NCT03019796

Exercise Training Effects on Metabolic Syndrome: Interactions With Medication

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Castilla-La Mancha · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Exercise Therapy
• Metabolic Syndrome X
• Cardiorespiratory Fitness

Interventions

Type	Name	Description
DRUG	MEDICATION AND EXERCISE TRAINING	PARTICIPANTS WILL BE (IN A RANDOMIZED BLINDED FASHION) WITHDRAWN OF THEIR HYPERTENSIVE MEDICATION (I.E., PLACEBO) IN ONE OCCASION AND TESTED WITH THEIR MEDICATION IN ANOTHER, WITH A WEEK WASHOUT PERIOD.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).

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-04-01
• Completion: 2020-08-01
• First posted: 2017-01-13
• Last updated: 2021-06-14
• Results posted: 2021-05-18

Locations

1 site across 1 country: Spain