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      Effects of liraglutide on gallbladder emptying: A randomized, placebo‐controlled trial in adults with overweight or obesity

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          Abstract

          Aims

          Treatment with liraglutide 3.0 mg has been associated with gallbladder‐related adverse events. To conduct a single‐centre, double‐blind, 12‐week trial comparing the effect of 0.6 mg liraglutide and steady‐state liraglutide 3.0 mg with placebo on gallbladder emptying in adults with body mass index (BMI) ≥27 kg/m 2 and without diabetes.

          Methods

          Participants were randomized 1:1 to once‐daily subcutaneous liraglutide ( n = 26) or placebo ( n = 26), starting at 0.6 mg with 0.6‐mg weekly increments to 3.0 mg, with nutritional and physical activity counselling. A 600‐kcal (23.7 g fat) liquid meal test was performed at baseline, after the first dose and after 12 weeks. The primary endpoint was the 12‐week maximum postprandial gallbladder ejection fraction (GBEF max), measured over 240 minutes after starting the meal.

          Results

          Baseline characteristics were similar between groups (mean ± SD overall age 47.6 ± 10.0 years, BMI 32.6 ±3.4 kg/m 2, 50% women). Mean 12‐week GBEF max (treatment difference −3.7%, 95% confidence interval [CI] −13.1, 5.7) and area under the GBEF curve in the first 60 minutes (−390% × min, 95% CI −919, 140) did not differ for liraglutide 3.0 mg ( n = 23) vs placebo ( n = 24). The median (range) time to GBEF max was 151 (11‐240) minutes with liraglutide 3.0 mg and 77 (22‐212) minutes with placebo. Similar findings were noted after the first 0.6‐mg liraglutide dose. Gastrointestinal disorders, notably nausea and constipation, were the most frequently reported adverse events.

          Conclusions

          Treatment with liraglutide did not affect the GBEF max but appeared to prolong the time to GBEF max.

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          Most cited references 29

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          World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.

           WMADo Helsinki (corresponding) (2000)
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            3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial

            Liraglutide 3·0 mg was shown to reduce bodyweight and improve glucose metabolism after the 56-week period of this trial, one of four trials in the SCALE programme. In the 3-year assessment of the SCALE Obesity and Prediabetes trial we aimed to evaluate the proportion of individuals with prediabetes who were diagnosed with type 2 diabetes.
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              Epidemiology and risk factors for gallstone disease: has the paradigm changed in the 21st century?

              Gallstone disease is common and costly, creating over 700,000 cholecystectomies annually. Its complications consume approximately $6.5 billion in the United States. Surveys using noninvasive ultrasonography have identified its true prevalence and the associated risk factors. In developed countries, at least 10% of white adults harbor cholesterol gallstones; women have twice the risk, and age further increases the prevalence in both sexes. Gallstones reach epidemic proportions in the North and South American Indian populations, accompanied by an increased risk for gallbladder cancer. In contrast, the rate in sub-Saharan Africa and Asia is quite low. Obesity, a major risk factor, likely relates to insulin resistance (the metabolic syndrome). Evolution and circumstance in American Indians may have ironically selected those with "thrifty" genes that conserve energy. Our abundant access to food places us at the increased risk of obesity and cholelithiasis. The general rise in obesity in many countries raises the specter of heightened disease, best identified by epidemiologic studies.
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                Author and article information

                Contributors
                filipknop@dadlnet.dk
                Journal
                Diabetes Obes Metab
                Diabetes Obes Metab
                10.1111/(ISSN)1463-1326
                DOM
                Diabetes, Obesity & Metabolism
                Blackwell Publishing Ltd (Oxford, UK )
                1462-8902
                1463-1326
                10 July 2018
                November 2018
                : 20
                : 11 ( doiID: 10.1111/dom.2018.20.issue-11 )
                : 2557-2564
                Affiliations
                [ 1 ] Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen Gentofte Hospital Hellerup Denmark
                [ 2 ] Department of Clinical Pharmacology Novo Nordisk A/S Søborg Denmark
                [ 3 ] Department of Medicine and Science Novo Nordisk A/S Søborg Denmark
                [ 4 ] Department of Biostatistics Novo Nordisk A/S Aalborg Denmark
                [ 5 ] Department of Clinical Pharmacology Bispebjerg Hospital, University of Copenhagen Copenhagen Denmark
                [ 6 ] Department of Clinical Medicine, Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark
                [ 7 ] Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark
                Author notes
                [* ] Correspondence

                Filip K. Knop MD, Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen, Gentofte Hospital, Kildegårdsvej 28, 2900 Hellerup, Denmark.

                Email: filipknop@ 123456dadlnet.dk

                Article
                DOM13420
                10.1111/dom.13420
                6220792
                29892986
                © 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                Page count
                Figures: 2, Tables: 2, Pages: 8, Words: 6177
                Product
                Funding
                Funded by: Novo Nordisk A/S, Bagsværd, Denmark
                Categories
                Original Article
                Original Articles
                Custom metadata
                2.0
                dom13420
                November 2018
                Converter:WILEY_ML3GV2_TO_NLMPMC version:version=5.5.1 mode:remove_FC converted:07.11.2018

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