The role of exercise combined with tocilizumab in visceral and epicardial adipose tissue and gastric emptying rate in abdominally obese participants: protocol for a randomised controlled trial
Regitse Højgaard Christensen,
Anne-Sophie Wedell-Neergaard,
Louise Lang Lehrskov,
Grit Elster Legård,
Emma Berndt Dorph,
Stine Nymand,
Maria Korf Ball,
Morten Zacho,
Robin Christensen,
Helga Ellingsgaard,
Jaya Birgitte Rosenmeier,
Rikke Krogh-Madsen,
Bente Klarlund Pedersen,
Kristian Karstoft
Affiliations
Regitse Højgaard Christensen
The Centre of Inflammation and Metabolism (CIM) and The Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen
Anne-Sophie Wedell-Neergaard
The Centre of Inflammation and Metabolism (CIM) and The Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen
Louise Lang Lehrskov
The Centre of Inflammation and Metabolism (CIM) and The Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen
Grit Elster Legård
The Centre of Inflammation and Metabolism (CIM) and The Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen
Emma Berndt Dorph
The Centre of Inflammation and Metabolism (CIM) and The Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen
Stine Nymand
The Centre of Inflammation and Metabolism (CIM) and The Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen
Maria Korf Ball
The Centre of Inflammation and Metabolism (CIM) and The Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen
Morten Zacho
The Centre of Inflammation and Metabolism (CIM) and The Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen
Robin Christensen
Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital
Helga Ellingsgaard
The Centre of Inflammation and Metabolism (CIM) and The Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen
Jaya Birgitte Rosenmeier
Department of Cardiology, Copenhagen University Hospital Bispebjerg, Capital Region of Copenhagen
Rikke Krogh-Madsen
The Centre of Inflammation and Metabolism (CIM) and The Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen
Bente Klarlund Pedersen
The Centre of Inflammation and Metabolism (CIM) and The Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen
Kristian Karstoft
The Centre of Inflammation and Metabolism (CIM) and The Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen
Abstract Background Exercise reduces the amount of visceral adipose tissue (VAT) and the risk of cardiometabolic diseases. The underlying mechanisms responsible for these exercise-induced adaptations are unclear, but they may involve lipolytic actions of interleukin-6 (IL-6). Contracting skeletal muscles secrete IL-6, leading to increased circulating IL-6 levels in response to exercise. The aim of this study is to investigate whether IL-6 is involved in mediating the effects of exercise on visceral and epicardial adipose tissue volume and glycaemic control. Methods/design Seventy-five physically inactive males and females aged > 18 years with a waist-to-height ratio > 0.5 and/or waist circumference ≥ 88 cm (females) or ≥ 102 cm (males) are being recruited to participate in a 12-week intervention study. Participants are randomly allocated to one of five groups (1:1:1:1:1). Two groups consist of supervised endurance exercise training combined with the IL-6 blocker tocilizumab (ET) or saline used as placebo (EP), two groups consist of no exercise combined with tocilizumab (NT) or placebo (NP), and one group consists of resistance exercise and placebo (RP). Although the study is an exploratory trial, the primary outcome is change in VAT volume from before to after intervention, with secondary outcomes being changes in (1) epicardial adipose tissue, (2) pericardial adipose tissue and (3) gastric emptying. Depots of adipose tissue are quantitated by magnetic resonance imaging Gastric emptying and glucose metabolism are assessed using mixed-meal tolerance tests. Discussion Understanding the role of IL-6 in mediating the effects of exercise on visceral and epicardial adipose tissue and glycaemic control may lead to novel therapeutic approaches in the prevention of cardiometabolic diseases. Trial registration ClinicalTrials.gov, NCT02901496. Registered on 1 August 2016 and posted retrospectively on 15 September 2016.
