensive Lifestyle Intervention With Remission of Type 2 Diabetes [J].
Gregg, Edward W. ;
Chen, Haiying ;
Wagenknecht, Lynne E. ;
Clark, Jeanne M. ;
Delahanty, Linda M. ;
Bantle, John ;
Pownall, Henry J. ;
Johnson, Karen C. ;
Safford, Monika M. ;
Kitabchi, Abbas E. ;
Pi-Sunyer, F. Xavier ;
Wing, Rena R. ;
Bertoni, Alain G. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2012, 308 (23) :2489-2496