Exercise Training Effects on Metabolic Syndrome: Interactions With Medication (METSYND)
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|ClinicalTrials.gov Identifier: NCT03019796|
Recruitment Status : Recruiting
First Posted : January 13, 2017
Last Update Posted : May 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Exercise Therapy Metabolic Syndrome X Cardiorespiratory Fitness||Behavioral: EXERCISE TRAINING Behavioral: NO EXERCISE TRAINING||Not Applicable|
Objective: The purpose is to study in a group of adults with metabolic syndrome and obesity, the effects of different modalities of exercise training on cardiorespiratory and metabolic fitness. The main objective is to weight the effects of exercise training separately and in conjunction with the subject's habitual pharmacological treatment to identify the best combination of drug and exercise.
Methods and design: Randomized, pretest-posttest control group experimental design. Project developed in a single center with the collaboration of the regional public health system.
Subjects: Will be referred by their primary care physicians to our study unit. Up to 160 subjects all of them with metabolic syndrome will be recruited (20% women).
- Specifically, the investigators, will study cardiovascular adaptations that increase, i) maximal aerobic capacity measured by VO2max, ii) anaerobic and respiratory compensation point ventilatory thresholds, iii) cardiac function measured by assessing cardiac output and stroke volume using the re-breathing technique, iv) arterial stiffness, measured by pulse wave velocity and augmentation index using applanation tonometry (SphygmoCor System), v) central and peripheral blood pressure, and vi) biological markers of endothelial dysfunction using reactive hyperemia with a laser Doppler fluxmeter in central and peripheral blood vessels.
- The metabolic adaptations under study will include, i) insulin resistance measured by IVGTT, ii) fat oxidation by indirect calorimetry, iii) intramuscular proteins involved in energetics by percutaneous muscle biopsy and western blots, iv) mitochondria biogenesis by activity of citrate synthase and v) stable-isotopic study of glucose and free fatty acids kinetics in blood (using gas-chromatography mass-spectrometry analysis).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Exercise Training as a Non-pharmacological Treatment for Metabolic Syndrome and Its Interactions With Subjects Habitual Medications.|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||August 2018|
Placebo Comparator: NO EXERCISE TRAINING
The participants of this arm will remain physically inactive (i.e., less than 1 day a week of exercise) during the 4 months of intervention.
The investigators will withhold their medication during 48 h to achieve 2 conditions:
Behavioral: NO EXERCISE TRAINING
REMAINING INACTIVE AND ITS INTERACTIONS WITH METABOLIC SYNDROME PARTICIPANT'S HABITUAL MEDICATION (i.e., blood pressure, glucose, cholesterol and triglycerides lowering drugs).
Experimental: EXERCISE TRAINING
The participants of this arm will exercise during 4 months (i.e., 3 days a week during 45-60 min) at workloads individualized by percent heart rate of either continuous or intervallic aerobic exercise, with increases in workload as exercise adaptations manifest during training.
The investigators will withhold their habitual medication during 48 h to achieve the following 2 conditions:
c) yes exercise, no medication d) yes exercise, yes medication.
Behavioral: EXERCISE TRAINING
EXERCISE TRAINING AND ITS INTERACTIONS WITH METABOLIC SYNDROME PARTICIPANT'S HABITUAL MEDICATION (i.e., blood pressure, glucose, cholesterol and triglycerides lowering drugs).
- Brachial artery systolic and diastolic pressures. [ Time Frame: 6 months ]Determined by using a ECG-gated automated sphygmomanometer (Tango, Suntec Medical, NC., US).
- Waist perimeter. [ Time Frame: 6 months ]Using calibrated measurement tape at the iliac crest level.
- Fasting blood level of glucose, cholesterol HDL, triglycerides, glycosylated hemoglobin and protein C reactive. [ Time Frame: 6 months ]Blood lipid profile to detect metabolic syndrome (Alberti et al., Circulation, 2009)
- Maximal oxygen consumption rate during exercise (VO2max). [ Time Frame: 6 months ]Index of cardiorespiratory fitness assessed during an incremental cycle-ergometer test using an indirect calorimetry system (AEI, Moxus system, US).
- Anaerobic threshold (AT) and respiratory compensation point (RCP). [ Time Frame: 6 months ]Determined by changes in ratios between pulmonary ventilation rates and oxygen and carbon dioxide production during the incremental cycle-ergometer test (Wasserman et al., 2005).
- Maximal rate of fat oxidation. [ Time Frame: 6 months ]Calculated in grams per min during the incremental cycloergometer test wih the use of indirect calorimetry system (AIE, Moxus system, US).
- Arterial stiffness by pulse wave velocity (PWV) and augmentation index (AI). [ Time Frame: 6 months ]Determined by applanation tonometry in the radial and femoral arteries (SphygmoCor; AtCor Medical; Sydney, Australia).
- Peripheral post-occlusion reactive hyperemia. [ Time Frame: 6 months ]Index of endothelial function assessed by measuring forearm peak flow after occlusion using a laser Doppler fluxmeter probe (DRT4; Moor Instruments, Axminster, UK).
- Insulin sensitivity using intravenous glucose tolerance test (IVGTT). [ Time Frame: 6 months ]Infusion of a glucose bolus and blood sampling for the analysis of glucose and insulin following the procedures described by Tura et al., (Diabetologia, 2010)
- Body fat. [ Time Frame: 6 months ]Determined by dual-energy X-ray absorptiometry (Hologic Serie Discovery Wi QDR, Bedford, US).
- Rates of appearance, dissapearance of glycerol and palmitate in blood. [ Time Frame: 6 months ]Infusion of stable isotope of 13C palmitate and measurement of enrichment in blood of 12/13C palmitate using gas chromatography-mass spectrometry (Hewlett Packard 5971).
- Rates of oxidation of plasma and intracellular free fatty acids. [ Time Frame: 6 months ]Analysis of enrichment of 13CO2 collected in expired air using isotope ratio-mass spectrometry (IRMS).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019796
|University of Castilla-La Mancha (Exercise Physiology Lab)||Recruiting|
|Toledo, Spain, 45071|
|Contact: Ricardo Mora-Rodriguez, PhD 92526800 ext 5515 email@example.com|
|Contact: Juan F Ortega, MD, PhD +3492526800 ext 5515 firstname.lastname@example.org|
|Sub-Investigator: Juan F Ortega, MD, PhD|
|Principal Investigator: Ricardo Mora-Rodriguez, PhD|
|Principal Investigator:||Ricardo Mora-Rodriguez, PhD||University of Castilla-La Mancha|