Exercise Training Effects on Metabolic Syndrome: Interactions With Medication

Study Overview
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Brief Summary
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To analyze the effects of different exercise training modalities (continuous, intervallic, and resistance training) on cardiorespiratory and metabolic fitness of metabolic syndrome patients when this training interacts with their habitual medication.

Detailed Description
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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 40 subjects all of them with metabolic syndrome will be recruited (at least 20% women). Measurements: 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) arterial stiffness, measured by pulse wave velocity (SphygmoCor System), v) central and peripheral blood pressure, and iv) 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 sensitivity by HOMA-IR, ii) fat oxidation by indirect calorimetry

Official Title
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Effects of Exercise Training as a Non-pharmacological Treatment for Metabolic Syndrome and Its Interactions With Subjects Habitual Medications.

Conditions
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Exercise Therapy, Metabolic Syndrome X, Cardiorespiratory Fitness

Intervention / Treatment
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* Drug: MEDICATION AND EXERCISE TRAINING


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metabolic syndrome patients diagnosed according to the International diabetes federation consensus of 2009 (Alberti, et al., Circulation). 18-65 years old Exclusion Criteria: Cardiovascular disease or musculo-skeletal that prevents them from being able to perform intense exercise. Respiratory failure Patient ends Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PLACEBO FIRST THEN MEDICATED<br>Subjects first receive the PLACEBO tablet during 72 hours (full withdrawal). After a week of taking again their medication (MEDICATION TRIAL), they will be tested again. This procedure will be repeated before and after 4 months of aerobic training. | Drug: MEDICATION AND EXERCISE TRAINING<br>* PARTICIPANTS WILL BE (IN A RANDOMIZED BLINDED FASHION) WITHDRAWN OF THEIR HYPERTENSIVE MEDICATION (I.E., PLACEBO) IN ONE OCCASION AND TESTED WITH THEIR MEDICATION IN ANOTHER, WITH A WEEK WASHOUT PERIOD. THIS TESTING WILL BE REPEATED AFER 4 MONTHS OF EXERCISE TRAINING (48 SESSIONS OF 43 MIN EACH ONE).<br>|
| Experimental: MEDICATED FIRST THEN PLACEBO<br>Subjects first receive their antihypertensive MEDICATION tablet (habitual dose prescribed by their primary care doctors). After a week they will take a PLACEBO tablet for 72 hours and will be tested again. This procedure will be repeated before and after 4 months of aerobic training. | Drug: MEDICATION AND EXERCISE TRAINING<br>* PARTICIPANTS WILL BE (IN A RANDOMIZED BLINDED FASHION) WITHDRAWN OF THEIR HYPERTENSIVE MEDICATION (I.E., PLACEBO) IN ONE OCCASION AND TESTED WITH THEIR MEDICATION IN ANOTHER, WITH A WEEK WASHOUT PERIOD. THIS TESTING WILL BE REPEATED AFER 4 MONTHS OF EXERCISE TRAINING (48 SESSIONS OF 43 MIN EACH ONE).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure | Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication. | Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours. | 
| Diastolic Blood Pressure | Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication. | Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours. | 
| Mean Arterial Pressure | Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication. | Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Oxygen Consumption Rate During Exercise (VO2max). | Index of cardiorespiratory fitness assessed during an incremental cycle-ergometer test using an indirect calorimetry system. Value is the difference between the placebo and antihypertensive medication. | Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours. | 
| Maximal Rate of Fat Oxidation. | Calculated in grams per min during the incremental cycloergometer test wih the use of indirect calorimetry system. Value is the difference between the placebo and antihypertensive medication. | Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours. | 
| Body Weight | Nude body weight. Value is the difference between the placebo and antihypertensive medication. | Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours. |