Exercise Training Effects on Metabolic Syndrome: Interactions With Medication

Metabolic Syndrome X Clinical Trial

— METSYND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019796
• Other study ID #: 0112001154 DEP2014-52930-R
• Status: Completed
• Phase: Early Phase 1
• Start date: July 2015
• Est. completion date: August 2020

Study information

• Verified date: May 2021
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2020
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiorespiratory Fitness
• Exercise Therapy
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

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).

Locations

Country	Name	City	State
Spain	University of Castilla-La Mancha (Exercise Physiology Lab)	Toledo

Sponsors (2)

Lead Sponsor	Collaborator
University of Castilla-La Mancha	Ministerio de Economía y Competitividad, Spain

Country where clinical trial is conducted

Spain, 

References & Publications (10)

Díez-Fernández A, Sánchez-López M, Mora-Rodríguez R, Notario-Pacheco B, Torrijos-Niño C, Martínez-Vizcaíno V. Obesity as a mediator of the influence of cardiorespiratory fitness on cardiometabolic risk: a mediation analysis. Diabetes Care. 2014;37(3):855-62. doi: 10.2337/dc13-0416. Epub 2013 Nov 6. — View Citation

Martínez-Vizcaíno V, Sánchez-López M, Notario-Pacheco B, Salcedo-Aguilar F, Solera-Martínez M, Franquelo-Morales P, López-Martínez S, García-Prieto JC, Arias-Palencia N, Torrijos-Niño C, Mora-Rodríguez R, Rodríguez-Artalejo F. Gender differences on effectiveness of a school-based physical activity intervention for reducing cardiometabolic risk: a cluster randomized trial. Int J Behav Nutr Phys Act. 2014 Dec 10;11:154. doi: 10.1186/s12966-014-0154-4. — View Citation

Mora-Rodriguez R, Ortega JF, Guio de Prada V, Fernández-Elías VE, Hamouti N, Morales-Palomo F, Martinez-Vizcaino V, Nelson RK. Effects of Simultaneous or Sequential Weight Loss Diet and Aerobic Interval Training on Metabolic Syndrome. Int J Sports Med. 2016 Apr;37(4):274-81. doi: 10.1055/s-0035-1564259. Epub 2015 Dec 14. — View Citation

Mora-Rodriguez R, Ortega JF, Hamouti N, Fernandez-Elias VE, Cañete Garcia-Prieto J, Guadalupe-Grau A, Saborido A, Martin-Garcia M, Guio de Prada V, Ara I, Martinez-Vizcaino V. Time-course effects of aerobic interval training and detraining in patients with metabolic syndrome. Nutr Metab Cardiovasc Dis. 2014 Jul;24(7):792-8. doi: 10.1016/j.numecd.2014.01.011. Epub 2014 Jan 29. — View Citation

Morales-Palomo F, Ramirez-Jimenez M, Ortega JF, Pallares JG, Mora-Rodriguez R. Cardiovascular Drift during Training for Fitness in Patients with Metabolic Syndrome. Med Sci Sports Exerc. 2017 Mar;49(3):518-526. doi: 10.1249/MSS.0000000000001139. — View Citation

Ortega JF, Fernández-Elías VE, Hamouti N, Pallarés JG, Mora-Rodriguez R. Higher insulin-sensitizing response after sprint interval compared to continuous exercise. Int J Sports Med. 2015 Mar;36(3):209-14. doi: 10.1055/s-0034-1389942. Epub 2014 Nov 6. — View Citation

Ortega JF, Fernández-Elías VE, Hamouti N, Pallares JG, Mora-Rodriguez R. Higher Insulin-sensitizing Response after Sprint Interval Compared to Continuous Exercise. Int J Sports Med. 2015 Mar;36(3):e4. doi: 10.1055/s-0035-1548800. Epub 2015 Mar 26. — View Citation

Ortega JF, Hamouti N, Fernández-Elías VE, de Prada MV, Martínez-Vizcaíno V, Mora-Rodríguez R. Metformin does not attenuate the acute insulin-sensitizing effect of a single bout of exercise in individuals with insulin resistance. Acta Diabetol. 2014 Oct;51(5):749-55. doi: 10.1007/s00592-014-0580-4. Epub 2014 Mar 29. — View Citation

Ortega JF, Hamouti N, Fernández-Elías VE, Mora-Rodriguez R. Comparison of glucose tolerance tests to detect the insulin sensitizing effects of a bout of continuous exercise. Appl Physiol Nutr Metab. 2014 Jul;39(7):787-92. doi: 10.1139/apnm-2013-0507. Epub 2014 Apr 11. — View Citation

Ortega JF, Morales-Palomo F, Fernandez-Elias V, Hamouti N, Bernardo FJ, Martin-Doimeadios RC, Nelson RK, Horowitz JF, Mora-Rodriguez R. Dietary supplementation with omega-3 fatty acids and oleate enhances exercise training effects in patients with metabolic syndrome. Obesity (Silver Spring). 2016 Aug;24(8):1704-11. doi: 10.1002/oby.21552. Epub 2016 Jun 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure	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.
Primary	Diastolic Blood Pressure	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.
Primary	Mean Arterial Pressure	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	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.	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	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.	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	Body Weight	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.