OP0011 EFFECT OF LIRAGLUTIDE ON BODY WEIGHT AND PAIN IN THE TREATMENT OF OVERWEIGHT AND KNEE OSTEOARTHRITIS: A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

2019 ◽  
Author(s):  
Henrik Gudbergsen ◽  
Anders Overgaard ◽  
Marius Henriksen ◽  
Eva Ejlersen Wæhrens ◽  
Henning Bliddal ◽  
...  
Keyword(s):  
Body Weight ◽  
Knee Osteoarthritis ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis: protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e024065 ◽  
Author(s):  
Henrik Gudbergsen ◽  
Marius Henriksen ◽  
Eva Ejlersen Wæhrens ◽  
Anders Overgaard ◽  
Henning Bliddal ◽  
...  
Keyword(s):  
Weight Loss ◽  
Body Weight ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Single Centre ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Knee Oa ◽  
Parallel Group ◽  
Pain Subscale

IntroductionWith an increasing prevalence of citizens of older age and with overweight, the health issues related to knee osteoarthritis (OA) will intensify. Weight loss is considered a primary management strategy in patients with concomitant overweight and knee OA. However, there are no widely available and feasible methods to sustain weight loss in patients with overweight and knee OA. The present protocol describes a randomised controlled trial evaluating the efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide in a 3 mg/day dosing in patients with overweight and knee OA.Methods and analysis150 volunteer adult patients with overweight or obesity and knee OA will participate in a randomised, double-blind, placebo-controlled, parallel-group and single-centre trial. The participants will partake in a run-in diet intervention phase (week −8 to 0) including a low calorie diet and dietetic counselling. At week 0, patients will be randomised to either liraglutide 3 mg/day or liraglutide placebo 3 mg/day for 52 weeks as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. The co-primary outcomes are changes in body weight and the Knee Injury and Osteoarthritis Outcome Score pain subscale from week 0 to week 52.Ethics and disseminationThe trial has been approved by the regional ethics committee in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. An external monitoring committee (The Good Clinical Practice Unit at Copenhagen University Hospitals) will oversee the trial. The results will be presented at international scientific meetings and through publications in peer-reviewed journals.Trial registration numbers2015-005163-16,NCT02905864, U1111-1171-4970Based on protocol versionV.6; 30 January 2017, 15:30 hours

scholarly journals Effect of Citrulline and Leucine Intake with Exercises on Body Composition, Physical Activity, and Amino Acid Concentration in Older Women: A Randomized Double-Blind Placebo-Controlled Study

Foods ◽  
2021 ◽  
Vol 10 (12) ◽  
pp. 3117
Author(s):  
Mijin Kim ◽  
Hiroko Isoda ◽  
Tomohiro Okura
Keyword(s):  
Physical Activity ◽  
Body Composition ◽  
Body Weight ◽  
Amino Acid ◽  
Older Women ◽  
Body Mass ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Amino Acid Concentrations

The combined intake of citrulline (CIT) and leucine (LEU) can stimulate protein synthesis. Therefore, this study aimed to investigate the effect of combined intake of CIT and LEU accompanied by exercise for 20 weeks on body composition, physical activity (PA), and amino acid concentrations in older Japanese women with low body mass index (BMI) (16 to 21 kg/m2) using a randomized, double-blind, placebo-controlled design. The supplement was administered twice a day for 20 weeks (Ex (exercise) + CIT·LEU group, n = 10: mainly 0.8 g CIT and 1.6 g LEU; Ex + Placebo group, n = 13: mainly 3.5 g carbohydrate). Additionally, both groups exercised (weight-bearing exercise, square stepping exercise) once a week for 75 min. Body composition, PA, and amino acid concentrations in the plasma were measured. Body weight, BMI, body mass, household PA, total PA, and phenylalanine significantly increased in the Ex + CIT·LEU group (p < 0.05) post intervention. This study suggests that the combined intake of CIT and LEU accompanied by exercise can improve body weight, BMI, body mass, and PA in older women with low BMI, which may prevent sarcopenia and frailty.

scholarly journals A randomized, double-blind, placebo-controlled study of liraglutide 3 mg [LIRA 3mg] on weight, body composition, hormonal and metabolic parameters in women with obesity and polycystic ovary syndrome (PCOS)

2021 ◽  
Author(s):  
Karen Elkind-Hirsch ◽  
Neil Chappell ◽  
Donna Shaler ◽  
John Storment ◽  
Drake Bellanger
Keyword(s):  
Body Composition ◽  
Body Weight ◽  
Polycystic Ovary Syndrome ◽  
Polycystic Ovary ◽  
Controlled Study ◽  
Ovary Syndrome ◽  
Double Blind ◽  
Once Daily ◽  
Double Blind Placebo ◽  
Change In Mean

Abstract BackgroundThe efficacy of lifestyle modifications for established obesity is limited in women with polycystic ovary syndrome (PCOS) and more aggressive interventions are needed. We assessed the efficacy and safety of the GLP-1 analogue liraglutide 3mg (LIRA 3mg) versus placebo (PL) for reduction of body weight and hyperandrogenism in women with obesity and PCOSMethodsThis randomized, double-blind, placebo-controlled study enrolled women from a single-outpatient center diagnosed with PCOS (NIH criteria) with a body-mass index of at least 30 kg/m.2 Participants were randomly allocated (2:1) to treatment with a subcutaneous injection LIRA 3mg or visually matching placebo, once daily for 32 weeks, plus lifestyle intervention. Study visits at baseline, and 32 weeks included weight, blood pressure (BP), waist (WC) measures and body composition evaluated by dual-energy X-ray absorptiometry (DXA). Oral glucose tolerance tests (OGTT) were done to assess glycemia, mean blood glucose (MBG), and compute insulin sensitivity (SI) and secretion (IS) measures. Sex steroids, free androgen index (FAI), complete metabolic profile and lipid profiles were measured in the fasting sample. Co-primary endpoints were change in body weight (BW) and FAI. Safety was assessed in all patients who received at least one dose of study drug. This study was registered with ClinicalTrials.gov NCT03480022FindingsFrom October 2018 to June 2020, 88 patients were screened, of whom 82 were randomly assigned to LIRA 3mg (n = 55) or PL (n = 27). Change in mean BW from baseline to week 32 was − 5.7% (SE 0·.75) with LIRA 3mg vs. -1.4% (1.09) with PL (P < 0.002). At week 32, more patients on LIRA 3 mg than on placebo achieved weight reductions of at least 5% (25[57%] of 44 vs. 5 [22%] of 23; (p < 0·007). LIRA 3mg resulted in significant reduction of FAI, improvements in SI and IS as well as OGTT MBG, and improved body fat by DXA. Gastrointestinal adverse events, which were mostly mild to moderate, were reported in 32 (58.2%) of 55 patients with LIRA 3mg, and 5 (18.5%) of 27 with PL.InterpretationIn obese women with PCOS, LIRA 3mg once daily achieved a superior and clinically meaningful decrease in BW and androgenicity and improved cardiometabolic parameters compared with placebo.

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