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Ectopic Adipose Tissue, Exercise Training and IL-6

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Rigshospitalet

Status

Completed

Conditions

Adiposity

Treatments

Drug: Placebo
Behavioral: Endurance Exercise Training
Drug: Tocilizumab
Behavioral: Resistance Exercise Training
Behavioral: No Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT02901496
H-16018062

Details and patient eligibility

About

Aim: Exercise training improves the risk of cardiometabolic diseases; yet the underlying mechanisms are unclear. Exercise induces release of IL-6 from skeletal muscle. Acute elevations in IL-6 improve lipid and glucose metabolism, the latter partly through a delayed gastric emptying. Physical inactivity causes accumulation of visceral fat (VAT). Visceral and epicardial adipose tissue (EAT) is more inflamed than subcutaneous adipose tissue. Thus, the investigators hypothesize that exercise-induced IL-6 mediates the exercise-induced reduction in EAT and VAT. Secondly, the investigators hypothesize that exercise-induced adaptations in glucose metabolism and gastric motility are dependent on IL-6. Finally the investigators hypothesise that both endurance and resistance exercise training reduce VAT and EAT.

Primary aim: To investigate the effects of exercise training on VAT and to determine to what extend IL-6 mediates this effect.

Secondary aims: 1) To determine whether 12 weeks of endurance and strength training can reduce the amount of EAT. 2) To study whether the effects of exercise on glucose metabolism and gastric emptying are dependent on IL-6.

Methods: Inclusion: 70 inactive men and women, >18 years, waist to height ratio > 0.5 and/or waist circumference ≥ 88 cm (women); waist circumference ≥ 102 cm (men) Design: A 12-week, double-blinded randomised, placebo-controlled exercise intervention study.

Intervention: Subjects will be randomised to one of five groups: i) Tocilizumab (IL-6 receptor antibody) and endurance training, ii) Placebo to Tocilizumab and endurance training, iii) Tocilizumab, no exercise iv) Placebo to Tocilizumab and no training, and v) Placebo to Tocilizumab, and resistance training. Tocilizumab/placebo dose will be administered (according to standard recommendations) before the first training session, and maintained during the 12-week training program. Training will be supervised to ensure intensity and compliance. Subjects will be instructed not to change eating habits and informed that this study does not aim for a weight loss.

Statistical considerations: Study investigators are blinded to treatment allocation. Dropouts will be replaced. A sample size of 70 subjects is needed to detect a 10% change in visceral adipose, with a power of 80% and a significance level of 0.05.

Enrollment

83 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Men and women
  • Sedentary
  • Waist to height ratio ≥ ½ and/or waist circumference ≥ 88 cm (women); waist circumference ≥ 102 cm (men)
  • Age ≥ 18 y

Exclusion criteria

  • Pregnancy
  • Diagnosed with diabetes (HbA1c ≥ 48 mmol/mol or fasting glucose ≥ 7.0 mmol/l)
  • Diagnosed with ischemic heart disease
  • Atrial fibrillation
  • Treatment with biologic rheumatic drugs, systemic prednisolone or other immunosuppressive treatments
  • Health conditions that prevents individuals from participating in the exercise training intervention e.g. severe obesity
  • Patients who cannot undergo MRI scans (e.g. kidney disease, metallic implants or claustrophobia)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

83 participants in 5 patient groups, including a placebo group

Endurance exercise + infusion of Tocilizumab
Experimental group
Description:
Endurance exercise training + monthly infusion of Tocilizumab
Treatment:
Drug: Tocilizumab
Behavioral: Endurance Exercise Training
Endurance exercise + infusion of placebo
Experimental group
Description:
Endurance exercise training + monthly infusion of placebo
Treatment:
Behavioral: Endurance Exercise Training
Drug: Placebo
No exercise + infusion of Tocilizumab
Experimental group
Description:
No exercise + monthly infusion of Tocilizumab
Treatment:
Behavioral: No Exercise
Drug: Tocilizumab
No exercise + infusion of placebo
Placebo Comparator group
Description:
No exercise training + monthly infusion of placebo
Treatment:
Behavioral: No Exercise
Drug: Placebo
Resistance exercise + infusion of placebo
Experimental group
Description:
Resistance exercise training + monthly infusion of placebo
Treatment:
Behavioral: Resistance Exercise Training
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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