Exercise Training Effects on Metabolic Syndrome: Interactions With Medication (METSYND)

University of Castilla-La Mancha

Status and phase: Completed; Early Phase 1

Conditions: Exercise Therapy; Metabolic Syndrome X; Cardiorespiratory Fitness

Treatments: Drug: MEDICATION AND EXERCISE TRAINING

Study type: Interventional

Funder types: Other

Identifiers

NCT03019796

0112001154 DEP2014-52930-R

Details and patient eligibility

About

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.

Full description

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:

1. 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.
2. The metabolic adaptations under study will include, i) insulin sensitivity by HOMA-IR, ii) fat oxidation by indirect calorimetry

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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40 participants in 2 patient groups

PLACEBO FIRST THEN MEDICATED

Experimental group

Description:

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.

Treatment:

Drug: MEDICATION AND EXERCISE TRAINING

MEDICATED FIRST THEN PLACEBO

Experimental group

Description:

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.

Treatment:

Drug: MEDICATION AND EXERCISE TRAINING