Effect of Acute Exercise on Endothelial Function in Patients With Type 1 Diabetes. (EAEEFD)
Acute Effects of Aerobic and Resistance Exercise on Endothelial Function in Patients With Type 1 Diabetes.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The aim of this study is to compare the effect of endurance and resistance exercises on endothelial function in patients with type 1 diabetes mellitus (T1DM). For this purpose, the sample size will consist of 15 patients with DM1, aged between 18 and 45 years, which will undertake the two types of exercises, randomly distributed. Ergospirometry testing will be performed in order to assess possible contraindications to the proposed protocol as well as functional capacity, which will be used in prescription of the endurance exercise session. Similarly, a strength maximal testing will be conducted and used in the prescription of the resistance exercise session.
The endothelial function will be evaluated by vascular reactivity of the forearm and circulating endothelial progenitor cells (EPC) counting. To analyze the vascular reactivity of the forearm, non-invasive venous occlusion plethysmography will be used, whereas flow cytometry method will be used to the analysis of the number of circulating EPC. The endurance exercise session will consist of 40 minutes of cycling on heart rate corresponding to 60% of VO2 max. The resistance exercise session will last 40 minutes, consisting of 4 sets of 12 repetitions at 60% of 1RM, in four exercises for lower limbs. The research will be performed at the Exercise Pathophysiology Research Laboratory of the Hospital de Clinicas de Porto Alegre. The investigators expect to find greater increase in the number of circulating EPC after the endurance exercise session, when compared to the benefits obtained from a session of resistance exercise. Likewise, it is expected to find greater benefits in relation to vascular reactivity of the forearm after a session of endurance exercise when compared to a session of resistance exercise. Considering that most part of the studies that analyze the effects of physical exercise on vascular function does not involve patients with DM1, this project aims to provide a clearer picture of the benefits of different exercises in the acute response of endothelial function in these patients.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Beatriz D'Agord Schaan, Phd
- Número de teléfono: 51-33598127
- Correo electrónico: beatrizschaan@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Gustavo Waclawovsky, Masters student
- Número de teléfono: 51-33596332
- Correo electrónico: gwsaude@yahoo.com.br
Ubicaciones de estudio
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasil, 90035903
- Reclutamiento
- Hospital de Clinicas de Porto Alegre
-
Contacto:
- Gustavo Waclawovsky, Masters
- Número de teléfono: 51-33596332
- Correo electrónico: gwsaude@yahoo.com.br
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Type 1 diabetes
- Male gender
- 18-45 years old
Exclusion Criteria:
- Severe autonomic neuropathy
- Diabetic nephropathy established
- Chronic kidney failure
- Limb amputation
- Disabling peripheral arterial disease
- Coronary artery disease
- Heart failure
- Diabetic proliferative retinopathy
- Neoplasms
- Smokers
- Regular physical training
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Patients with type 1 diabetes
|
Resistance exercise session consisting of 4 lower-limb exercises, with 4 sets, 12 repetitions per set, at an intensity of 60% of maximal strength.
Aerobic exercise session consisting of 40 minutes of lower-limb bicycle.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Circulating endothelial progenitor cells
Periodo de tiempo: 10 minutes before the exercise session and 10 minutes after the exercise session.
|
A 20-ml sodium heparin tube will be used and peripheral blood mononuclear cells (PBMC) will be isolated by Ficoll-Hypaque.
Blood samples will be diluted with PBS and layered onto Ficoll-Hypaque in 15-ml tubes.
Tubes will be centrifuged at 400 g for 30 min and the PBMC at the interface will be collected.
Cells will be washed with RPMI 1640 medium and thereafter stained with 5 µl of anti-CD45-FITC , 8 µl of anti-KDR-Alexa Fluor 647, and 5 µl of anti-CD34-PE (all essays from BD, Biosciences, USA).
Thereafter, 50 µl of resuspended cells will be incubated (30 min), and subsequently, 500 µl of PBS will be added for acquisition.
A FACS Calibur flow cytometer will be used with Quest software (BD Biosciences, USA) equipped with 22 mW argon laser tuned at 488 nm, with a total number counted cells of 200,000 on mononuclear cells gate per sample.
Percentage of CD34 positive cells will be calculated based on the number of leukocytes .
|
10 minutes before the exercise session and 10 minutes after the exercise session.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Forearm vascular reactivity
Periodo de tiempo: 10 minutes before the exercise session and 10 minutes after the exercise session.
|
Forearm blood flow and reactive hyperemia: Forearm blood flow will be measured by venous occlusion plethysmography (D.E Hokanson, USA) at the nondominant forearm. A rapid inflator cuff will be used in the upper arm to occlude venous outflow (50-60 mmHg), and three blood flow recordings will be made each minute during 3 minutes. Thereafter, reactive hyperemia will be measure using an occlusion at 250 mmHg for 5 min, which will be released by 10 seconds intervals for 2 minutes. Reactive hyperemia will be calculated using the peak blood flow after the 5 minutes the occlusion. |
10 minutes before the exercise session and 10 minutes after the exercise session.
|
Colaboradores e Investigadores
Patrocinador
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
- 100400
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Diabetes mellitus tipo 1
-
University of California, San FranciscoJuvenile Diabetes Research FoundationTerminadoDiabetes mellitus tipo 1 | Diabetes Mellitus, Tipo I | Diabetes mellitus insulinodependiente 1 | Diabetes Mellitus, Insulino-Dependiente, 1 | IDDMEstados Unidos, Australia
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.TerminadoDiabetes Mellitus, Tipo 1 | Diabetes tipo 1 | Diabetes tipo 1 | Diabetes mellitus tipo 1 | Diabetes autoinmune | Diabetes Mellitus, Insulino-Dependiente | Diabetes de inicio juvenil | Diabetes Autoinmune | Diabetes mellitus insulinodependiente 1 | Diabetes Mellitus, Insulino-Dependiente, 1 | Diabetes Mellitus... y otras condicionesEstados Unidos
-
Capillary Biomedical, Inc.TerminadoDiabetes Mellitus, Tipo 1 | Diabetes tipo 1 | Diabetes mellitus tipo 1 | Diabetes Mellitus, Insulino-Dependiente, 1Australia
-
Spiden AGDCB Research AGReclutamientoDiabetes mellitus tipo 1 | Diabetes mellitus tipo 1 con hipoglucemia | Diabetes mellitus tipo 1 con hiperglucemiaSuiza
-
Instytut Diabetologii Sp. z o.o.National Center for Research and Development, Poland; Nalecz Institute of Biocybernetics...DesconocidoDiabetes mellitus tipo 1 con hiperglucemia | Diabetes mellitus tipo 1 con hipoglucemiaPolonia
-
Capillary Biomedical, Inc.TerminadoDiabetes tipo 1 | Diabetes mellitus tipo 1 | Diabetes Mellitus, Tipo I | Diabetes Mellitus, Insulino-Dependiente, 1 | IDDMAustria
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)TerminadoDiabetes mellitus tipo 1 | DM1 | DT1 | Diabetes mellitus tipo 1 de nueva apariciónEstados Unidos, Australia
-
Shanghai Changzheng HospitalReclutamientoDiabetes mellitus frágil tipo 1Porcelana
-
SanofiTerminadoDiabetes Mellitus Tipo 1-Diabetes Mellitus Tipo 2Hungría, Federación Rusa, Alemania, Polonia, Japón, Estados Unidos, Finlandia
-
Hoffmann-La RocheRoche DiagnosticsTerminadoDiabetes Mellitus Tipo 2, Diabetes Mellitus Tipo 1Alemania
Ensayos clínicos sobre Resistance exercise session
-
Sheba Medical CenterReclutamientoRecopilación de datos | CuestionariosIsrael
-
Florida State UniversityNational Institute on Drug Abuse (NIDA); National Center for Advancing Translational...TerminadoVIH/SIDA | Enfermedad infecciosa | Uso de sustancias | Adultos mayores | Intervención conductualEstados Unidos