Adjunctive liraglutide treatment in patients with persistent or recurrent type 2 diabetes after metabolic surgery (GRAVITAS): a randomised, double-blind, placebo-controlled trial

The Lancet Diabetes and Endocrinology

Volumn 7, Issue 7, 2019, Pages 549-559

  Miras, Alexander Dimitri ^a   Pérez Pevida, Belén ^a   Aldhwayan, Madhawi ^a   Kamocka, Anna ^a   McGlone, Emma Rose ^a   Al Najim, Werd ^a,b   Chahal, Harvinder ^a   Batterham, Rachel L ^c,d   McGowan, Barbara ^e   Khan, Omar ^f   Greener, Veronica ^g   Ahmed, Ahmed R ^a   Petrie, Aviva ^h   Scholtz, Samantha ^a   Bloom, Stephen R ^a   Tan, Tricia M ^a  

^a IMPERIAL COLLEGE HEALTHCARE NHS TRUST   (United Kingdom)

^b UNIVERSITY COLLEGE DUBLIN   (Ireland)

^c UNIVERSITY COLLEGE LONDON   (United Kingdom)

^d UNIVERSITY COLLEGE LONDON HOSPITALS   (United Kingdom)

^e GUY'S AND ST THOMAS' NHS FOUNDATION TRUST   (United Kingdom)

^f ST GEORGE'S UNIVERSITY HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

^g CHELSEA AND WESTMINSTER HOSPITAL NHS FOUNDATION TRUST   (United Kingdom)

^h UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

HEMOGLOBIN A1C; LIRAGLUTIDE; PLACEBO; ANTIDIABETIC AGENT;

ADD ON THERAPY; ARTICLE; BODY WEIGHT; CALORIC INTAKE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; ENGLAND; GASTRECTOMY; GASTROINTESTINAL SYMPTOM; GLYCEMIC CONTROL; HIGH CALORIE DIET; HUMAN; LINEAR REGRESSION ANALYSIS; MAJOR CLINICAL STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; OBESITY; PHYSICAL ACTIVITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; ROUX-EN-Y GASTRIC BYPASS; UNITED KINGDOM; VERTICAL SLEEVE GASTRECTOMY; AGED; BARIATRIC SURGERY; FEMALE; MALE; MIDDLE AGED; POSTOPERATIVE COMPLICATION;

AGED; BARIATRIC SURGERY; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; LIRAGLUTIDE; MALE; MIDDLE AGED; POSTOPERATIVE COMPLICATIONS;

EID: 85067310055     PISSN: 22138587     EISSN: 22138595     Source Type: Journal    
DOI: 10.1016/S2213-8587(19)30157-3     Document Type: Article

References (37)

1. Rubino, F, Nathan, DM, Eckel, RH, et al. Metabolic surgery in the treatment algorithm for type 2 diabetes: a joint statement by international diabetes organizations. Diabetes Care 39 (2016), 861–877.
2. Yu, J, Zhou, X, Li, L, et al. The long-term effects of bariatric surgery for type 2 diabetes: systematic review and meta-analysis of randomized and non-randomized evidence. Obes Surg 25 (2015), 143–158.
3. Schauer, PR, Bhatt, DL, Kirwan, JP, et al. Bariatric surgery versus intensive medical therapy for diabetes—5-year outcomes. N Engl J Med 376 (2017), 641–651.
4. Aron-Wisnewsky, J, Sokolovska, N, Liu, Y, et al. The advanced-DiaRem score improves prediction of diabetes remission 1 year post-Roux-en-Y gastric bypass. Diabetologia 60 (2017), 1892–1902.
5. Still, CD, Wood, GC, Benotti, P, et al. Preoperative prediction of type 2 diabetes remission after Roux-en-Y gastric bypass surgery: a retrospective cohort study. Lancet Diabetes Endocrinol 2 (2014), 38–45.
6. Yu, Y, Klem, ML, Kalarchian, MA, Ji, M, Burke, LE, Predictors of weight regain after sleeve gastrectomy: an integrative review. Surg Obes Relat Dis, 2019 published online March 20. DOI:10.1016/j.soard.2019.02.009.
7. le Roux, CW, Aylwin, SJ, Batterham, RL, et al. Gut hormone profiles following bariatric surgery favor an anorectic state, facilitate weight loss, and improve metabolic parameters. Ann Surg 243 (2006), 108–114.
8. le Roux, CW, Welbourn, R, Werling, M, et al. Gut hormones as mediators of appetite and weight loss after Roux-en-Y gastric bypass. Ann Surg 246 (2007), 780–785.
9. Dirksen, C, Jorgensen, NB, Bojsen-Moller, KN, et al. Gut hormones, early dumping and resting energy expenditure in patients with good and poor weight loss response after Roux-en-Y gastric bypass. Int J Obes (Lond) 37 (2013), 1452–1459.
10. Nannipieri, M, Baldi, S, Mari, A, et al. Roux-en-Y gastric bypass and sleeve gastrectomy: mechanisms of diabetes remission and role of gut hormones. J Clin Endocrinol Metab 98 (2013), 4391–4399.
11. de Hollanda, A, Casals, G, Delgado, S, et al. Gastrointestinal hormones and weight loss maintenance following Roux-en-Y gastric bypass. J Clin Endocrinol Metab 100 (2015), 4677–4684.
12. Jiménez, A, Mari, A, Casamitjana, R, Lacy, A, Ferrannini, E, Vidal, J, GLP-1 and glucose tolerance after sleeve gastrectomy in morbidly obese subjects with type 2 diabetes. Diabetes 63 (2014), 3372–3377.
13. Fenske, WK, Bueter, M, Miras, AD, Ghatei, MA, Bloom, SR, le Roux, CW, Exogenous peptide YY3–36 and Exendin-4 further decrease food intake, whereas octreotide increases food intake in rats after Roux-en-Y gastric bypass. Int J Obes (Lond) 36 (2012), 379–384.
14. Pajecki, D, Halpern, A, Cercato, C, Mancini, M, de Cleva, R, Santo, MA, Short-term use of liraglutide in the management of patients with weight regain after bariatric surgery. Rev Col Bras Cir 40 (2013), 191–195.
15. Gorgojo-Martinez, JJ, Feo-Ortega, G, Serrano-Moreno, C, Effectiveness and tolerability of liraglutide in patients with type 2 diabetes mellitus and obesity after bariatric surgery. Surg Obes Relat Dis 12 (2016), 1856–1863.
16. Rye, P, Modi, R, Cawsey, S, Sharma, AM, Efficacy of high-dose liraglutide as an adjunct for weight loss in patients with prior bariatric surgery. Obes Surg 28 (2018), 3553–3558.
17. Creange, C, Lin, E, Ren-Fielding, C, Lofton, H, Use of liraglutide for weight loss in patients with prior bariatric surgery. Surg Obes Relat Dis, 12(suppl), 2016, S157.
18. Mechanick, JI, Youdim, A, Jones, DB, et al. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient—2013 update: cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery. Obesity (Silver Spring) 21:suppl 1 (2013), S1–S27.
19. Aasheim, ET, Aylwin, SJ, Radhakrishnan, ST, et al. Assessment of obesity beyond body mass index to determine benefit of treatment. Clin Obes 1 (2011), 77–84.
20. Brennan, C, Worrall-Davies, A, McMillan, D, Gilbody, S, House, A, The Hospital Anxiety and Depression Scale: a diagnostic meta-analysis of case-finding ability. J Psychosom Res 69 (2010), 371–378.
21. Smarr, KL, Keefer, AL, Measures of depression and depressive symptoms: Beck Depression Inventory-II (BDI-II), Center for Epidemiologic Studies Depression Scale (CES-D), Geriatric Depression Scale (GDS), Hospital Anxiety and Depression Scale (HADS), and Patient Health Questionnaire-9 (PHQ-9). Arthritis Care Res (Hoboken) 63:suppl 11 (2011), S454–S466.
22. Snaith, RP, The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes, 1, 2003, 29.
23. van Strien, T, Frijters, JER, Bergers, GPA, Defares, PB, The Dutch Eating Behavior Questionnaire (DEBQ) for assessment of restrained, emotional, and external eating behavior. Int J Eat Disord 5 (1986), 295–315.
24. Wardle, J, Eating style: a validation study of the Dutch Eating Behaviour Questionnaire in normal subjects and women with eating disorders. J Psychosom Res 31 (1987), 161–169.
25. Babor, TF, Higgins-Biddle, JC, Saunders, JB, Monteiro, MG, AUDIT: The Alcohol Use Disorders Identification Test guidelines for use in primary care. https://www.who.int/substance_abuse/publications/audit/en/, 2001. (Accessed 27 May 2019)
26. Htike, ZZ, Zaccardi, F, Papamargaritis, D, Webb, DR, Khunti, K, Davies, MJ, Efficacy and safety of glucagon-like peptide-1 receptor agonists in type 2 diabetes: a systematic review and mixed-treatment comparison analysis. Diabetes Obes Metab 19 (2017), 524–536.
27. Tan, T, Behary, P, Tharakan, G, et al. The effect of a subcutaneous infusion of GLP-1, OXM, and PYY on energy intake and expenditure in obese volunteers. J Clin Endocrinol Metab 102 (2017), 2364–2372.
28. Nauck, MA, Kahle, M, Baranov, O, Deacon, CF, Holst, JJ, Addition of a dipeptidyl peptidase-4 inhibitor, sitagliptin, to ongoing therapy with the glucagon-like peptide-1 receptor agonist liraglutide: a randomized controlled trial in patients with type 2 diabetes. Diabetes Obes Metab 19 (2017), 200–207.
29. Shah, A, Levesque, K, Pierini, E, et al. Effect of sitagliptin on glucose control in type 2 diabetes mellitus after Roux-en-Y gastric bypass surgery. Diab Obes Metab 20 (2018), 1018–1023.
30. Kheniser, K, Kashyap, SR, Canagliflozin versus placebo for post-bariatric surgery patients with persistent type II diabetes: a randomized controlled trial (CARAT). Diab Obes Metab 19 (2017), 609–610.
31. Miras, AD, le Roux, CW, Surgery: the new gold-standard—medical gastric bypass. Nat Rev Endocrinol 14 (2018), 257–258.
32. King, WC, Belle, SH, Hinerman, AS, Mitchell, JE, Steffen, KJ, Courcoulas, AP, Patient behaviors and characteristics related to weight regain after Roux-en-Y gastric bypass: a multicenter prospective cohort study. Ann Surg, 2019 published online April 4. DOI:10.1097/SLA.0000000000003281.
33. Scholtz, S, Miras, AD, Chhina, N, et al. Obese patients after gastric bypass surgery have lower brain-hedonic responses to food than after gastric banding. Gut 63 (2014), 891–902.
34. Subramaniam, K, Low, WY, Lau, PC, et al. Eating behaviour predicts weight loss six months after bariatric surgery: a longitudinal study. Nutrients, 10, 2018, E1616.
35. Al-Najim, W, Docherty, NG, le Roux, CW, Food intake and eating behavior after bariatric surgery. Physiol Rev 98 (2018), 1113–1141.
36. Marso, SP, Daniels, GH, Brown-Frandsen, K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med 375 (2016), 311–322.
37. Suliman, M, Buckley, A, Al Tikriti, A, et al. Routine clinical use of liraglutide 3 mg for the treatment of obesity: outcomes in non-surgical and bariatric surgery patients. Diabetes Obes Metab 21 (2019), 1498–1501.