Interactions of Medicine and Exercise With Meal Timing (MMET)

August 23, 2023 updated by: University of Castilla-La Mancha

Optimizing Exercise Training Effects on Metabolic Syndrome Factors by Altering the Timing of Medication and Meal Ingestion

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Toledo, Spain, 45071
        • Recruiting
        • University of Castilla-La Mancha (Exercise Physiology Lab)
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Juan F Ortega, MD, PhD
        • Principal Investigator:
          • Ricardo Mora-Rodriguez, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Exercise timing with respect to medication (metformin, statins, ARAII/ACEI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
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.
12 months
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.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition.
Time Frame: 12 months
Determined by bioelectrical impedance to calculate body fat mass and fat free mass.
12 months
Body mass index
Time Frame: 12 months
Determined by body weight (kg) and height (m) to calculate body mass index (kg/m2)
12 months
Maximal oxygen consumption during a graded exercise test to exhaustion, assessed by indirect calorimetry
Time Frame: 12 months
Calculation of cardiorespitarory fitness
12 months
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
12 months
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
12 months
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
36 months
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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Castilla-La Mancha

Collaborators

Ministerio de Economía y Competitividad, Spain
Servicio de Salud de Castilla-La Mancha

Investigators

  • Principal Investigator: RICARDO M Mora-Rodriguez, PhD, University of Castilla-La Mancha

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2022

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

June 28, 2020

First Submitted That Met QC Criteria

July 15, 2020

First Posted (Actual)

July 20, 2020

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEP2017-83244-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Upon reasonable request

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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