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Completed

NCT Number: NCT03019796

Exercise Training Effects on Metabolic Syndrome: Interactions With Medication

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Castilla-La Mancha (Exercise Physiology Lab)

Toledo, 45071, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEDICATION AND EXERCISE TRAINING

Drug

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).

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: 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.

    Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.

  2. Diastolic Blood Pressure

    Time frame: 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.

    Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.

  3. Mean Arterial Pressure

    Time frame: 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.

    Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.

Secondary outcomes

  1. Maximal Oxygen Consumption Rate During Exercise (VO2max).

    Time frame: 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.

    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.

  2. Maximal Rate of Fat Oxidation.

    Time frame: 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.

    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.

  3. Body Weight

    Time frame: 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.

    Nude body weight. Value is the difference between the placebo and antihypertensive medication.

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Collaborators

  • Ministerio de Economía y Competitividad, Spain

Registry information

Official study title

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

Acronym: METSYND

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Jan 13, 2017
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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