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. 2019 Nov 2;9(11):e031431.
doi: 10.1136/bmjopen-2019-031431.

Protocol for a randomised controlled trial of the combined effects of the GLP-1 receptor agonist liraglutide and exercise on maintenance of weight loss and health after a very low-calorie diet

Simon Birk Kjær Jensen #  1   2 , Julie Rehné Lundgren #  1   2 , Charlotte Janus #  1   2 , Christian Rimer Juhl  1   2 , Lisa Møller Olsen  1   2 , Mads Rosenkilde  1   2 , Jens Juul Holst  1   2 , Bente Merete Stallknecht  1 , Sten Madsbad  3 , Signe Sørensen Torekov  4   2
Affiliations

Protocol for a randomised controlled trial of the combined effects of the GLP-1 receptor agonist liraglutide and exercise on maintenance of weight loss and health after a very low-calorie diet

Simon Birk Kjær Jensen et al. BMJ Open. .

Abstract

Introduction: The success rate of weight loss maintenance is limited. Therefore, the purpose of this study is to investigate the maintenance of weight loss and immunometabolic health outcomes after diet-induced weight loss followed by 1-year treatment with a glucagon-like peptide-1 receptor agonist (liraglutide), physical exercise or the combination of both treatments as compared with placebo in individuals with obesity.

Methods and analysis: This is an investigator-initiated, randomised, placebo-controlled, parallel group trial. We will enrol expectedly 200 women and men (age 18-65 years) with obesity (body mass index 32-43 kg/m2) to adhere to a very low-calorie diet (800 kcal/day) for 8 weeks in order to lose at least 5% of body weight. Subsequently, participants will be randomised in a 1:1:1:1 ratio to one of four study groups for 52 weeks: (1) placebo, (2) exercise 150 min/week+placebo, (3) liraglutide 3.0 mg/day and (4) exercise 150 min/week+liraglutide 3.0 mg/day. The primary endpoint is change in body weight from randomisation to end-of-treatment.

Ethics and dissemination: The trial has been approved by the ethical committee of the Capital Region of Denmark and the Danish Medicines Agency. The trial will be conducted in agreement with the Declaration of Helsinki and monitored to follow the guidelines for good clinical practice. Results will be submitted for publication in international peer-reviewed scientific journals.

Trial registration number: 2015-005585-32.

Keywords: GLP-1 receptor agonist; exercise; liraglutide; obesity; weight loss; weight loss maintenance.

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Conflict of interest statement

Competing interests: SST has received research grants from Novo Nordisk. SM has received research grants from Novo Nordisk and Boehringer Ingelheim; lecture fees from AstraZeneca, Boehringer Ingelheim, Bristol-Meyers Squibb, Eli Lilly, Merck Sharp & Dohme, Novartis, Novo Nordisk and Sanofi Aventis; and is a member of advisory boards of AstraZeneca, Boehringer Ingelheim, Bristol-Meyers Squibb, Eli Lilly, Intarcia Therapeutics, Johnson & Johnson, Merck Sharp & Dohme, Novartis, Novo Nordisk and Sanofi Aventis. JJH has served on advisory panels for GlaxoSmithKline, Novo Nordisk, Zealand Pharma, AstraZeneca, MSD, Intarcia and Hanmi and as a consultant for Novo Nordisk, and has received research support from Merck, Sharp & Dohme.

Figures

Figure 1
Figure 1
Study design.
See this image and copyright information in PMC

References

    1. Akram D, Astrup A, Atinmo T, et al. . Obesity: preventing and managing the global epidemic. Tech Rep Ser 2000. - PubMed
    1. Abdelaal M, le Roux CW, Docherty NG. Morbidity and mortality associated with obesity. Ann Transl Med 2017;5 10.21037/atm.2017.03.107 - DOI - PMC - PubMed
    1. Jensen MD, Ryan DH, Apovian CM, et al. . AHA/ACC/TOS guideline for the management of overweight and obesity in adults. Circulation 2013;2014:S102–38. - PMC - PubMed
    1. Garvey WT, Mechanick JI, Brett EM, et al. . American association of clinical endocrinologists and American College of endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract 2016;22:1–203. 10.4158/EP161365.GL - DOI - PubMed
    1. Nordmann AJ, Nordmann A, Briel M, et al. . Effects of low-carbohydrate vs low-fat diets on weight loss and cardiovascular risk factors: a meta-analysis of randomized controlled trials. Arch Intern Med 2006;166:285–93. 10.1001/archinte.166.3.285 - DOI - PubMed

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