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

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.

• Authors: E Capristo, S Panunzi, A De Gaetano, M Raffaelli, C Guidone, A Iaconelli, L L'Abbate, A L Birkenfeld, R Bellantone, S R Bornstein, G Mingrone
• Journal: Diabetes & metabolism (Diabetes Metab) Vol. 44 Issue 3 Pg. 235-242 (Jun 2018) ISSN: 1878-1780 [Electronic] France
• PMID: 29398254 (Publication Type: Comparative Study, Controlled Clinical Trial, Journal Article)
• Copyright: Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Chemical References

• Hypoglycemic Agents
• Liraglutide

Topics

• Adult
• Combined Modality Therapy
• Female
• Gastrectomy
• Humans
• Hypoglycemic Agents (therapeutic use)
• Life Style
• Liraglutide (therapeutic use)
• Male
• Middle Aged
• Obesity, Morbid (diet therapy, drug therapy, surgery, therapy)
• Pilot Projects
• Treatment Outcome