High-intensity Interval, Low Volume Training in Metabolic Syndrome (Intraining-MET)
Efficacy of High-intensity Interval, Low-volume Training Compared to Continuous Aerobic Exercise on Insulin Resistance, Skeletal Muscle Composition and Endocrine Function in Adults With Metabolic Syndrome: a Randomized Controlled Clinical Trial (Intraining-MET)
The primary objective of the study is to compare the efficacy of an intervention with high-intensity interval, low volume training (HIIT-LV) or continuous aerobic exercise (CAE) on insulin resistance, insulin sensitivity and percentage of pancreatic β-cell function in adults with metabolic syndrome (MS).
The secondary objective is to compare the efficacy of an intervention with HIIT-LV or CAE on glycosylated hemoglobin, mass and muscle fibre type composition of right thigh and plasma levels of musclin and apelin in adults with MS.
The investigators hypothesized that HIIT-LV is more effective in decreasing insulin resistance and glycosylated hemoglobin and plasma concentrations of musclin and increasing plasma concentrations of apelin, and both mass and muscle fibre type I percentage in thigh, than CAE.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is a randomized, controlled, masked (single blind, outcomes assessor) clinical trial, with allocation by the minimization method, with two parallel groups and intention of superiority. It was designed to test the hypothesis that a 12-week program of HIIT-LV, yields larger beneficial effects on insulin resistance, skeletal muscle composition and endocrine function than CAE.
Although aerobic exercise increases cardio-respiratory capacity, modifies risk factors and decreases mortality risk, there is currently controversy and gaps in knowledge over the efficacy of more intense and low-volume physical activities on muscle metabolism in patients with metabolic disorders.
The primary outcome will be the insulin resistance, insulin sensitivity and percentage of pancreatic β-cell function. The secondary outcomes will be the glycosylated hemoglobin, mass and muscle fibre type composition of thigh and plasma levels of musclin and apelin. Assessments will be made before and after the 12-week program. Calculations based on previously results (difference mean 10% and SD 15%) suggest that a total number of 60 patients randomized 1:1 (30 in each group) to the two intervention groups is sufficient to detect larger beneficial effects with HIIT-LV with a p-value of 0.05 (two-sided test) and statistical power of 0.80 (primary endpoint is insulin sensitivity).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Antioquia
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Medellin, Antioquia, Colombia
- IPS-Universitaria
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Metabolic syndrome defined according to the International Diabetes Federation-criteria.
- Insulin resistance defined according to the HOMA greater than 2.25
- Sedentary lifestyle (less than 60 min of physical activity per week)
Exclusion Criteria:
- Vegetarian diet
- Vitamin D3 supplementation
- Oral contraceptives
- Musculoskeletal diseases or injuries
- Physical, sensory or cognitive impairment
- History of cardiovascular disease (coronary, cerebrovascular, peripheral arterial disease, uncontrolled cardiac arrhythmias).
- Pulmonary diseases
- Acute or chronic inflammatory conditions
- Cancer
- Human immunodeficiency virus infection
- Diabetes mellitus
- Hyperthyroidism
- Pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 1x2 HIIT-LV, 3 times a week, 24 min
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Supervised endurance treadmill training as walking/running "uphill", 3 times/week during 12 weeks starting at 85-90% of previously determined maximum oxygen consumption (VO2 max).
Warm-up 3 min at 30% of VO2 max, 3 min cool-down.
Progression in intensity every 3erd week.
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Comparador activo: CAE, moderate intensity, 3 times a week, 36 min
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Supervised moderate intensity treadmill training, 3 times/week for 12 weeks starting at 70% of VO2 max.
Warm-up 3 min at 30% of VO2 max, 3 min cool-down.
Progression in intensity every 3erd week.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Insulin sensitivity
Periodo de tiempo: 12-week
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Using HOMA model (units as percentages of a normal reference population)
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12-week
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Insulin resistance
Periodo de tiempo: 12-week
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Using HOMA model (arbitrary units)
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12-week
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Pancreatic β-cell function
Periodo de tiempo: 12-week
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Using HOMA model (units as percentages of a normal reference population)
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12-week
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Glycosylated hemoglobin
Periodo de tiempo: 12-week
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Using blood tests (%)
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12-week
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Mass muscle of right thigh
Periodo de tiempo: 12-week
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Using dual energy x-ray absorptiometry (DEXA) (kg/m2)
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12-week
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Muscle fibre type composition of right thigh
Periodo de tiempo: 12-week
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Using carnosine quantification by hydrogen magnetic resonance spectroscopy (1H-MRS) (% fibre type I)
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12-week
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Musclin
Periodo de tiempo: 12-week
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Using plasma levels of musclin (pg/mL)
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12-week
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Apelin
Periodo de tiempo: 12-week
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Using plasma levels of apelin (pg/mL)
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12-week
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Juan Calderón, MD, PhD, Professor
- Director de estudio: Daniel Aguirre, PhD, Professor
Publicaciones y enlaces útiles
Publicaciones Generales
- Gallo-Villegas J, Restrepo D, Perez L, Castro-Valencia LA, Narvaez-Sanchez R, Osorio J, Aguirre-Acevedo DC, Calderon JC. Safety of High-Intensity, Low-Volume Interval Training or Continuous Aerobic Training in Adults With Metabolic Syndrome. J Patient Saf. 2022 Jun 1;18(4):295-301. doi: 10.1097/PTS.0000000000000922. Epub 2021 Sep 20.
- Aristizabal JC, Montoya E, Sanchez YL, Yepes-Calderon M, Narvaez-Sanchez R, Gallo-Villegas JA, Calderon JC. Effects of Low-Volume, High-Intensity Interval Training Compared with Continuous Training on Regional and Global Body Composition in Adults with Metabolic Syndrome: A post hoc Analysis of a Randomized Clinical Trial. Ann Nutr Metab. 2021;77(5):279-288. doi: 10.1159/000518909. Epub 2021 Oct 6.
- Gallo-Villegas J, Castro-Valencia LA, Perez L, Restrepo D, Guerrero O, Cardona S, Sanchez YL, Yepes-Calderon M, Valbuena LH, Pena M, Milan AF, Trillos-Almanza MC, Granados S, Aristizabal JC, Estrada-Castrillon M, Narvaez-Sanchez R, Osorio J, Aguirre-Acevedo DC, Calderon JC. Efficacy of high-intensity interval- or continuous aerobic-training on insulin resistance and muscle function in adults with metabolic syndrome: a clinical trial. Eur J Appl Physiol. 2022 Feb;122(2):331-344. doi: 10.1007/s00421-021-04835-w. Epub 2021 Oct 23.
- Gallo-Villegas J, Aristizabal JC, Estrada M, Valbuena LH, Narvaez-Sanchez R, Osorio J, Aguirre-Acevedo DC, Calderon JC. Efficacy of high-intensity, low-volume interval training compared to continuous aerobic training on insulin resistance, skeletal muscle structure and function in adults with metabolic syndrome: study protocol for a randomized controlled clinical trial (Intraining-MET). Trials. 2018 Feb 27;19(1):144. doi: 10.1186/s13063-018-2541-7.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 54-2016
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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