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

TY - JOUR

T1 - The role of exercise combined with tocilizumab in visceral and epicardial adipose tissue and gastric emptying rate in abdominally obese participants

T2 - protocol for a randomised controlled trial

AU - Christensen, Regitse Højgaard

AU - Wedell-Neergaard, Anne-Sophie

AU - Lehrskov, Louise Lang

AU - Legård, Grit Elster

AU - Dorph, Emma Berndt

AU - Nymand, Stine

AU - Ball, Maria Korf

AU - Zacho, Morten

AU - Christensen, Robin

AU - Ellingsgaard, Helga

AU - Rosenmeier, Jaya Birgitte

AU - Krogh-Madsen, Rikke

AU - Pedersen, Bente Klarlund

AU - Karstoft, Kristian

PY - 2018/5/2

Y1 - 2018/5/2

N2 - 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.

AB - 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.

KW - Adolescent

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Antibodies, Monoclonal, Humanized/administration & dosage

KW - Biomarkers/blood

KW - Blood Glucose/metabolism

KW - Denmark

KW - Female

KW - Gastric Emptying/drug effects

KW - Humans

KW - Interleukin-6/antagonists & inhibitors

KW - Intra-Abdominal Fat/drug effects

KW - Male

KW - Middle Aged

KW - Obesity, Abdominal/blood

KW - Physical Endurance

KW - Randomized Controlled Trials as Topic

KW - Receptors, Interleukin-6/antagonists & inhibitors

KW - Resistance Training

KW - Time Factors

KW - Treatment Outcome

KW - Waist Circumference

KW - Waist-Height Ratio

KW - Young Adult

U2 - 10.1186/s13063-018-2637-0

DO - 10.1186/s13063-018-2637-0

M3 - Journal article

C2 - 29720225

SN - 1745-6215

VL - 19

JO - Trials

JF - Trials

M1 - 266

ER -