Journal
BMJ OPEN
Volume 9, Issue 11, Pages -Publisher
BMJ PUBLISHING GROUP
DOI: 10.1136/bmjopen-2019-031431
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Funding
- Novo Nordisk Foundation [NNF16OC0019968]
- Novo Nordisk Foundation Center for Basic Metabolic Research synergy grant
- Helsefonden
- Faculty of Health and Medical Sciences, University of Copenhagen
- Danish Diabetes Academy
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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/ m(2)) 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.
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