Clinical trial NCT03019796: Exercise Training Effects on Metabolic Syndrome: Interactions With Medication
Official title: Effects of Exercise Training as a Non-pharmacological Treatment for Metabolic Syndrome and Its Interactions With Subjects Habitual Medications.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Exercise Therapy
Metabolic Syndrome X
Cardiorespiratory Fitness
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2017-01-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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:

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

Eligibility criteria: 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

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 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.
measure: Diastolic Blood Pressure
timeFrame: 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.
measure: Mean Arterial Pressure
timeFrame: 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 outcomes:
measure: Maximal Oxygen Consumption Rate During Exercise (VO2max).
timeFrame: 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.
measure: Maximal Rate of Fat Oxidation.
timeFrame: 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.
measure: Body Weight
timeFrame: 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.
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: University of Castilla-La Mancha (Exercise Physiology Lab)
Study officials:
affiliation: University of Castilla-La Mancha
name: Ricardo Mora-Rodriguez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Mora-Rodriguez R, Ortega JF, Guio de Prada V, Fernandez-Elias 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.
citation: Ortega JF, Fernandez-Elias 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. No abstract available.
citation: Martinez-Vizcaino V, Sanchez-Lopez M, Notario-Pacheco B, Salcedo-Aguilar F, Solera-Martinez M, Franquelo-Morales P, Lopez-Martinez S, Garcia-Prieto JC, Arias-Palencia N, Torrijos-Nino C, Mora-Rodriguez R, Rodriguez-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.
citation: Ortega JF, Fernandez-Elias 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):209-14. doi: 10.1055/s-0034-1389942. Epub 2014 Nov 6.
citation: Ortega JF, Hamouti N, Fernandez-Elias 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.
citation: Ortega JF, Hamouti N, Fernandez-Elias VE, de Prada MV, Martinez-Vizcaino V, Mora-Rodriguez 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.
citation: Mora-Rodriguez R, Ortega JF, Hamouti N, Fernandez-Elias VE, Canete 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.
citation: Diez-Fernandez A, Sanchez-Lopez M, Mora-Rodriguez R, Notario-Pacheco B, Torrijos-Nino C, Martinez-Vizcaino 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.
citation: Moreno-Cabanas A, Morales-Palomo F, Alvarez-Jimenez L, Ortega JF, Mora-Rodriguez R. Effects of chronic metformin treatment on training adaptations in men and women with hyperglycemia: A prospective study. Obesity (Silver Spring). 2022 Jun;30(6):1219-1230. doi: 10.1002/oby.23410. Epub 2022 May 17.
citation: Ramirez-Jimenez M, Morales-Palomo F, Moreno-Cabanas A, Alvarez-Jimenez L, Ortega JF, Mora-Rodriguez R. Aerobic exercise training improves nocturnal blood pressure dipping in medicated hypertensive individuals. Blood Press Monit. 2022 Aug 1;27(4):272-275. doi: 10.1097/MBP.0000000000000598. Epub 2022 Apr 18.
citation: Moreno-Cabanas A, Ortega JF, Morales-Palomo F, Ramirez-Jimenez M, Alvarez-Jimenez L, Mora-Rodriguez R. One Bout of Resistance Training Does Not Enhance Metformin Actions in Prediabetic and Diabetic Individuals. Med Sci Sports Exerc. 2022 Jul 1;54(7):1043-1050. doi: 10.1249/MSS.0000000000002889. Epub 2022 Feb 10.
citation: Mora-Rodriguez R, Ortega JF, Morales-Palomo F, Ramirez-Jimenez M, Moreno-Cabanas A, Alvarez-Jimenez L. Endurance Exercise Training reduces Blood Pressure according to the Wilder's Principle. Int J Sports Med. 2022 Apr;43(4):336-343. doi: 10.1055/a-1548-6985. Epub 2021 Sep 24.
citation: Morales-Palomo F, Moreno-Cabanas A, Ramirez-Jimenez M, Alvarez-Jimenez L, Valenzuela PL, Lucia A, Ortega JF, Mora-Rodriguez R. Exercise Reduces Medication for Metabolic Syndrome Management: A 5-Year Follow-up Study. Med Sci Sports Exerc. 2021 Jul 1;53(7):1319-1325. doi: 10.1249/MSS.0000000000002591.
citation: Alvarez-Jimenez L, Moreno-Cabanas A, Ramirez-Jimenez M, Morales-Palomo F, Ortega JF, Mora-Rodriguez R. Effects of statins and exercise on postprandial lipoproteins in metabolic syndrome vs metabolically healthy individuals. Br J Clin Pharmacol. 2021 Mar;87(3):955-964. doi: 10.1111/bcp.14447. Epub 2020 Jul 12.
citation: Morales-Palomo F, Ramirez-Jimenez M, Ortega JF, Moreno-Cabanas A, Mora-Rodriguez R. Exercise Training Adaptations in Metabolic Syndrome Individuals on Chronic Statin Treatment. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgz304. doi: 10.1210/clinem/dgz304.
citation: Guio de Prada V, Ortega JF, Morales-Palomo F, Ramirez-Jimenez M, Moreno-Cabanas A, Mora-Rodriguez R. Women with metabolic syndrome show similar health benefits from high-intensity interval training than men. PLoS One. 2019 Dec 10;14(12):e0225893. doi: 10.1371/journal.pone.0225893. eCollection 2019.
citation: Morales-Palomo F, Ramirez-Jimenez M, Ortega JF, Mora-Rodriguez R. Effectiveness of Aerobic Exercise Programs for Health Promotion in Metabolic Syndrome. Med Sci Sports Exerc. 2019 Sep;51(9):1876-1883. doi: 10.1249/MSS.0000000000001983.
citation: Mora-Rodriguez R, Ortega JF, Ramirez-Jimenez M, Moreno-Cabanas A, Morales-Palomo F. Insulin sensitivity improvement with exercise training is mediated by body weight loss in subjects with metabolic syndrome. Diabetes Metab. 2020 Jun;46(3):210-218. doi: 10.1016/j.diabet.2019.05.004. Epub 2019 May 31.
citation: Mora-Rodriguez R, Ortega JF, Morales-Palomo F, Ramirez-Jimenez M. Weight loss but not gains in cardiorespiratory fitness after exercise-training predicts improved health risk factors in metabolic syndrome. Nutr Metab Cardiovasc Dis. 2018 Dec;28(12):1267-1274. doi: 10.1016/j.numecd.2018.08.004. Epub 2018 Aug 23.
citation: Morales-Palomo F, Ramirez-Jimenez M, Ortega JF, Mora-Rodriguez R. Exercise Periodization over the Year Improves Metabolic Syndrome and Medication Use. Med Sci Sports Exerc. 2018 Oct;50(10):1983-1991. doi: 10.1249/MSS.0000000000001659.
citation: Mora-Rodriguez R, Ramirez-Jimenez M, Fernandez-Elias VE, Guio de Prada MV, Morales-Palomo F, Pallares JG, Nelson RK, Ortega JF. Effects of aerobic interval training on arterial stiffness and microvascular function in patients with metabolic syndrome. J Clin Hypertens (Greenwich). 2018 Jan;20(1):11-18. doi: 10.1111/jch.13130. Epub 2017 Nov 6.
citation: Mora-Rodriguez R, Fernandez-Elias VE, Morales-Palomo F, Pallares JG, Ramirez-Jimenez M, Ortega JF. Aerobic interval training reduces vascular resistances during submaximal exercise in obese metabolic syndrome individuals. Eur J Appl Physiol. 2017 Oct;117(10):2065-2073. doi: 10.1007/s00421-017-3697-7. Epub 2017 Aug 12.
citation: Morales-Palomo F, Ramirez-Jimenez M, Ortega JF, Lopez-Galindo PL, Fernandez-Martin J, Mora-Rodriguez R. Effects of repeated yearly exposure to exercise-training on blood pressure and metabolic syndrome evolution. J Hypertens. 2017 Oct;35(10):1992-1999. doi: 10.1097/HJH.0000000000001430.