Computational protocol: Efficacy of high-intensity, low-volume interval training compared to continuous aerobic training on insulin resistance, skeletal muscle structure and function in adults with metabolic syndrome: study protocol for a randomized controlled clinical trial (Intraining-MET)

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Protocol publication

[…] The estimation of the proportion of the area occupied by type II muscle fibers will be made at the beginning and the end of the exercise training program in the first week after the last session, based on the quantification of carnosine in the right vastus lateralis muscle (VLM) using the proton magnetic resonance spectroscopy technique (1H–MRS) [] and a flexible coil according to the technique standardized by our group to evaluate body segments of large muscle mass [], in turn modified from Baguet’s technique []. A three-Tesla Magnetom Skyra magnet, with a Flex Large 4A3T coil interface and the SyngoMR D13 program (Siemens, Germany), will be used. Each person will be placed in the supine position on the spectroscopy table, with the lower limbs extended and supported on a 5-cm cushion in the popliteal region. The largest mass of the VLM will be sought in the area between the middle of the externally facing right thigh and the middle third and distal junction of the same thigh; these anatomical points will be indicated with vitamin E capsules. A voxel of 10 × 15 × 35 mm will be positioned in the most voluminous region of the muscle, in the area delimited by the capsules, using a T1-weighted gradient-echo sequence in the three planes, with 5 mm sections and repetition time (RT)/echo time (ET) = 250/2.52 ms. The acquisition of the spectra will be performed using a point-resolved single voxel spectroscopy (PRESS) sequence with and without water saturation to evaluate the carnosine and water signals, respectively. For the processing of the signals and the absolute quantification of carnosine, the jMRUI 5.1 program (Autonomous University of Barcelona, Spain) will be used, with phase correction, Gaussian apodization, adjustment of the water reference to 4.7 ppm and subtraction of water, lipids and other metabolites within the signal. [...] Initially, an exploratory analysis of the data will be carried out, and the Shapiro-Wilk test will be used to evaluate if the quantitative variables come from a population with a normal distribution. The mean and the standard deviation, the median and the interquartile range and the percentage will be used for the description of the socio-demographic, clinical, anthropometric and physiological variables of the included persons.Both intention-to-treat and by-protocol analyses will be carried out; the latter will consider those patients who had adherence higher than 80%. The multiple imputation method (10 imputations) will be used to manage missing data based on age, gender, BMI and baseline VO2 max [].Analysis of covariance (ANCOVA) will be used [] to estimate the effect of HIIT-low volume compared to CAE on IR, IS, percentage of pancreatic β-cell functioning, plasma levels of musclin and apelin and mass and composition of thigh muscle by fiber type at the end of the intervention. The assumptions of homogeneity of variance will be assessed with the Levene F test and the linearity and homogeneity of the slopes. If the assumptions are not met, a logarithmic transformation will be performed, or the Box-Cox procedure will be used. The variables used in the minimization procedure (age, gender and BMI) will be included in the analysis according to the current recommendations []. A re-randomization test will be performed using permutations for inference purposes [].To establish if the musclin, apelin, muscle mass and fiber type composition of the thigh mediate the effect of training on IR, a theoretical model was proposed to estimate the total, direct and indirect effects and the percentage explained by the mediator (Fig. ). A model of structural equations will be used with the “path analysis” technique and basic principles proposed in the context of clinical trials [–]. A statistical significance level œ = 0.05 will be established, and STATA, version 14.0, and IBM SPSS Statistics, version 21.0, will be used.Fig. 3 […]

Pipeline specifications

Software tools jMRUI, SPSS
Applications Miscellaneous, NMR-based metabolomics
Organisms Homo sapiens, Dipturus trachyderma
Diseases Metabolic Diseases
Chemicals Carnosine, Oxygen