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

Primary Purpose

Exercise Therapy, Metabolic Syndrome X, Cardiorespiratory Fitness

Status

Completed

Phase

Early Phase 1

Locations

Spain

Study Type

Interventional

Intervention

MEDICATION AND EXERCISE TRAINING

About this trial

This is an interventional treatment trial for Exercise Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Castilla-La Mancha (Exercise Physiology Lab)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

PLACEBO FIRST THEN MEDICATED

MEDICATED FIRST THEN PLACEBO

Arm 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.

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.

Outcomes

Primary Outcome Measures

Systolic Blood Pressure

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

Diastolic Blood Pressure

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

Mean Arterial Pressure

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

Secondary Outcome Measures

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.

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.

Body Weight

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

Full Information

NCT ID

NCT03019796

First Posted

December 31, 2016

Last Updated

May 18, 2021

Sponsor

University of Castilla-La Mancha

Collaborators

Ministerio de Economía y Competitividad, Spain

1. Study Identification

Unique Protocol Identification Number

NCT03019796

Brief Title

Exercise Training Effects on Metabolic Syndrome: Interactions With Medication

Acronym

METSYND

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

July 2015 (Actual)

Primary Completion Date

April 2018 (Actual)

Study Completion Date

August 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Castilla-La Mancha

Collaborators

Ministerio de Economía y Competitividad, Spain

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Exercise Therapy, Metabolic Syndrome X, Cardiorespiratory Fitness

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PLACEBO FIRST THEN MEDICATED

Arm Type

Experimental

Arm Description

Arm Title

MEDICATED FIRST THEN PLACEBO

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

MEDICATION AND EXERCISE TRAINING

Intervention Description

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 Outcome Measure Information:

Title

Systolic Blood Pressure

Description

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

Time Frame