Interactions of Medicine and Exercise With Meal Timing

Not Applicable

Recruiting

• Conditions: Metformin; Exercise Training; Metabolic Syndrome, Protection Against; Angiotensin-Converting-Enzyme Inhibitor; Fasting, Intermittent; Statins; Angiotensin Hypertension
• Interventions: Drug: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

• Registration Number: NCT04477590
• Lead Sponsor: 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). There will be a preliminary study of the effects of training "time-of-day" on the primary study outcomes.

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 Timeline

• Study First Submitted: 2020-06-28
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-20
• Study Start: 2022-06-07
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-25
• Primary Completion: 2024-05-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
EXERCISE TRAINING FED	EXERCISE TRAINING WITH OR WITHOUT MEDICATION	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).
EXERCISE TRAINING FASTED	EXERCISE TRAINING WITH OR WITHOUT MEDICATION	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).

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity assessed using intravenous glucose tolerance test	12 months	Curves of insulin-mediated glucose clearance, inhibition of lipolysis, and liver glucose output measured with the use of stable isotope infusion.
Post-prandial lipemia assessed by an oral fat tolerance test	12 months	Rates of appearance and clearance of liver VLDL-TG, Apolipoprotein B, and fatty acids using stable isotopes.
Blood pressure assessed by ECG-gated automated sphygmomanometer	12 months	Determined immediately after treatments and during the following 24-h using ambulatory blood pressure Holter-type monitors.
Glycemic control assessed by 24-h continuous interstitial glucose monitoring	36 months	Determined by a patch glucose sensor paired with a glucose monitor.

Secondary Outcome Measures

Name	Time	Method
24-hour monitoring of blood concentrations of metformin, statins, and angiotensin blockers assessed using gas chromatography-mass spectrometry.	36 months	To study the pharmacokinetics of the habitual medicines used by our subjects during the different experimental conditions
Body mass index	12 months	Determined by body weight (kg) and height (m) to calculate body mass index (kg/m2)
Resting metabolic rate assessed by indirect calorimetry while lying after an overnight fast	12 months	Using indirect calorimetry and a ventilated canopy system
Body composition.	12 months	Determined by bioelectrical impedance to calculate body fat mass and fat free mass.
Maximal oxygen consumption during a graded exercise test to exhaustion, assessed by indirect calorimetry	12 months	Calculation of cardiorespitarory fitness
Maximal rate of fat oxidation assessed by indirect calorimetry during a submaximal exercise test.	12 months	Calculated in grams per min during the incremental cycle ergometer test with the use of indirect calorimetry system
The activity of intramuscular proteins (enzymes) involved in energetics assessed using western blots.	36 months	Measured in skeletal muscle obtained by percutaneous muscle biopsy.

Trial Locations

Locations (1)

University of Castilla-La Mancha (Exercise Physiology Lab); 🇪🇸 Toledo, Spain