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Interactions of Medicine and Exercise With Meal Timing (MMET)

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ClinicalTrials.gov Identifier: NCT04477590
Recruitment Status : Not yet recruiting
First Posted : July 20, 2020
Last Update Posted : December 14, 2020
Sponsor:
Collaborators:
Ministerio de Economía y Competitividad, Spain
Servicio de Salud de Castilla-La Mancha (SESCAM)
Information provided by (Responsible Party):
University of Castilla-La Mancha

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Metabolic Syndrome, Protection Against Exercise Training Metformin Statins Angiotensin-Converting-Enzyme Inhibitor Fasting, Intermittent Angiotensin Hypertension Drug: EXERCISE TRAINING WITH OR WITHOUT MEDICATION Not Applicable

Detailed Description:

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 efficacious 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).

Subjects: Will be referred by their primary care physicians to our study unit or will be 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 meal and medicine around exercise training time.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Cross-over randomized, pretest-posttest control group experimental design.
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.
Primary Purpose: Treatment
Official Title: Optimizing Exercise Training Effects on Metabolic Syndrome Factors by Altering the Timing of Medication and Meal Ingestion
Estimated Study Start Date : June 7, 2021
Estimated Primary Completion Date : May 30, 2024
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: NO EXERCISE TRAINING
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).
Experimental: EXERCISE TRAINING FED
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).
Drug: EXERCISE TRAINING WITH OR WITHOUT MEDICATION
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.
Other Name: Exercise timing with respect to medication (metformin, statins, ARAII/ACEI)

Experimental: EXERCISE TRAINING FASTED
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).
Drug: EXERCISE TRAINING WITH OR WITHOUT MEDICATION
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.
Other Name: Exercise timing with respect to medication (metformin, statins, ARAII/ACEI)




Primary Outcome Measures :
  1. Insulin sensitivity assessed using intravenous glucose tolerance test [ Time Frame: 12 months ]
    Curves of insulin-mediated glucose clearance, inhibition of lipolysis, and liver glucose output measured with the use of stable isotope infusion.

  2. Post-prandial lipemia assessed by an oral fat tolerance test [ Time Frame: 12 months ]
    Rates of appearance and clearance of liver VLDL-TG, Apolipoprotein B, and fatty acids using stable isotopes.

  3. Blood pressure assessed by ECG-gated automated sphygmomanometer [ Time Frame: 12 months ]
    Determined immediately after treatments and during the following 24-h using ambulatory blood pressure Holter-type monitors.

  4. Glycemic control assessed by 24-h continuous interstitial glucose monitoring [ Time Frame: 36 months ]
    Determined by a patch glucose sensor paired with a glucose monitor.


Secondary Outcome Measures :
  1. Body composition. [ Time Frame: 12 months ]
    Determined by bioelectrical impedance to calculate body fat mass and fat free mass.

  2. Body mass index [ Time Frame: 12 months ]
    Determined by body weight (kg) and height (m) to calculate body mass index (kg/m2)

  3. Maximal oxygen consumption during a graded exercise test to exhaustion, assessed by indirect calorimetry [ Time Frame: 12 months ]
    Calculation of cardiorespitarory fitness

  4. Resting metabolic rate assessed by indirect calorimetry while lying after an overnight fast [ Time Frame: 12 months ]
    Using indirect calorimetry and a ventilated canopy system

  5. Maximal rate of fat oxidation assessed by indirect calorimetry during a submaximal exercise test. [ Time Frame: 12 months ]
    Calculated in grams per min during the incremental cycle ergometer test with the use of indirect calorimetry system

  6. 24-hour monitoring of blood concentrations of metformin, statins, and angiotensin blockers assessed using gas chromatography-mass spectrometry. [ Time Frame: 36 months ]
    To study the pharmacokinetics of the habitual medicines used by our subjects during the different experimental conditions

  7. The activity of intramuscular proteins (enzymes) involved in energetics assessed using western blots. [ Time Frame: 36 months ]
    Measured in skeletal muscle obtained by percutaneous muscle biopsy.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metabolic syndrome patients diagnosed according to The International diabetes federation consensus of 2009 (Alberti, et al., Circulation).

Exclusion Criteria:

  • Cardiovascular disease or musculo-skeletal that prevents them from being able to perform intense exercise.

    • Respiratory failure
    • Liver o renal disease
    • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04477590


Contacts
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Contact: Ricardo Mora-Rodriguez, PhD 925268800 ricardo.mora@uclm.es
Contact: Juan F Ortega, MD, PhD 925268800 juanfernando.ortega@uclm.es

Locations
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Spain
University of Castilla-La Mancha (Exercise Physiology Lab)
Toledo, Spain, 45071
Contact: Ricardo Mora-Rodriguez, PhD    92526800 ext 5515    ricardo.mora@uclm.es   
Contact: Juan F Ortega, MD, PhD    +3492526800 ext 5515    juanfernando.ortega@uclm.es   
Sub-Investigator: Juan F Ortega, MD, PhD         
Principal Investigator: Ricardo Mora-Rodriguez, PhD         
Sponsors and Collaborators
University of Castilla-La Mancha
Ministerio de Economía y Competitividad, Spain
Servicio de Salud de Castilla-La Mancha (SESCAM)
Investigators
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Principal Investigator: RICARDO M Mora-Rodriguez, PhD University of Castilla-La Mancha
Publications:

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Responsible Party: University of Castilla-La Mancha
ClinicalTrials.gov Identifier: NCT04477590    
Other Study ID Numbers: DEP2017-83244-R
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Upon reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Castilla-La Mancha:
Cardiorespiratory fitness
Insulin sensitivity
Dyslipidemia
Hypertension
Additional relevant MeSH terms:
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Hypertension
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs