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 BMI 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.
Capristo, E., Panunzi, S., De Gaetano, A., Raffaelli, M., Guidone, C., Iaconelli, A., L'Abbate, L., Birkenfeld, A. L., Bellantone, R. D. A., Bornstein, S. R., Mingrone, G., Intensive lifestyle modifications with or without liraglutide 3mg vs. sleeve gastrectomy: A three-arm non-randomised, controlled, pilot study, <<DIABETES & METABOLISM>>, 2018; (44(3)): 235-242. [doi:10.1016/j.diabet.2017.12.007] [http://hdl.handle.net/10807/147646]
Intensive lifestyle modifications with or without liraglutide 3mg vs. sleeve gastrectomy: A three-arm non-randomised, controlled, pilot study
Capristo, Esmeralda;Raffaelli, Marco;Iaconelli, Amerigo;Bellantone, Rocco Domenico Alfonso;Mingrone, Geltrude
2018
Abstract
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 BMI 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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