Clinical trial

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

Name

DEP2017-83244-R

Description

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.

Trial arms

Trial start

2022-06-07

Estimated PCD

2024-05-30

Trial end

2024-12-30

Status

Recruiting

Treatment

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.

Arms:

EXERCISE TRAINING FASTED, EXERCISE TRAINING FED

Other names:

Exercise timing with respect to medication (metformin, statins, ARAII/ACEI)

Size

160

Primary endpoint

Insulin sensitivity assessed using intravenous glucose tolerance test

12 months

Post-prandial lipemia assessed by an oral fat tolerance test

12 months

Blood pressure assessed by ECG-gated automated sphygmomanometer

12 months

Glycemic control assessed by 24-h continuous interstitial glucose monitoring

36 months

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Cross-over randomized, pretest-posttest control group experimental design.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}

Updated at

2023-08-25

1 organization

1 product

9 indications

Organization

University of Castilla-La Mancha

Product

Exercise Training

Indication

Metabolic Syndrome

Indication