Interactions of Medicine and Exercise With Meal Timing

Exercise Training Clinical Trial

— MMET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04477590
• Other study ID #: DEP2017-83244-R
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: August 2023
• Source: University of Castilla-La Mancha
• Contact: Ricardo Mora-Rodriguez, PhD
• Phone: 925268800
• Email: ricardo.mora[@]uclm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Angiotensin Hypertension
• Angiotensin-Converting-Enzyme Inhibitor
• Exercise Training
• Fasting, Intermittent
• Hypertension
• Metabolic Syndrome
• Metabolic Syndrome, Protection Against
• Metformin
• Statins
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Spain	University of Castilla-La Mancha (Exercise Physiology Lab)	Toledo

Sponsors (3)

Lead Sponsor	Collaborator
University of Castilla-La Mancha	Ministerio de Economía y Competitividad, Spain, Servicio de Salud de Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Moreno-Cabanas A, Ortega JF, Morales-Palomo F, Ramirez-Jimenez M, Mora-Rodriguez R. Importance of a verification test to accurately assess V?O2 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity assessed using intravenous glucose tolerance test	Curves of insulin-mediated glucose clearance, inhibition of lipolysis, and liver glucose output measured with the use of stable isotope infusion.	12 months
Primary	Post-prandial lipemia assessed by an oral fat tolerance test	Rates of appearance and clearance of liver VLDL-TG, Apolipoprotein B, and fatty acids using stable isotopes.	12 months
Primary	Blood pressure assessed by ECG-gated automated sphygmomanometer	Determined immediately after treatments and during the following 24-h using ambulatory blood pressure Holter-type monitors.	12 months
Primary	Glycemic control assessed by 24-h continuous interstitial glucose monitoring	Determined by a patch glucose sensor paired with a glucose monitor.	36 months
Secondary	Body composition.	Determined by bioelectrical impedance to calculate body fat mass and fat free mass.	12 months
Secondary	Body mass index	Determined by body weight (kg) and height (m) to calculate body mass index (kg/m2)	12 months
Secondary	Maximal oxygen consumption during a graded exercise test to exhaustion, assessed by indirect calorimetry	Calculation of cardiorespitarory fitness	12 months
Secondary	Resting metabolic rate assessed by indirect calorimetry while lying after an overnight fast	Using indirect calorimetry and a ventilated canopy system	12 months
Secondary	Maximal rate of fat oxidation assessed by indirect calorimetry during a submaximal exercise test.	Calculated in grams per min during the incremental cycle ergometer test with the use of indirect calorimetry system	12 months
Secondary	24-hour monitoring of blood concentrations of metformin, statins, and angiotensin blockers assessed using gas chromatography-mass spectrometry.	To study the pharmacokinetics of the habitual medicines used by our subjects during the different experimental conditions	36 months
Secondary	The activity of intramuscular proteins (enzymes) involved in energetics assessed using western blots.	Measured in skeletal muscle obtained by percutaneous muscle biopsy.	36 months