Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on sleep in brain health

LIVE: Thursday 2nd May 2024, 18:00-19:30 (CEST)

Quality sleep is essential for health. But what happens to our brains when sleep patterns are disturbed? Join our experts to explore the interplay between sleep disruption and neurological diseases, and the questions that you need to be asking your patients to help you prevent the harmful effects of sleep deprivation.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2018

Login to get access

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.
Appendix
Available only for authorised users
Literature
1.
Pedersen BK. The anti-inflammatory effect of exercise: its role in diabetes and cardiovascular disease control. Essays Biochem. 2006;42:105–17.CrossRefPubMed
2.
Noyes AM, Dua K, Devadoss R, et al. Cardiac adipose tissue and its relationship to diabetes mellitus and cardiovascular disease. World J Diabetes. 2014;5:868–76.CrossRefPubMedPubMedCentral
3.
4.
Vissers D, Hens W, Taeymans J, et al. The effect of exercise on visceral adipose tissue in overweight adults: a systematic review and meta-analysis. PLoS One. 2013;8:e56415.CrossRefPubMedPubMedCentral
5.
Ross R, Dagnone D, Jones PJH, et al. Diet-induced weight loss or exercise-induced weight loss in men. Ann Intern Med. 2000;133:92–103.CrossRefPubMed
6.
Holloszy JO. Exercise-induced increase in muscle insulin sensitivity. J Appl Physiol. 2005;99:338–43.CrossRefPubMed
7.
Peterson AM, Pedersen BK. The role of IL-6 in mediating the anti-inflammatory effects of exercise. J Physiol Pharmacol. 2006;57:43–51.
8.
Petersen EW, Carey AL, Sacchetti M, et al. Acute IL-6 treatment increases fatty acid turnover in elderly humans in vivo and in tissue culture in vitro. Am J Physiol Endocrinol Metab. 2005;288:E155–62.CrossRefPubMed
9.
Kim MK. Aerobic exercise training reduces epicardial fat in obese men. J Appl Physiol. 2008;106:5–11.CrossRefPubMed
10.
Ellingsgaard H, Hauselmann I, Schuler B, et al. Interleukin-6 enhances insulin secretion by increasing glucagon-like peptide-1 secretion from L cells and alpha cells. Nat Med. 2011;17:1481–9.CrossRefPubMedPubMedCentral
11.
12.
Holst JJ, Gribble F, Horowitz M, et al. Roles of the gut in glucose homeostasis. Diabetes Care. 2016;39:884–92.CrossRefPubMed
13.
Donges CE, Duffield R, Drinkwater EJ. Effects of resistance or aerobic exercise training on interleukin-6, C-reactive protein, and body composition. Med Sci Sport Exerc. 2010;42:304–13.CrossRef
14.
Olson TP, Dengel DR, Leon AS, et al. Changes in inflammatory biomarkers following one-year of moderate resistance training in overweight women. Int J Obes. 2007;31:996–1003.CrossRef
15.
Osei K, Gaillard T. Disparities in cardiovascular disease and type 2 diabetes risk factors in blacks and whites: dissecting racial paradox of metabolic syndrome. Front Endocrinol (Lausanne). 2017;8:204.CrossRef
16.
Pedersen BK, Febbraio MA. Muscles, exercise and obesity: skeletal muscle as a secretory organ. Nat Rev Endocrinol. 2012;8:457–65.CrossRefPubMed
17.
Pedersen BK. Anti-inflammatory effects of exercise: role in diabetes and cardiovascular disease. Eur J Clin Investig. 2017;47:600–11.CrossRef
18.
19.
Vega GL, Adams-Huet B, Peshock R, et al. Influence of body fat content and distribution on variation in metabolic risk. J Clin Endocrinol Metab. 2006;91:4459–66.CrossRefPubMed
20.
Tremblay MS, Aubert S, Barnes JD, et al. Sedentary Behavior Research Network (SBRN) – Terminology Consensus Project process and outcome. Int J Behav Nutr Phys Act. 2017;14:75.CrossRefPubMedPubMedCentral
21.
Garber CE, Blissmer B, Deschenes MR, et al. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011;43:1334–59.CrossRefPubMed
22.
Sedentary Behaviour Research Network (SBRN). Letter to the editor: Standardized use of the terms ‘sedentary’ and ‘sedentary behaviours’. Ment Health Phys Act. 2013;6:55–6.CrossRef
23.
Wattanapisit A, Thanamee S. Evidence behind 10,000 steps walking. J Health Res. 2017;31:241–8.
24.
25.
Smolen JS, Beaulieu A, Rubbert-Roth A, et al. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet. 2008;371:987–97.CrossRefPubMed
26.
Lancaster J, Ghiatas A, Alyassin A, et al. Measurement of abdominal fat with T1-weighted MR images. J Magn Reson Imaging. 1991;1:363–9.CrossRefPubMed
27.
Positano V, Gastaldelli A, Sironi AM, et al. An accurate and robust method for unsupervised assessment of abdominal fat by MRI. J Magn Reson Imaging. 2004;20:684–9.CrossRefPubMed
28.
Heading R, Nimmo J, Prescott L, et al. The dependence of paracetamol absorption on the rate of gastric emptying. Br J Pharmac. 1973;47:415–21.CrossRef
29.
30.
Ware JH. Interpreting incomplete data in studies of diet and weight loss. N Engl J Med. 2003;348:2136–7.CrossRefPubMed
31.
Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10:28–55.CrossRefPubMed
32.
Christensen R, Bliddal H, Henriksen M. Enhancing the reporting and transparency of rheumatology research: a guide to reporting guidelines. Arthritis Res Ther. 2013;15:109.CrossRefPubMedPubMedCentral
33.
34.
Karstoft K, Winding K, Knudsen SH, et al. The effects of free-living interval-walking training on glycemic control, body composition, and physical fitness in type 2 diabetic patients. Diabetes Care. 2013;36:228–36.CrossRefPubMedPubMedCentral
35.
Lindegaard B, Hansen T, Hvid T, et al. The effect of strength and endurance training on insulin sensitivity and fat distribution in human immunodeficiency virus-infected patients with lipodystrophy. J Clin Endocrinol Metab. 2008;93:3860–9.CrossRefPubMed
36.
Helgerud J, Høydal K, Wang E, et al. Aerobic high-intensity intervals improve V̇O2max more than moderate training. Med Sci Sports Exerc. 2007;39:665–71.CrossRefPubMed
37.
World Medical Association. World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects. JAMA. 2013;310:2191–4.CrossRef
38.
Metadata
Title
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
Authors
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
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2637-0

Other articles of this Issue 1/2018

Trials 1/2018 Go to the issue

Study protocol

Efficacy of acupuncture on pelvic pain in patients with endometriosis: study protocol for a randomized, single-blind, multi-center, placebo-controlled trial

Study protocol

Comparative effectiveness and economic evaluation of Chuna manual therapy for chronic neck pain: protocol for a multicenter randomized controlled trial

Study protocol

Hypertension management for community-dwelling older people with diabetes in Nanchang, China: study protocol for a cluster randomized controlled trial

Study protocol

A couple-based HIV prevention intervention for Latino men who have sex with men: study protocol for a randomized controlled trial

Study protocol

Enhancing maternal and infant wellbeing: study protocol for a feasibility trial of the Baby Triple P Positive Parenting programme for mothers with severe mental health difficulties (the IMAGINE study)

Study protocol

Short-course antimicrobial therapy for paediatric respiratory infections (SAFER): study protocol for a randomized controlled trial