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Training, Detraining, Retraining and Glycemic Control in Patients With Type 2 Diabetes

18 de abril de 2012 actualizado por: Savvas P. Tokmakidis, Ph.D., Democritus University of Thrace

Training, Detraining and Retraining Effects on Glycemic Control and Physical Fitness in Patients With Type 2 Diabetes

  • This study examine the effects of training, detraining and retraining, using a combined strength and aerobic exercise program, on physiological parameters in patients with type 2 diabetes.
  • Thirteen women with type 2 diabetes followed a supervised aerobic and strength training program for 9 months, interrupted for 3 months (detraining) and resumed again for a period of 9 months (retraining).
  • Training improved body mass index, fasting plasma glucose,postprandial glucose, glycosylated hemoglobin, peak oxygen consumption,power output and total muscle strength. Detraining reversed PPG, HbA1C and physical fitness parameters. Resumption of training however, improved further the initial training adaptations.
  • Diabetic patients should follow a regular and uninterrupted exercise program throughout life in order to control glucose metabolism and improve health status.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

During the last decades, the positive effects of aerobic exercise in patients with type 2 diabetes have been well documented. Recently, resistance exercise has gained popularity in diabetic patients since several studies have indicated that this type of training is safe and induces favorable adaptations in physical fitness and metabolic profile. According to recent scientific evidence, a complete rehabilitation program for patients with type 2 diabetes should combine both strength and aerobic exercise; thus the American Diabetic Association in their latest guidelines recommends strength training as part of an exercise program at least two times a week.

On the contrary to the well documented effects of physical training, there is lack of data on the negative alterations of detraining in patients with type 2 diabetes. The partial or complete loss of training-induced adaptations as a consequence of training reduction or cessation is well-documented by several detraining studies in healthy subjects, older individuals and patients with coronary artery disease.

For example, the investigators know that even 6 days of physical inactivity reduces insulin action in well-trained runners which is attributed to the significant reduction in the muscle GLUT-4 level. Factors such as illness, injury, travel or vacation may interrupt the training process for longer periods, affecting the treatment in people with type 2 diabetes. For this population, it is important to quantify changes in physiological and metabolic parameters resulting from the cessation of exercise, since exercise training is a major therapeutic method.

To the best of our knowledge, there is no data concerning the loss of physiological adaptations which occurs after exercise cessation in patients with type 2 diabetes, which have previously trained for a long period of time. The current study evaluated the effects of three months of detraining after nine months of a combined strength and aerobic training program on glycemic control, body composition, peak oxygen consumption (VO2peak) and muscular strength in patients with type 2 diabetes. Further, the investigators examined the extent of the regained adaptations after the resumption of training for a period of nine months.

Tipo de estudio

Intervencionista

Inscripción (Actual)

13

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Komotini, Grecia, 691 00
        • Savvas P. Tokmakidis

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

45 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Type 2 diabetes
  • without micro- and macroangiopathy

Exclusion Criteria:

  • type 1 diabetes
  • cardiovascular disease,
  • confirmed retinopathy/nephropathy/neuropathy,
  • uncontrolled diabetes mellitus (HbA1c>10%).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Lifestyle (exercise training)
Training, detraining and retraining
Thirteen women with type 2 diabetes followed a supervised aerobic and strength training program for 9 months, interrupted for 3 months (detraining) and resumed again for a period of 9 months (retraining).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes from baseline in glycemic control measurements (follow-up for 21 months) at training (9 months), detraining (3 months) and retraining (9 months)
Periodo de tiempo: Changes from baseline in HbA1C, FPG and PPG at training (9 months), detraining (11 months) and retraining (21 months)
Glycemic control was evaluated by the measurement of fasting plasma glucose (FPG), postprandial glucose (PPG) and glycosylated hemoglobin (HbA1C). PPG was calculated by the mean of four values measured at the first week of every period (baseline, 9th, 12th and 21st months).
Changes from baseline in HbA1C, FPG and PPG at training (9 months), detraining (11 months) and retraining (21 months)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Evaluation of body composition
Periodo de tiempo: Changes from baseline in body composition assessment at training (9 months), detraining (3 months), retraining (9 months)
Anthropometric Assessment: Body weight, height, BMI and waist circumference (WC).
Changes from baseline in body composition assessment at training (9 months), detraining (3 months), retraining (9 months)
Peak oxygen consumption (VO2peak)
Periodo de tiempo: Changes from baseline in VO2peak at training (9 months), detraining (11 months) and retraining (21 months)
Measurement of Peak Oxygen Uptake: Patients underwent a symptom-limited graded exercise test on a cycle-ergometer (60 rpm). The initial load was set at 25W and increased gradually by 25W every 2-min until the patients were unable to continue. VO2peak was determined by open-circuit spirometry (E. Jaeger, IEC 601-1, Germany).
Changes from baseline in VO2peak at training (9 months), detraining (11 months) and retraining (21 months)
Measurement of muscular strength in patients with type 2 diabetes
Periodo de tiempo: Changes from baseline in muscular strength at training (9 months), detraining (11 months) and retraining (21 months)
Muscle Strength: Maximum strength was measured with the one-repetition maximum (1 RM) method and total muscle strength was calculated as the sum of leg extension and bench press.
Changes from baseline in muscular strength at training (9 months), detraining (11 months) and retraining (21 months)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Savvas P. Tokmakidis, PhD, Democritus University of Thrace

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2008

Finalización primaria (Actual)

1 de septiembre de 2008

Finalización del estudio (Actual)

1 de junio de 2010

Fechas de registro del estudio

Enviado por primera vez

18 de marzo de 2012

Primero enviado que cumplió con los criterios de control de calidad

18 de abril de 2012

Publicado por primera vez (Estimar)

19 de abril de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

19 de abril de 2012

Última actualización enviada que cumplió con los criterios de control de calidad

18 de abril de 2012

Última verificación

1 de abril de 2012

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • EPEAEK - PYTHAGORAS II
  • 1328-5 PYTHAGORAS II (Otro número de subvención/financiamiento: PYTHAGORAS II; co-financed by Hellenic (25%) and EC (75%))

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. .