<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04477590</url>
  </required_header>
  <id_info>
    <org_study_id>DEP2017-83244-R</org_study_id>
    <nct_id>NCT04477590</nct_id>
  </id_info>
  <brief_title>Interactions of Medicine and Exercise With Meal Timing</brief_title>
  <acronym>MMET</acronym>
  <official_title>Optimizing Exercise Training Effects on Metabolic Syndrome Factors by Altering the Timing of Medication and Meal Ingestion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Castilla-La Mancha</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministerio de Economía y Competitividad, Spain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Servicio de Salud de Castilla-La Mancha</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Castilla-La Mancha</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To analyze the effects of altering the time of ingestion of participants' habitual medication&#xD;
      (i.e., metformin, statins, ARAII/IACE) and meals around the time of exercise training&#xD;
      (exercise fasted or fed) on the improvement of metabolic syndrome factors (hypertension,&#xD;
      insulin sensitivity, dyslipidemia, and obesity). There will be a preliminary study of the&#xD;
      effects of training &quot;time-of-day&quot; on the primary study outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: The purpose is to study in a group of adults with metabolic syndrome and obesity,&#xD;
      the effects of altering timing between exercise training, meals, and their habitual&#xD;
      medication on the improvement in the factors that compose the metabolic syndrome (i.e.,&#xD;
      hypertension, insulin resistance, central obesity, and dyslipidemia). The main objective is&#xD;
      to find the most productive combination between exercise training and the timing of their&#xD;
      habitual pharmacological treatment, and meal ingestion for lowering those factors.&#xD;
&#xD;
      Methods and design: Cross-over randomized double-blinded, pretest-posttest control group&#xD;
      experimental design. The project will be developed in a single center with the collaboration&#xD;
      of the regional public health system (SECAM). There will be a preliminary study of the&#xD;
      effects of training &quot;time-of-day&quot; on three parallel groups of individuals.&#xD;
&#xD;
      Subjects: Will be referred by their primary care physicians to our study unit or recruited by&#xD;
      advertisements in local media.&#xD;
&#xD;
      Up to 180 subjects, all of them with metabolic syndrome will be recruited (&gt;25% women).&#xD;
&#xD;
      Measurements:&#xD;
&#xD;
      Specifically, we will study if the cardiovascular and metabolic adaptations to aerobic&#xD;
      training that result in amelioration of metabolic syndrome factors are potentiated by correct&#xD;
      timming of training, meals, and medicine around exercise training time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 7, 2022</start_date>
  <completion_date type="Anticipated">December 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Cross-over randomized, pretest-posttest control group experimental design.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Habitual medicine will be embedded in bigger capsules along with a placebo to be able to randomly allocate medicine/placebo. The first meal in the morning will be also masked by either providing a non-caloric or caloric vanilla-flavored beverage resulting in the fed/fasted condition in a blinded fashion.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Insulin sensitivity assessed using intravenous glucose tolerance test</measure>
    <time_frame>12 months</time_frame>
    <description>Curves of insulin-mediated glucose clearance, inhibition of lipolysis, and liver glucose output measured with the use of stable isotope infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-prandial lipemia assessed by an oral fat tolerance test</measure>
    <time_frame>12 months</time_frame>
    <description>Rates of appearance and clearance of liver VLDL-TG, Apolipoprotein B, and fatty acids using stable isotopes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure assessed by ECG-gated automated sphygmomanometer</measure>
    <time_frame>12 months</time_frame>
    <description>Determined immediately after treatments and during the following 24-h using ambulatory blood pressure Holter-type monitors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycemic control assessed by 24-h continuous interstitial glucose monitoring</measure>
    <time_frame>36 months</time_frame>
    <description>Determined by a patch glucose sensor paired with a glucose monitor.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body composition.</measure>
    <time_frame>12 months</time_frame>
    <description>Determined by bioelectrical impedance to calculate body fat mass and fat free mass.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>12 months</time_frame>
    <description>Determined by body weight (kg) and height (m) to calculate body mass index (kg/m2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal oxygen consumption during a graded exercise test to exhaustion, assessed by indirect calorimetry</measure>
    <time_frame>12 months</time_frame>
    <description>Calculation of cardiorespitarory fitness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting metabolic rate assessed by indirect calorimetry while lying after an overnight fast</measure>
    <time_frame>12 months</time_frame>
    <description>Using indirect calorimetry and a ventilated canopy system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal rate of fat oxidation assessed by indirect calorimetry during a submaximal exercise test.</measure>
    <time_frame>12 months</time_frame>
    <description>Calculated in grams per min during the incremental cycle ergometer test with the use of indirect calorimetry system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24-hour monitoring of blood concentrations of metformin, statins, and angiotensin blockers assessed using gas chromatography-mass spectrometry.</measure>
    <time_frame>36 months</time_frame>
    <description>To study the pharmacokinetics of the habitual medicines used by our subjects during the different experimental conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The activity of intramuscular proteins (enzymes) involved in energetics assessed using western blots.</measure>
    <time_frame>36 months</time_frame>
    <description>Measured in skeletal muscle obtained by percutaneous muscle biopsy.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Metabolic Syndrome, Protection Against</condition>
  <condition>Exercise Training</condition>
  <condition>Metformin</condition>
  <condition>Statins</condition>
  <condition>Angiotensin-Converting-Enzyme Inhibitor</condition>
  <condition>Fasting, Intermittent</condition>
  <condition>Angiotensin Hypertension</condition>
  <arm_group>
    <arm_group_label>NO EXERCISE TRAINING</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>25-32 individuals with metabolic syndrome that will remain sedentary during the 4 months of treatment taking their habitual medication (i.e., blood pressure, glucose, cholesterol, and triglycerides lowering drugs) and meals at the habitual time (CONTROL GROUP).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EXERCISE TRAINING FED</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 groups of 25-32 individuals with metabolic syndrome that will exercise-train during 16 weeks after ingesting a liquid test meal (500 calls, 50% fat) 30 min before exercise (EXERCISE TRAINING FED).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EXERCISE TRAINING FASTED</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 groups of 25-32 individuals with metabolic syndrome that will exercise-train during 16 weeks after ingestion of a placebo meal (0 kcals) 30 min before exercise (EXERCISE TRAINING FAST).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EXERCISE TRAINING WITH OR WITHOUT MEDICATION</intervention_name>
    <description>A group will train 30 min after taking their habitual dose of medicine (MEDICATED train) while another group will train after taking a placebo (NON-MEDICATED train) and will receive their medication after training.</description>
    <arm_group_label>EXERCISE TRAINING FASTED</arm_group_label>
    <arm_group_label>EXERCISE TRAINING FED</arm_group_label>
    <other_name>Exercise timing with respect to medication (metformin, statins, ARAII/ACEI)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Metabolic syndrome patients diagnosed according to The International diabetes&#xD;
             federation consensus of 2009 (Alberti, et al., Circulation).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiovascular disease or musculo-skeletal that prevents them from being able to&#xD;
             perform intense exercise.&#xD;
&#xD;
               -  Respiratory failure&#xD;
&#xD;
               -  Liver o renal disease&#xD;
&#xD;
               -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>RICARDO M Mora-Rodriguez, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Castilla-La Mancha</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ricardo Mora-Rodriguez, PhD</last_name>
    <phone>925268800</phone>
    <email>ricardo.mora@uclm.es</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Juan F Ortega, MD, PhD</last_name>
    <phone>925268800</phone>
    <email>juanfernando.ortega@uclm.es</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Castilla-La Mancha (Exercise Physiology Lab)</name>
      <address>
        <city>Toledo</city>
        <zip>45071</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ricardo Mora-Rodriguez, PhD</last_name>
      <phone>92526800</phone>
      <phone_ext>5515</phone_ext>
      <email>ricardo.mora@uclm.es</email>
    </contact>
    <contact_backup>
      <last_name>Juan F Ortega, MD, PhD</last_name>
      <phone>+3492526800</phone>
      <phone_ext>5515</phone_ext>
      <email>juanfernando.ortega@uclm.es</email>
    </contact_backup>
    <investigator>
      <last_name>Juan F Ortega, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ricardo Mora-Rodriguez, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <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>
    <PMID>24682492</PMID>
  </reference>
  <reference>
    <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>
    <PMID>26667921</PMID>
  </reference>
  <reference>
    <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>
    <PMID>32598033</PMID>
  </reference>
  <reference>
    <citation>Mora-Rodriguez R, Ortega JF, Morales-Palomo F, Ramirez-Jimenez M, Moreno-Cabanas A. Effects of statin therapy and exercise on postprandial triglycerides in overweight individuals with hypercholesterolaemia. Br J Clin Pharmacol. 2020 Jun;86(6):1089-1099. doi: 10.1111/bcp.14217. Epub 2020 Feb 18.</citation>
    <PMID>31925809</PMID>
  </reference>
  <reference>
    <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>
    <PMID>31875915</PMID>
  </reference>
  <reference>
    <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>
    <PMID>31821339</PMID>
  </reference>
  <reference>
    <citation>Moreno-Cabanas A, Ortega JF, Morales-Palomo F, Ramirez-Jimenez M, Mora-Rodriguez R. Importance of a verification test to accurately assess V̇O2 max in unfit individuals with obesity. Scand J Med Sci Sports. 2020 Mar;30(3):583-590. doi: 10.1111/sms.13602. Epub 2019 Dec 11.</citation>
    <PMID>31746500</PMID>
  </reference>
  <reference>
    <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>
    <PMID>31415443</PMID>
  </reference>
  <reference>
    <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>
    <PMID>31158474</PMID>
  </reference>
  <reference>
    <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>
    <PMID>30459053</PMID>
  </reference>
  <reference>
    <citation>Ramirez-Jimenez M, Morales-Palomo F, Ortega JF, Mora-Rodriguez R. Effects of intense aerobic exercise and/or antihypertensive medication in individuals with metabolic syndrome. Scand J Med Sci Sports. 2018 Sep;28(9):2042-2051. doi: 10.1111/sms.13218. Epub 2018 Jun 4.</citation>
    <PMID>29771450</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>August 23, 2023</last_update_submitted>
  <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiorespiratory fitness</keyword>
  <keyword>Insulin sensitivity</keyword>
  <keyword>Dyslipidemia</keyword>
  <keyword>Hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Upon reasonable request</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04477590
org study id: DEP2017-83244-R
nct id: NCT04477590
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
To analyze the effects of altering the time of ingestion of participants' habitual medication
      (i.e., metformin, statins, ARAII/IACE) and meals around the time of exercise training
      (exercise fasted or fed) on the improvement of metabolic syndrome factors (hypertension,
      insulin sensitivity, dyslipidemia, and obesity). There will be a preliminary study of the
      effects of training "time-of-day" on the primary study outcomes.
Objective: The purpose is to study in a group of adults with metabolic syndrome and obesity,
      the effects of altering timing between exercise training, meals, and their habitual
      medication on the improvement in the factors that compose the metabolic syndrome (i.e.,
      hypertension, insulin resistance, central obesity, and dyslipidemia). The main objective is
      to find the most productive combination between exercise training and the timing of their
      habitual pharmacological treatment, and meal ingestion for lowering those factors.

      Methods and design: Cross-over randomized double-blinded, pretest-posttest control group
      experimental design. The project will be developed in a single center with the collaboration
      of the regional public health system (SECAM). There will be a preliminary study of the
      effects of training "time-of-day" on three parallel groups of individuals.

      Subjects: Will be referred by their primary care physicians to our study unit or recruited by
      advertisements in local media.

      Up to 180 subjects, all of them with metabolic syndrome will be recruited (>25% women).

      Measurements:

      Specifically, we will study if the cardiovascular and metabolic adaptations to aerobic
      training that result in amelioration of metabolic syndrome factors are potentiated by correct
      timming of training, meals, and medicine around exercise training time.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Cross-over randomized, pretest-posttest control group experimental design.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Habitual medicine will be embedded in bigger capsules along with a placebo to be able to randomly allocate medicine/placebo. The first meal in the morning will be also masked by either providing a non-caloric or caloric vanilla-flavored beverage resulting in the fed/fasted condition in a blinded fashion.
measure: Insulin sensitivity assessed using intravenous glucose tolerance test
time frame: 12 months
description: Curves of insulin-mediated glucose clearance, inhibition of lipolysis, and liver glucose output measured with the use of stable isotope infusion.
measure: Post-prandial lipemia assessed by an oral fat tolerance test
time frame: 12 months
description: Rates of appearance and clearance of liver VLDL-TG, Apolipoprotein B, and fatty acids using stable isotopes.
measure: Blood pressure assessed by ECG-gated automated sphygmomanometer
time frame: 12 months
description: Determined immediately after treatments and during the following 24-h using ambulatory blood pressure Holter-type monitors.
measure: Glycemic control assessed by 24-h continuous interstitial glucose monitoring
time frame: 36 months
description: Determined by a patch glucose sensor paired with a glucose monitor.
measure: Body composition.
time frame: 12 months
description: Determined by bioelectrical impedance to calculate body fat mass and fat free mass.
measure: Body mass index
time frame: 12 months
description: Determined by body weight (kg) and height (m) to calculate body mass index (kg/m2)
measure: Maximal oxygen consumption during a graded exercise test to exhaustion, assessed by indirect calorimetry
time frame: 12 months
description: Calculation of cardiorespitarory fitness
measure: Resting metabolic rate assessed by indirect calorimetry while lying after an overnight fast
time frame: 12 months
description: Using indirect calorimetry and a ventilated canopy system
measure: Maximal rate of fat oxidation assessed by indirect calorimetry during a submaximal exercise test.
time frame: 12 months
description: Calculated in grams per min during the incremental cycle ergometer test with the use of indirect calorimetry system
measure: 24-hour monitoring of blood concentrations of metformin, statins, and angiotensin blockers assessed using gas chromatography-mass spectrometry.
time frame: 36 months
description: To study the pharmacokinetics of the habitual medicines used by our subjects during the different experimental conditions
measure: The activity of intramuscular proteins (enzymes) involved in energetics assessed using western blots.
time frame: 36 months
description: Measured in skeletal muscle obtained by percutaneous muscle biopsy.
arm group label: NO EXERCISE TRAINING
arm group type: No Intervention
description: 25-32 individuals with metabolic syndrome that will remain sedentary during the 4 months of treatment taking their habitual medication (i.e., blood pressure, glucose, cholesterol, and triglycerides lowering drugs) and meals at the habitual time (CONTROL GROUP).
arm group label: EXERCISE TRAINING FED
arm group type: Experimental
description: 2 groups of 25-32 individuals with metabolic syndrome that will exercise-train during 16 weeks after ingesting a liquid test meal (500 calls, 50% fat) 30 min before exercise (EXERCISE TRAINING FED).
arm group label: EXERCISE TRAINING FASTED
arm group type: Experimental
description: 2 groups of 25-32 individuals with metabolic syndrome that will exercise-train during 16 weeks after ingestion of a placebo meal (0 kcals) 30 min before exercise (EXERCISE TRAINING FAST).
intervention type: Drug
intervention name: EXERCISE TRAINING WITH OR WITHOUT MEDICATION
description: A group will train 30 min after taking their habitual dose of medicine (MEDICATED train) while another group will train after taking a placebo (NON-MEDICATED train) and will receive their medication after training.
arm group label: EXERCISE TRAINING FASTED
arm group label: EXERCISE TRAINING FED
other name: Exercise timing with respect to medication (metformin, statins, ARAII/ACEI)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: RICARDO M Mora-Rodriguez, PhD
role: Principal Investigator
affiliation: University of Castilla-La Mancha
last name: Ricardo Mora-Rodriguez, PhD
phone: 925268800
email: ricardo.mora@uclm.es
last name: Juan F Ortega, MD, PhD
phone: 925268800
email: juanfernando.ortega@uclm.es
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Spain
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.
PMID: 24682492
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.
PMID: 26667921
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.
PMID: 32598033
citation: Mora-Rodriguez R, Ortega JF, Morales-Palomo F, Ramirez-Jimenez M, Moreno-Cabanas A. Effects of statin therapy and exercise on postprandial triglycerides in overweight individuals with hypercholesterolaemia. Br J Clin Pharmacol. 2020 Jun;86(6):1089-1099. doi: 10.1111/bcp.14217. Epub 2020 Feb 18.
PMID: 31925809
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.
PMID: 31875915
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.
PMID: 31821339
citation: Moreno-Cabanas A, Ortega JF, Morales-Palomo F, Ramirez-Jimenez M, Mora-Rodriguez R. Importance of a verification test to accurately assess V̇O2 max in unfit individuals with obesity. Scand J Med Sci Sports. 2020 Mar;30(3):583-590. doi: 10.1111/sms.13602. Epub 2019 Dec 11.
PMID: 31746500
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.
PMID: 31415443
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.
PMID: 31158474
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.
PMID: 30459053
citation: Ramirez-Jimenez M, Morales-Palomo F, Ortega JF, Mora-Rodriguez R. Effects of intense aerobic exercise and/or antihypertensive medication in individuals with metabolic syndrome. Scand J Med Sci Sports. 2018 Sep;28(9):2042-2051. doi: 10.1111/sms.13218. Epub 2018 Jun 4.
PMID: 29771450
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Metabolic Syndrome
mesh term: Syndrome
mesh term: Metformin
sharing ipd: No
ipd description: Upon reasonable request