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Capristo, E.* ; Panunzi, S.* ; De Gaetano, A.* ; Raffaelli, M.* ; Guidone, C.* ; Iaconelli, A.* ; L'Abbate, L.* ; Birkenfeld, A.L. ; Bellantone, R.* ; Bornstein, S.R.* ; Mingrone, G.*

Intensive lifestyle modifications with or without liraglutide 3 mg vs. sleeve gastrectomy: A three-arm non-randomised, controlled, pilot study.

Diabetes Metab. 44, 235-242 (2017)

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Background/Objectives. - As only 1% of clinically eligible subjects choose to undergo surgical treatment for obesity, other options should be investigated. This study aimed to assess the effects of intensive lifestyle modification (ILM) with or without 3-mg liraglutide daily vs. sleeve gastrectomy (SG) on BMI after 1 year.Subjects/methods. - In this study performed at an Italian university hospital, non-diabetic patients eligible for bariatric surgery were recruited from a weight-loss clinic and had the option to choose from three possible weight-loss programmes up to an allocation of 25 subjects in each arm matched by Bil and age. ILM consisted in 813 kcal of a very low-calorie diet (VLCD) for 1 month, followed by a diet of 12 kcal/kg body weight of high protein and high fat for 11 months plus 30 min of brisk walking daily and at least 3 h of aerobic exercise weekly. SG patients followed a VLCD for 1 month and a free diet thereafter. Patients were evaluated at baseline and at 1, 3, 6, 9 and 12 months.Results. - A total of 75 patients were enrolled; retention was 100% in the SG and 85% in the two medical arms. SG reduced BMI by 32% (P < 0.001 vs. medical arm), while ILM + liraglutide and ILM led to BMI reductions of 24% and 14%, respectively (P < 0.001). More women allocated themselves to the ILM + liraglutide group. Weight loss was 43 kg with SG, 26 kg with ILM + liraglutide and 15 kg with ILM alone. Lean body mass reductions were -11.6 kg with SG, -6.3 kg with ILM and -8.3 kg with ILM + liraglutide. Prevalence of prediabetes was significantly lower with ILM + liraglutide, and insulin resistance was reduced by about 70% by both ILM + liraglutide and SG vs. 39% by ILM alone. Cardiometabolic risk factors were greatly reduced in all three groups.Discussion. - At least in the short-term, liraglutide 3.0 mg once daily associated with drastic calorie- intake restriction and intensive physical activity promoted a 24% weight loss, which was almost two times greater than ILM alone and only about 25% less than with SG, while preserving lean body mass. Although this study was non-randomised, it was designed to explore the efficacy of medical treatments for obesity in everyday clinical practice.

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