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| Name | Class |
|---|---|
| Ministerio de Economía y Competitividad, Spain | OTHER_GOV |
| Servicio de Salud de Castilla-La Mancha | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition. | Determined by bioelectrical impedance to calculate body fat mass and fat free mass. | 12 months |
| Body mass index | Determined by body weight (kg) and height (m) to calculate body mass index (kg/m2) |
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Inclusion Criteria:
Exclusion Criteria:
Cardiovascular disease or musculo-skeletal that prevents them from being able to perform intense exercise.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ricardo Mora-Rodriguez, PhD | Contact | 925268800 | ricardo.mora@uclm.es | |
| Juan F Ortega, MD, PhD | Contact | 925268800 | juanfernando.ortega@uclm.es |
| Name | Affiliation | Role |
|---|---|---|
| RICARDO M Mora-Rodriguez, PhD | University of Castilla-La Mancha | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Castilla-La Mancha (Exercise Physiology Lab) | Recruiting | Toledo | 45071 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24682492 | Background | 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. | |
| 26667921 | Background |
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Upon reasonable request
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D000093763 | Intermittent Fasting |
| D007333 | Insulin Resistance |
| D050171 | Dyslipidemias |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D004304 | Dosage Forms |
| D008687 | Metformin |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Cross-over randomized, pretest-posttest control group experimental design.
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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.
|
| 12 months |
| Maximal oxygen consumption during a graded exercise test to exhaustion, assessed by indirect calorimetry | Calculation of cardiorespitarory fitness | 12 months |
| Resting metabolic rate assessed by indirect calorimetry while lying after an overnight fast | Using indirect calorimetry and a ventilated canopy system | 12 months |
| 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 |
| 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 |
| The activity of intramuscular proteins (enzymes) involved in energetics assessed using western blots. | Measured in skeletal muscle obtained by percutaneous muscle biopsy. | 36 months |
| 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. |
| 32598033 | 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. |
| 31925809 | 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. |
| 31875915 | 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. |
| 31821339 | 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. |
| 31746500 | 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. |
| 31415443 | 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. |
| 31158474 | 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. |
| 30459053 | 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. |
| 29771450 | 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. |
| 38015017 | Derived | Morales-Palomo F, Moreno-Cabanas A, Alvarez-Jimenez L, Mora-Gonzalez D, Ortega JF, Mora-Rodriguez R. Efficacy of morning versus afternoon aerobic exercise training on reducing metabolic syndrome components: A randomized controlled trial. J Physiol. 2024 Dec;602(23):6463-6477. doi: 10.1113/JP285366. Epub 2023 Nov 28. |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D052439 | Lipid Metabolism Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |