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

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

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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.

Original languageEnglish
Article number266
JournalTrials
Volume19
Number of pages11
ISSN1745-6215
DOIs
Publication statusPublished - 2. May 2018

Keywords

  • Epicardial adipose tissue
  • Exercise
  • Gastric emptying rate
  • Glucose homeostasis
  • Interleukin-6
  • Visceral adipose tissue
  • Gastric Emptying/drug effects
  • Obesity, Abdominal/blood
  • Receptors, Interleukin-6/antagonists & inhibitors
  • Interleukin-6/antagonists & inhibitors
  • Humans
  • Middle Aged
  • Male
  • Physical Endurance
  • Resistance Training
  • Waist-Height Ratio
  • Young Adult
  • Time Factors
  • Aged, 80 and over
  • Adult
  • Biomarkers/blood
  • Female
  • Blood Glucose/metabolism
  • Treatment Outcome
  • Randomized Controlled Trials as Topic
  • Waist Circumference
  • Intra-Abdominal Fat/drug effects
  • Antibodies, Monoclonal, Humanized/administration & dosage
  • Adolescent
  • Denmark
  • Aged

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