Intensive lifestyle modifications with or without liraglutide 3 mg vs. sleeve gastrectomy: A three-arm non-randomised, controlled, pilot study
Open accessAbstract
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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In that study, despite greater weight loss with bariatric surgery, changes in fasting plasma glucose and lipid profiles favored the liraglutide-treated group.
“Despite the greater weight loss with bariatric surgery, changes in fasting plasma glucose and lipid profiles favored the liraglutide-treated group.”
From The societal implications of using glucagon-like peptide-1 receptor agonists for the treatment of obesity (2025) · cites this paper as [96]
The study reports greater weight loss with sleeve gastrectomy and lower fasting glucose in the intensive lifestyle modification plus liraglutide group. Its lipid results favor liraglutide for triglycerides and HDL cholesterol, but not uniformly across the lipid profile: the discussion reports a larger cholesterol reduction with surgery. The claim therefore overgeneralizes the lipid comparison. (LLM, conf=0.84)
Experimental — accuracy not yet measuredIn a recent non-randomized study, after 1 year, sleeve gastrectomy resulted in the greatest weight loss (43.4 kg [32%]) among patients without diabetes eligible for bariatric surgery.
“After 1 year, surgery resulted in the greatest weight loss (43.4 kg [32%]), but behavioral modifications with 3.0 mg liraglutide also resulted in a significantly greater weight loss (26.3 kg [24%]) than behavioral modifications alone (15.4 kg [14%]).”
From The societal implications of using glucagon-like peptide-1 receptor agonists for the treatment of obesity (2025) · cites this paper as [96]
In that study, behavioral modifications with 3.0 mg liraglutide resulted in significantly greater weight loss (26.3 kg [24%]) than behavioral modifications alone (15.4 kg [14%]).
“After 1 year, surgery resulted in the greatest weight loss (43.4 kg [32%]), but behavioral modifications with 3.0 mg liraglutide also resulted in a significantly greater weight loss (26.3 kg [24%]) than behavioral modifications alone (15.4 kg [14%]).”
From The societal implications of using glucagon-like peptide-1 receptor agonists for the treatment of obesity (2025) · cites this paper as [96]
Among the included publications, 47 were randomized control trials, 33 were real-world evidence studies, and 1 was a nonrandomized pilot study.
“Among these, 47 publications were randomized control trials (RCTs), 33 were real-world evidence (RWE) studies, and 1 study was a nonrandomized pilot study [37].”
From Symptomatic Adverse Events and Quality of Life Related to Incretin-Based Medicines for Obesity: A Systematic Review Involving >400,000 Subjects (2025) · cites this paper as [37]
Changes to lean body mass and bone mineral density were reported in 8 of the 81 identified publications.
“Changes to lean body mass (LBM) defined as total body weight minus fat mass, and bone mineral density were reported in 8 of the 81 identified publications [12,13,37,45,50,73,75,87].”
From Symptomatic Adverse Events and Quality of Life Related to Incretin-Based Medicines for Obesity: A Systematic Review Involving >400,000 Subjects (2025) · cites this paper as [37]
Two studies compared IBTs with lifestyle modification programs and one compared liraglutide and lifestyle modification with sleeve gastrectomy.
“while two studies compared IBTs with lifestyle modification programs [61,90] and one compared liraglutide and lifestyle modification with sleeve gastrectomy [37]”
From Symptomatic Adverse Events and Quality of Life Related to Incretin-Based Medicines for Obesity: A Systematic Review Involving >400,000 Subjects (2025) · cites this paper as [37]
Only one publication from this SLR recorded calorie intake, and none recorded dietary composition.
“only one publication from this SLR recorded calorie intake [37], and none recorded dietary composition.”
From Symptomatic Adverse Events and Quality of Life Related to Incretin-Based Medicines for Obesity: A Systematic Review Involving >400,000 Subjects (2025) · cites this paper as [37]
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- Authors
- 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.
- Affiliations
- National Research Council (IT)
- Università Cattolica del Sacro Cuore (IT)
- King's College London (GB)
- Corresponding author
- Mingrone, G.
- ORCID
- Venue
- Diabetes & Metabolism
- Publisher
- Elsevier BV
- Published
- 2018-06
- Volume
- 44
- Issue
- 3
- Pages
- 235-242
- ISSN
- 1262-3636 (ISSN-L)
- OpenAlex
- W2776835120
- Cited by
- 31
- References
- 27
- Citations by year
- 2026: 6 · 2025: 5 · 2023: 3 · 2022: 4 · 2021: 2 · 2020: 6 · 2019: 3 · 2018: 2
- FWCI
- 3.08
- Type
- journal article
- Language
- en
- Update notices
- erratum (2020-04-01)
- Open access
- green
- kclpure.kcl.ac.uk
- Licence
- Locations
- Diabetes & Metabolism (publishedVersion)
- PubMed (publishedVersion)
- Research Portal (King's College London) (acceptedVersion, cc-by-nc-nd)
- PuSH - Publication Server of Helmholtz Zentrum München (submittedVersion)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion)
- Funders
- Australian Catholic University
- Deutsche Forschungsgemeinschaft (GM)
- Topics
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Obesity, Physical Activity, Diet
- Keywords
- obesity, intensive lifestyle intervention, liraglutide, sleeve gastrectomy, very low calorie diet, weight loss, body mass index, lean body mass, prediabetes, insulin resistance, cardiometabolic risk factors, non-diabetic patients, bariatric surgery alternatives, physical activity, GLP-1 receptor agonists
- MeSH terms
- Liraglutide, Adult, Combined Modality Therapy, Female, Gastrectomy, Humans, Hypoglycemic Agents, Life Style, Male, Middle Aged, Obesity, Morbid, Pilot Projects, Treatment Outcome
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