Interactions of Medicine and Exercise With Meal Timing

NCT04477590 | Unknown DMC

• 1 other identifier: DEP2017-83244-R
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cardiorespiratory fitness; Insulin sensitivity; Dyslipidemia; Hypertension

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Glycemic control assessed by 24-h continuous interstitial glucose monitoring

  Determined by a patch glucose sensor paired with a glucose monitor.

  36 months

Secondary Outcomes (7)

• Body composition.

  12 months

• Body mass index

  12 months

• Maximal oxygen consumption during a graded exercise test to exhaustion, assessed by indirect calorimetry

  12 months

• Resting metabolic rate assessed by indirect calorimetry while lying after an overnight fast

  12 months

• Maximal rate of fat oxidation assessed by indirect calorimetry during a submaximal exercise test.

  12 months

Study Arms (3)

NO EXERCISE TRAINING

NO INTERVENTION

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).

EXERCISE TRAINING FED

EXPERIMENTAL

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

EXERCISE TRAINING FASTED

EXPERIMENTAL

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

Interventions

EXERCISE TRAINING WITH OR WITHOUT MEDICATION DRUG

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.

Also known as: Exercise timing with respect to medication (metformin, statins, ARAII/ACEI)

EXERCISE TRAINING FASTED; EXERCISE TRAINING FED

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cardiovascular disease or musculo-skeletal that prevents them from being able to perform intense exercise.
• Respiratory failure
• Liver o renal disease
• Pregnancy

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Ministerio de Economía y Competitividad, Spain: collaborator
• Servicio de Salud de Castilla-La Mancha: collaborator

Study Sites (1)

University of Castilla-La Mancha (Exercise Physiology Lab)

Toledo, 45071, Spain

RECRUITING

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Intermittent Fasting; Insulin Resistance; Dyslipidemias; Hypertension

Interventions

Exercise; Dosage Forms; Metformin; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fasting; Feeding Behavior; Behavior; Lipid Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Biguanides; Guanidines; Amidines; Organic Chemicals; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• RICARDO M Mora-Rodriguez, PhD

  University of Castilla-La Mancha

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo Mora-Rodriguez, PhD

CONTACT

925268800; ricardo.mora@uclm.es

Juan F Ortega, MD, PhD

CONTACT

925268800; juanfernando.ortega@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-over randomized, pretest-posttest control group experimental design.

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 20, 2020
• Study Start: June 7, 2022
• Primary Completion: May 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)