To analyze the effects of altering the time of ingestion of participants' habitual medication (i.e., metformin, statins, ARAII/IACE) and meals around the time of exercise training (exercise fasted or fed) on the improvement of metabolic syndrome factors (hypertension, insulin sensitivity, dyslipidemia, and obesity). There will be a preliminary study of the effects of training "time-of-day" on the primary study outcomes.
Objective: The purpose is to study in a group of adults with metabolic syndrome and obesity, the effects of altering timing between exercise training, meals, and their habitual medication on the improvement in the factors that compose the metabolic syndrome (i.e., hypertension, insulin resistance, central obesity, and dyslipidemia). The main objective is to find the most productive combination between exercise training and the timing of their habitual pharmacological treatment, and meal ingestion for lowering those factors. Methods and design: Cross-over randomized double-blinded, pretest-posttest control group experimental design. The project will be developed in a single center with the collaboration of the regional public health system (SECAM). There will be a preliminary study of the effects of training "time-of-day" on three parallel groups of individuals. Subjects: Will be referred by their primary care physicians to our study unit or recruited by advertisements in local media. Up to 180 subjects, all of them with metabolic syndrome will be recruited (\>25% women). Measurements: Specifically, we will study if the cardiovascular and metabolic adaptations to aerobic training that result in amelioration of metabolic syndrome factors are potentiated by correct timming of training, meals, and medicine around exercise training time.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
A group will train 30 min after taking their habitual dose of medicine (MEDICATED train) while another group will train after taking a placebo (NON-MEDICATED train) and will receive their medication after training.
University of Castilla-La Mancha (Exercise Physiology Lab)
Toledo, Spain
RECRUITINGInsulin sensitivity assessed using intravenous glucose tolerance test
Curves of insulin-mediated glucose clearance, inhibition of lipolysis, and liver glucose output measured with the use of stable isotope infusion.
Time frame: 12 months
Post-prandial lipemia assessed by an oral fat tolerance test
Rates of appearance and clearance of liver VLDL-TG, Apolipoprotein B, and fatty acids using stable isotopes.
Time frame: 12 months
Blood pressure assessed by ECG-gated automated sphygmomanometer
Determined immediately after treatments and during the following 24-h using ambulatory blood pressure Holter-type monitors.
Time frame: 12 months
Glycemic control assessed by 24-h continuous interstitial glucose monitoring
Determined by a patch glucose sensor paired with a glucose monitor.
Time frame: 36 months
Body composition.
Determined by bioelectrical impedance to calculate body fat mass and fat free mass.
Time frame: 12 months
Body mass index
Determined by body weight (kg) and height (m) to calculate body mass index (kg/m2)
Time frame: 12 months
Maximal oxygen consumption during a graded exercise test to exhaustion, assessed by indirect calorimetry
Calculation of cardiorespitarory fitness
Time frame: 12 months
Resting metabolic rate assessed by indirect calorimetry while lying after an overnight fast
Using indirect calorimetry and a ventilated canopy system
Time frame: 12 months
Maximal rate of fat oxidation assessed by indirect calorimetry during a submaximal exercise test.
Calculated in grams per min during the incremental cycle ergometer test with the use of indirect calorimetry system
Time frame: 12 months
24-hour monitoring of blood concentrations of metformin, statins, and angiotensin blockers assessed using gas chromatography-mass spectrometry.
To study the pharmacokinetics of the habitual medicines used by our subjects during the different experimental conditions
Time frame: 36 months
The activity of intramuscular proteins (enzymes) involved in energetics assessed using western blots.
Measured in skeletal muscle obtained by percutaneous muscle biopsy.
Time frame: 36 months
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