Acute Effects of Inspiratory Muscle Exercise on Glucose Level and Glucose Variability in Patients With Type 2 Diabetes.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
High-intensity exercise of inspiratory muscle was able to reduce glucose levels in previous studies, but the mechanisms underlying this reduction remain largely unknown. The present study will investigate this phenomenon, and whether confirmed, the inspiratory muscle loading would be a new approach for lowering glucose levels and glucose variability in type 2 diabetes.
The subjects with type 2 diabetes will be recruited from the ambulatory of the Hospital de Clinicas de Porto Alegre. The patients will be randomized to inspiratory muscle exercise with a high intensity load (MIP 60%) or to exercise with a load placebo (MIP 2%), on two different days. The subjects will come in the laboratory for three days consecutively during 2 weeks. On the first day will be placed the CGMS device. On the second day will be the controlled ventilation protocol with subsequently inspiratory muscle exercise, using 2% or 60% of MIP as randomized a priori. On the third day the CGMS will be removed. Individuals who are using beta-blockers will be advised to withdraw the medication 24 hours before the protocols. During all protocols will be recorded the continuous blood pressure to assess heart rate and blood pressure variabilities, both time and frequency domains will be analyzed. Also, the calf blood flow, inspiratory pressure, end-tidal carbon dioxide and oxygen saturation will be taking.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Type 2 diabetes;
- HbA1c from 7,5 to 10%;
Exclusion Criteria:
- Subjects taking insulin;
- Pregnant women;
- Subjects taking betablocker only
- Documented arrythmia
- Documented fibrillation
- GFR<30
- Documented pulmonary disease or asthma,
- Current smoking;
- Varicose vein problems;
- Musculoskeletal disease.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Inspiratory muscle exercise
Patients will exercise the inspiratory muscle using a load of 60% of maximum inspiratory mouth pressure (MIP 60%).
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For inspiratory muscle exercise patients will breathe with a high load of 60% of MIP using a respiratory frequency of 15 breaths min and a prolonged duty cycle (TI/TTOT =0.7) until task failure.
The blood flow, conductance and resistance arterial will be measured in the calf using plethysmography device.
Arterial blood pressure and heart rate will be monitored continuously at the finger on a beat-by-beat basis by biopac equipment and the glucose levels will be captured by continuous glucose monitoring system.
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Comparador de placebos: Inspiratory muscle exercise placebo
Patients will exercise the inspiratory muscle using a load of 2% of maximum inspiratory mouth pressure (MIP 2%).
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For inspiratory muscle exercise patients will breathe with a very low load of 2% of MIP using a respiratory frequency of 15 breaths min and a prolonged duty cycle (TI/TTOT =0.7) for 10 minute.
The blood flow, conductance and resistance arterial will be measured in the calf using plethysmography device.
Arterial blood pressure and heart rate will be monitored continuously at the finger on a beat-by-beat basis by biopac equipment and the glucose levels will be captured by using the continuous glucose monitoring system.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Glucose level
Periodo de tiempo: 1 day (A session of inspiratory muscle exercise)
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The glucose level will be assessed by continuous glucose monitoring (CGMS) before and after exercise.
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1 day (A session of inspiratory muscle exercise)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Glucose variability
Periodo de tiempo: 3 days
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The variability of the glucose will be assessed by continuous glucose monitoring (CGMS) 24 hours before exercise, during the protocol and 24 hours after exercise.
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3 days
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Autonomic control
Periodo de tiempo: 1 day (A session of inspiratory muscle exercise)
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The autonomic control will be evaluated in the time domain and frequency through the Biopac.
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1 day (A session of inspiratory muscle exercise)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Beatriz Schaan, PhD, Hospital de Clinicas de Porto Alegre
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 14-0194
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