Interactions of Medicine and Exercise With Meal Timing
Ключови думи
Резюме
Описание
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 efficacious 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).
Subjects: Will be referred by their primary care physicians to our study unit or will be recruited by advertisements in local media.
Up to 160 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 meal and medicine around exercise training time.
Дати
Последна проверка: | 06/30/2020 |
Първо изпратено: | 06/27/2020 |
Очаквано записване подадено: | 07/14/2020 |
Първо публикувано: | 07/19/2020 |
Изпратена последна актуализация: | 07/14/2020 |
Последна актуализация публикувана: | 07/19/2020 |
Действителна начална дата на проучването: | 09/06/2020 |
Приблизителна дата на първично завършване: | 05/29/2023 |
Очаквана дата на завършване на проучването: | 12/29/2023 |
Състояние или заболяване
Интервенция / лечение
Drug: EXERCISE TRAINING WITH OR WITHOUT MEDICATION
Фаза
Групи за ръце
Arm | Интервенция / лечение |
---|---|
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). | |
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). |
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
Полове, допустими за проучване | All |
Приема здрави доброволци | Да |
Критерии | 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 |
Резултат
Първични изходни мерки
1. Insulin sensitivity assessed using intravenous glucose tolerance test [12 months]
2. Post-prandial lipemia assessed by an oral fat tolerance test [12 months]
3. Blood pressure assessed by ECG-gated automated sphygmomanometer [12 months]
4. Glycemic control assessed by 24-h continuous interstitial glucose monitoring [36 months]
Вторични изходни мерки
1. Body composition. [12 months]
2. Body mass index [12 months]
3. Maximal oxygen consumption during a graded exercise test to exhaustion, assessed by indirect calorimetry [12 months]
4. Resting metabolic rate assessed by indirect calorimetry while lying after an overnight fast [12 months]
5. Maximal rate of fat oxidation assessed by indirect calorimetry during a submaximal exercise test. [12 months]
6. 24-hour monitoring of blood concentrations of metformin, statins, and angiotensin blockers assessed using gas chromatography-mass spectrometry. [36 months]
7. The activity of intramuscular proteins (enzymes) involved in energetics assessed using western blots. [36 months]