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Intensive lifestyle modifications with or without liraglutide 3 mg vs. sleeve gastrectomy: A three-arm non-randomised, controlled, pilot study - 18/06/18

Doi : 10.1016/j.diabet.2017.12.007 
E. Capristo a, S. Panunzi b, A. De Gaetano b, M. Raffaelli c, C. Guidone a, A. Iaconelli a, L. L’Abbate b, A.L. Birkenfeld d, e, f, R. Bellantone c, S.R. Bornstein d, e, G. Mingrone a, e,
a Department of Internal Medicine, Catholic University, Rome, Italy 
b CNR-Institute of Systems Analysis and Computer Science (IASI), BioMatLab, Rome, Italy 
c Department of Surgery, Catholic University, Rome, Italy 
d Department of Medicine III, Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden, Germany 
e Diabetes and Nutritional Sciences, Hodgkin Building, Guy's Campus, King's College London, London, United Kingdom 
f Paul Langerhans Institute Dresden of the Helmholtz Centre Munich at University Hospital Dresden, a member of the German Centre for Diabetes Research (DZD e.V.), Dresden, Germany 

Corresponding author. Department of Internal Medicine, Catholic University, 8, Largo A. Gemelli, 00168 Rome, Italy.Department of Internal Medicine, Catholic University, 8, Largo A. Gemelli, 00168 Rome, Italy.

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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 813kcal of a very low-calorie diet (VLCD) for 1 month, followed by a diet of 12kcal/kg body weight of high protein and high fat for 11 months plus 30min of brisk walking daily and at least 3h 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 43kg with SG, 26kg with ILM+liraglutide and 15kg with ILM alone. Lean body mass reductions were −11.6kg with SG, −6.3kg with ILM and −8.3kg 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 3.0mg 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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Keywords : Body composition, Bariatric surgery, Lifestyle modifications, Liraglutide, Obesity, Very low-calorie diet


Plan


 Protocol ID 0002017056 at clinicaltrials.gov.


© 2017  Elsevier Masson SAS. Tous droits réservés.
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Vol 44 - N° 3

P. 235-242 - juin 2018 Retour au numéro
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