| |
DiaSurg 2 trial - surgical vs. medical treatment of insulin-dependent type 2 diabetes mellitus in patients with a body mass index between 26 and 35?kg/m2: study protocol of a randomized control
- 作者:Hannes G Kenngott (5)
Gabriella Clemens (5) Matthias Gondan (6) Jonas Senft (5) Markus K Diener (5) (7) Gottfried Rudofsky (8) Peter P Nawroth (8) Markus W Büchler (5) Lars Fischer (5) Beat P Müller-Stich (5)
- 刊名:Trials
- 出版年:2013
- 出版时间:December 2013
- 年:2013
- 卷:14
- 期:1
- 全文大小:344KB
- 参考文献:1. Wild S, Roglic G, Green A, Sicree R, King H: Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. / Diabetes Care 2004, 27:1047-053. href="http://dx.doi.org/10.2337/diacare.27.5.1047">CrossRef
2. International Diabetes Federation: / IDF Diabetes Atlas, 5th edn. [Internet]. International Diabetes Federation. Brussels, Belgium: Verfügbar unter; 2012. href="http://www.idf.org/diabetesatlas" class="a-plus-plus">http://www.idf.org/diabetesatlas 3. Rathmann W, Strassburger K, Heier M, Holle R, Thorand B, Giani G: Incidence of type 2 diabetes in the elderly German population and the effect of clinical and lifestyle risk factors: KORA S4/F4 cohort study. / Diabet Med 2009, 26:1212-219. href="http://dx.doi.org/10.1111/j.1464-5491.2009.02863.x">CrossRef 4. DiabetesDE - Deutsche Diabetes-Hilfe, Berlin, Germany: / Deutscher Gesundheitsbericht Diabetes 2013 [Internet]. Kirchheim-Verlag; [zitiert 5. Dezember 2012]. Verfügbar unter. [href="http://www.diabetesde.org" class="a-plus-plus">http://www.diabetesde.org] [zitiert 5. Dezember 2012]. Verfügbar unter. 5. Pinhas-Hamiel O, Zeitler P: Acute and chronic complications of type 2 diabetes mellitus in children and adolescents. / Lancet 2007, 369:1823-831. href="http://dx.doi.org/10.1016/S0140-6736(07)60821-6">CrossRef 6. UK Prospective Diabetes Study (UKPDS) Group: Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). / Lancet 1998, 352:837-53. href="http://dx.doi.org/10.1016/S0140-6736(98)07019-6">CrossRef 7. K?ster I, Huppertz E, Hauner H, Schubert I: Direct costs of diabetes mellitus in Germany - CoDiM 2000-007. / Exp Clin Endocrinol Diabetes 2011, 119:377-85. href="http://dx.doi.org/10.1055/s-0030-1269847">CrossRef 8. Nathan DM, Buse JB, Davidson MB, Heine RJ, Holman RR, Sherwin R: Management of hyperglycemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. / Diabetes Care 2006, 29:1963-972. href="http://dx.doi.org/10.2337/dc06-9912">CrossRef 9. Matthaei S, Bierwirth R, Fritsche A, Gallwitz B, H?ring H-U, Joost H-G: Medical antihyperglycaemic treatment of type 2 diabetes mellitus: update of the evidence-based guideline of the German Diabetes Association. / Exp Clin Endocrinol Diabetes 2009, 117:522-57. href="http://dx.doi.org/10.1055/s-0029-1239559">CrossRef 10. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HAW: 10-year follow-up of intensive glucose control in type 2 diabetes. / N Engl J Med 2008, 359:1577-589. href="http://dx.doi.org/10.1056/NEJMoa0806470">CrossRef 11. Currie CJ, Peters JR, Tynan A, Evans M, Heine RJ, Bracco OL: Survival as a function of HbA(1c) in people with type 2 diabetes: a retrospective cohort study. / Lancet 2010, 375:481-89. href="http://dx.doi.org/10.1016/S0140-6736(09)61969-3">CrossRef 12. Zoungas S, Patel A, Chalmers J, De Galan BE, Li Q, Billot L: Severe hypoglycemia and risks of vascular events and death. / N Engl J Med 2010, 363:1410-418. href="http://dx.doi.org/10.1056/NEJMoa1003795">CrossRef 13. Boussageon R, Bejan-Angoulvant T, Saadatian-Elahi M, Lafont S, Bergeonneau C, Kassa? B: Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and microvascular events in type 2 diabetes: meta-analysis of randomised controlled trials. / BMJ 2011, 343:d4169. href="http://dx.doi.org/10.1136/bmj.d4169">CrossRef 14. Hemmingsen B, Lund SS, Gluud C, Vaag A, Almdal T, Hemmingsen C: Intensive glycaemic control for patients with type 2 diabetes: systematic review with meta-analysis and trial sequential analysis of randomised clinical trials. / BMJ 2011, 343:d6898. href="http://dx.doi.org/10.1136/bmj.d6898">CrossRef 15. Meisinger C, D?ring A, Thorand B, Heier M, L?wel H: Body fat distribution and risk of type 2 diabetes in the general population: are there differences between men and women? The MONICA/KORA Augsburg cohort study. / Am J Clin Nutr 2006, 84:483-89. 16. SAGES Guidelines Committee: SAGES guideline for clinical application of laparoscopic bariatric surgery. / Surg Obes Relat Dis 2009, 5:387-05. href="http://dx.doi.org/10.1016/j.soard.2009.01.010">CrossRef 17. Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ: Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. / Am J Med 2009, 122:248-56. e5 href="http://dx.doi.org/10.1016/j.amjmed.2008.09.041">CrossRef 18. Mingrone G, Panunzi S, De Gaetano A, Guidone C, Iaconelli A, Leccesi L: Bariatric surgery versus conventional medical therapy for type 2 diabetes. / N Engl J Med 2012, 366:1577-585. href="http://dx.doi.org/10.1056/NEJMoa1200111">CrossRef 19. Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier C: Bariatric surgery versus intensive medical therapy in obese patients with diabetes. / N Engl J Med 2012, 366:1567-576. href="http://dx.doi.org/10.1056/NEJMoa1200225">CrossRef 20. Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K: Bariatric surgery: a systematic review and meta-analysis. / JAMA 2004, 292:1724-737. href="http://dx.doi.org/10.1001/jama.292.14.1724">CrossRef 21. De Paula AL, Stival AR, Macedo A, Ribamar J, Mancini M, Halpern A: Prospective randomized controlled trial comparing 2 versions of laparoscopic ileal interposition associated with sleeve gastrectomy for patients with type 2 diabetes with BMI 21-4 kg/m(2). / Surg Obes Relat Dis 2010, 6:296-04. href="http://dx.doi.org/10.1016/j.soard.2009.10.005">CrossRef 22. Sj?str?m L, Lindroos A-K, Peltonen M, Torgerson J, Bouchard C, Carlsson B: Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. / N Engl J Med 2004, 351:2683-693. href="http://dx.doi.org/10.1056/NEJMoa035622">CrossRef 23. Rubino F, Marescaux J: Effect of duodenal-jejunal exclusion in a non-obese animal model of type 2 diabetes: a new perspective for an old disease. / Ann Surg 2004, 239:1-1. href="http://dx.doi.org/10.1097/01.sla.0000102989.54824.fc">CrossRef 24. Lee W-J, Ser K-H, Chong K, Lee Y-C, Chen S-C, Tsou J-J: Laparoscopic sleeve gastrectomy for diabetes treatment in nonmorbidly obese patients: efficacy and change of insulin secretion. / Surgery 2010, 147:664-69. href="http://dx.doi.org/10.1016/j.surg.2009.10.059">CrossRef 25. Lee W-J, Wang W, Lee Y-C, Huang M-T, Ser K-H, Chen J-C: Effect of laparoscopic mini-gastric bypass for type 2 diabetes mellitus: comparison of BMI-gt;-5 and <35 kg/m2. / J Gastrointest Surg 2008, 12:945-52. href="http://dx.doi.org/10.1007/s11605-007-0319-4">CrossRef 26. Abbatini F, Capoccia D, Casella G, Coccia F, Leonetti F, Basso N: Type 2 diabetes in obese patients with body mass index of 30-5 kg/m(2): sleeve gastrectomy versus medical treatment. / Surg Obes Relat Dis 2012, 8:20-4. href="http://dx.doi.org/10.1016/j.soard.2011.06.015">CrossRef 27. Lee W-J, Chong K, Ser K-H, Lee Y-C, Chen S-C, Chen J-C: Gastric bypass vs sleeve gastrectomy for type 2 diabetes mellitus: a randomized controlled trial. / Arch Surg 2011, 146:143-48. href="http://dx.doi.org/10.1001/archsurg.2010.326">CrossRef 28. Buchwald H, Estok R, Fahrbach K, Banel D, Sledge I: Trends in mortality in bariatric surgery: a systematic review and meta-analysis. / Surgery 2007, 142:621-32. discussion 632-35 href="http://dx.doi.org/10.1016/j.surg.2007.07.018">CrossRef 29. Donadelli SP, Junqueira-Franco MVM, De Mattos Donadelli CA, Salgado W Jr, Ceneviva R, Marchini JS: Daily vitamin supplementation and hypovitaminosis after obesity surgery. / Nutrition 2012, 28:391-96. href="http://dx.doi.org/10.1016/j.nut.2011.07.012">CrossRef 30. Boza C, Mu?oz R, Salinas J, Gamboa C, Klaassen J, Escalona A: Safety and efficacy of Roux-en-Y gastric bypass to treat type 2 diabetes mellitus in non-severely obese patients. / Obes Surg 2011, 21:1330-336. href="http://dx.doi.org/10.1007/s11695-011-0463-5">CrossRef 31. Gaede P, Vedel P, Larsen N, Jensen GVH, Parving H-H, Pedersen O: Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. / N Engl J Med 2003, 348:383-93. href="http://dx.doi.org/10.1056/NEJMoa021778">CrossRef 32. G?de P, Lund-Andersen H, Parving H-H, Pedersen O: Effect of a multifactorial intervention on mortality in type 2 diabetes. / N Engl J Med 2008, 358:580-91. href="http://dx.doi.org/10.1056/NEJMoa0706245">CrossRef 33. Higgins JPT, White IR, Wood AM: Imputation methods for missing outcome data in meta-analysis of clinical trials. / Clin Trials 2008, 5:225-39. href="http://dx.doi.org/10.1177/1740774508091600">CrossRef 34. Buyse M: Generalized pairwise comparisons of prioritized outcomes in the two-sample problem. / Stat Med 2010, 29:3245-257. href="http://dx.doi.org/10.1002/sim.3923">CrossRef 35. Zimmet P, Alberti KGMM: Surgery or medical therapy for obese patients with type 2 diabetes? / N Engl J Med 2012, 366:1635-636. href="http://dx.doi.org/10.1056/NEJMe1202443">CrossRef 36. Tahrani AA, Bailey CJ, Del Prato S, Barnett AH: Management of type 2 diabetes: new and future developments in treatment. / Lancet 2011, 378:182-97. href="http://dx.doi.org/10.1016/S0140-6736(11)60207-9">CrossRef 37. Dixon JB, Le Roux CW, Rubino F, Zimmet P: Bariatric surgery for type 2 diabetes. / Lancet 2012, 379:2300-311. href="http://dx.doi.org/10.1016/S0140-6736(12)60401-2">CrossRef 38. Umeda LM, Silva EA, Carneiro G, Arasaki CH, Geloneze B, Zanella MT: Early improvement in glycemic control after bariatric surgery and its relationships with insulin, GLP-1, and glucagon secretion in type 2 diabetic patients. / Obes Surg 2011, 21:896-01. href="http://dx.doi.org/10.1007/s11695-011-0412-3">CrossRef 39. Bose M, Teixeira J, Olivan B, Bawa B, Arias S, Machineni S: Weight loss and incretin responsiveness improve glucose control independently after gastric bypass surgery. / J Diabetes 2010, 2:47-5. href="http://dx.doi.org/10.1111/j.1753-0407.2009.00064.x">CrossRef 40. Camastra S, Gastaldelli A, Mari A, Bonuccelli S, Scartabelli G, Frascerra S: Early and longer term effects of gastric bypass surgery on tissue-specific insulin sensitivity and beta cell function in morbidly obese patients with and without type 2 diabetes. / Diabetologia 2011, 54:2093-102. href="http://dx.doi.org/10.1007/s00125-011-2193-6">CrossRef 41. Falkén Y, Hellstr?m PM, Holst JJ, N?slund E: Changes in glucose homeostasis after Roux-en-Y gastric bypass surgery for obesity at day three, two months, and one year after surgery: role of gut peptides. / J Clin Endocrinol Metab 2011, 96:2227-235. href="http://dx.doi.org/10.1210/jc.2010-2876">CrossRef 42. Mingrone G, Castagneto-Gissey L: Mechanisms of early improvement/resolution of type 2 diabetes after bariatric surgery. / Diabetes Metab 2009, 35:518-23. href="http://dx.doi.org/10.1016/S1262-3636(09)73459-7">CrossRef 43. Gerstein HC, Miller ME, Genuth S, Ismail-Beigi F, Buse JB, Goff DC Jr: Long-term effects of intensive glucose lowering on cardiovascular outcomes. / N Engl J Med 2011, 364:818-28. href="http://dx.doi.org/10.1056/NEJMoa1006524">CrossRef 44. Jiménez A, Casamitjana R, Flores L, Viaplana J, Corcelles R, Lacy A: Long-term effects of sleeve gastrectomy and Roux-en-Y gastric bypass surgery on type 2 diabetes mellitus in morbidly obese subjects. / Ann Surg 2012, 256:1023-029. href="http://dx.doi.org/10.1097/SLA.0b013e318262ee6b">CrossRef 45. Arterburn DE, Bogart A, Sherwood NE, Sidney S, Coleman KJ, Haneuse S: A multisite study of long-term remission and relapse of type 2 diabetes mellitus following gastric bypass. / Obes Surg 2013, 23:93-02. href="http://dx.doi.org/10.1007/s11695-012-0802-1">CrossRef 46. Carlsson LMS, Peltonen M, Ahlin S, Anveden A, Bouchard C, Carlsson B: Bariatric surgery and prevention of type 2 diabetes in Swedish obese subjects. / N Engl J Med 2012, 367:695-04. href="http://dx.doi.org/10.1056/NEJMoa1112082">CrossRef 47. Sj?str?m L, Narbro K, Sj?str?m CD, Karason K, Larsson B, Wedel H: Effects of bariatric surgery on mortality in Swedish obese subjects. / N Engl J Med 2007, 357:741-45. href="http://dx.doi.org/10.1056/NEJMoa066254">CrossRef 48. Demaria EJ, Winegar DA, Pate VW, Hutcher NE, Ponce J, Pories WJ: Early postoperative outcomes of metabolic surgery to treat diabetes from sites participating in the ASMBS bariatric surgery center of excellence program as reported in the bariatric outcomes longitudinal database. / Ann Surg 2010, 252:559-66. discussion 566-67 49. DePaula AL, Stival AR, DePaula CCL, Halpern A, Vencio S: Surgical treatment of type 2 diabetes in patients with BMI below 35: mid-term outcomes of the laparoscopic ileal interposition associated with a sleeve gastrectomy in 202 consecutive cases. / J Gastrointest Surg 2012, 16:967-76. href="http://dx.doi.org/10.1007/s11605-011-1807-0">CrossRef 50. Frenken M, Cho E-Y: Metabolic intestinal bypass surgery for type 2 diabetes in patients with a BMI <35 kg/m2: comparative analysis of 16 patients undergoing either BPD, BPD-DS, or RYGB. / Obes Facts 2011,4(Suppl 1):13-7. href="http://dx.doi.org/10.1159/000327038">CrossRef 51. Makary MA, Clark JM, Clarke JM, Shore AD, Magnuson TH, Richards T: Medication utilization and annual health care costs in patients with type 2 diabetes mellitus before and after bariatric surgery. / Arch Surg 2010,145(8):726-31. href="http://dx.doi.org/10.1001/archsurg.2010.150">CrossRef
- 作者单位:Hannes G Kenngott (5)
Gabriella Clemens (5) Matthias Gondan (6) Jonas Senft (5) Markus K Diener (5) (7) Gottfried Rudofsky (8) Peter P Nawroth (8) Markus W Büchler (5) Lars Fischer (5) Beat P Müller-Stich (5)
5. Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany 6. Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany 7. Study Center of the German Surgical Society (SDGC), University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany 8. Department of Medicine I and Clinical Chemistry, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany
文摘
Background Type 2 diabetes mellitus (T2DM) is a disease with high prevalence, associated with severe co-morbidities as well as being a huge burden on public health. It is known that glycemic control decreases long-term morbidity and mortality. The current standard therapy for T2DM is medical treatment. Several randomized controlled trials (RCTs) performed in obese patients showed remission of T2DM after bariatric surgery. Recent RCTs have shown bariatric procedures to produce a similar effect in non-morbidly and non-severely obese, insulin-dependent T2DM patients suggesting procedures currently used in bariatric surgery as new therapeutical approach in patients with T2DM. This study aims at investigating whether Roux-en-Y gastric bypass (RYGB) is an efficient treatment for non-severely obese T2DM patients in terms of preventing long-term complications and mortality. Methods The DiaSurg 2 trial is a multicenter, open randomized controlled trial comparing RYGB including standardized medical treatment if needed to exclusive standardized medical treatment of T2DM (control group). The primary endpoint is a composite time-to-event endpoint (cardiovascular death, myocardial infarction, coronary bypass, percutaneous coronary intervention, non-fatal stroke, amputation, surgery for peripheral atherosclerotic artery disease), with a follow-up period of 8?years. Insulin-dependent T2DM patients aged between 30 and 65?years will be included and randomly assigned to one of the two groups. The experimental group will receive RYGB and, if needed, standardized medical care, whereas the control group will receive exclusive standardized medical care, both according to the national treatment guidelines for T2DM. Statistical analysis is based on Cox proportional hazards regression for the intention-to-treat population. Assuming a loss to follow-up rate of 20%, 200 patients will be randomly allocated to the comparison groups. A total sample size of n--00 is sufficient to ensure 80% power in a two-tailed significance test at alpha--%. Discussion The DiaSurg2 trial will yield long-term data (8?years) on diabetes-associated morbidity and mortality in patients with insulin-dependent T2DM receiving either RYGB or standardized medical care. Trial registration The trial protocol has been registered in the German Clinical Trials Register DRKS00004550.
| |
NGLC 2004-2010.National Geological Library of China All Rights Reserved.
Add:29 Xueyuan Rd,Haidian District,Beijing,PRC. Mail Add: 8324 mailbox 100083
For exchange or info please contact us via email.
| |