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

May 18, 2021 updated by: University of Castilla-La Mancha

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Toledo, Spain, 45071
        • University of Castilla-La Mancha (Exercise Physiology Lab)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PLACEBO FIRST THEN MEDICATED
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

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).
EXPERIMENTAL: MEDICATED FIRST THEN PLACEBO
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

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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).
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.
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.
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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Castilla-La Mancha

Collaborators

Ministerio de Economía y Competitividad, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2015

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ACTUAL)

August 1, 2020

Study Registration Dates

First Submitted

December 31, 2016

First Submitted That Met QC Criteria

January 10, 2017

First Posted (ESTIMATE)

January 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2021

Last Update Submitted That Met QC Criteria

May 18, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0112001154 DEP2014-52930-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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