Angiotensin-Converting-Enzyme Inhibitor, Angiotensin Hypertension, Exercise Training, Fasting, Intermittent, Metabolic Syndrome, Protection Against, Metformin, Statins
Conditions
Keywords
Cardiorespiratory fitness, Insulin sensitivity, Dyslipidemia, Hypertension
Brief summary
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.
Detailed description
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.
Interventions
DRUGEXERCISE TRAINING WITH OR WITHOUT MEDICATION
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.
Sponsors
Ministerio de Economía y Competitividad, Spain
Servicio de Salud de Castilla-La Mancha
University of Castilla-La Mancha
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Habitual medicine will be embedded in bigger capsules along with a placebo to be able to randomly allocate medicine/placebo. The first meal in the morning will be also masked by either providing a non-caloric or caloric vanilla-flavored beverage resulting in the fed/fasted condition in a blinded fashion.
Intervention model description
Cross-over randomized, pretest-posttest control group experimental design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Metabolic syndrome patients diagnosed according to The International diabetes federation consensus of 2009 (Alberti, et al., Circulation).
Exclusion criteria
* Cardiovascular disease or musculo-skeletal that prevents them from being able to perform intense exercise. * Respiratory failure * Liver o renal disease * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin sensitivity assessed using intravenous glucose tolerance test | 12 months | Curves of insulin-mediated glucose clearance, inhibition of lipolysis, and liver glucose output measured with the use of stable isotope infusion. |
| Post-prandial lipemia assessed by an oral fat tolerance test | 12 months | Rates of appearance and clearance of liver VLDL-TG, Apolipoprotein B, and fatty acids using stable isotopes. |
| Blood pressure assessed by ECG-gated automated sphygmomanometer | 12 months | Determined immediately after treatments and during the following 24-h using ambulatory blood pressure Holter-type monitors. |
| Glycemic control assessed by 24-h continuous interstitial glucose monitoring | 36 months | Determined by a patch glucose sensor paired with a glucose monitor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal rate of fat oxidation assessed by indirect calorimetry during a submaximal exercise test. | 12 months | Calculated in grams per min during the incremental cycle ergometer test with the use of indirect calorimetry system |
| Body composition. | 12 months | Determined by bioelectrical impedance to calculate body fat mass and fat free mass. |
| The activity of intramuscular proteins (enzymes) involved in energetics assessed using western blots. | 36 months | Measured in skeletal muscle obtained by percutaneous muscle biopsy. |
| 24-hour monitoring of blood concentrations of metformin, statins, and angiotensin blockers assessed using gas chromatography-mass spectrometry. | 36 months | To study the pharmacokinetics of the habitual medicines used by our subjects during the different experimental conditions |
| Body mass index | 12 months | Determined by body weight (kg) and height (m) to calculate body mass index (kg/m2) |
| Maximal oxygen consumption during a graded exercise test to exhaustion, assessed by indirect calorimetry | 12 months | Calculation of cardiorespitarory fitness |
| Resting metabolic rate assessed by indirect calorimetry while lying after an overnight fast | 12 months | Using indirect calorimetry and a ventilated canopy system |
Countries
Spain
Contacts
Primary ContactRicardo Mora-Rodriguez, PhD
Backup ContactJuan F Ortega, MD, PhD
Outcome results
None listed