- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03730727
Exercise-meal Timing and Postprandial Glucose Control
Maximizing Postprandial Glycaemic Control: When is the Right Time for Physical Activity
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Healthy volunteers will undergo an informed consent and screening visit to determine their eligibility. Participants who are included will then be assigned to one of the three studies (walking, standing, or circuit-exercises) and then come to the lab on 5 consecutive mornings to undergo a pre-trial visit and 4 experimental trial visits (A, B, C, and D). The order of the experimental trial visits will be randomized in a counter-balanced, cross-over design.
Screening visit: Having read the participant info sheet, a study investigator will discuss the project with the potential participant who will have the chance to ask any questions. Informed consent will be sought and a General Health and Physical Activity Questionnaire will be completed. Body weight, height, resting heart rate, blood pressure, and waist circumference will be measured, and blood measures of glycated hemoglobin, triglycerides, and cholesterol will be taken.
Pre-trials visit: Participants will come to the laboratory to receive an accelerometer physical activity monitor, a continuous glucose monitor, and to complete a physical activity bout (walking, standing, or stair climbing, depending on which study they are enrolled). Over the next 5 consecutive days, participants will be instructed to maintain their normal diet and activity habits, to record their dietary intake, to refrain from vigorous exercise and alcohol, and continue wearing the accelerometer and continuous glucose monitoring devices at all times.
Experimental trial A: Following an 8-10 hour overnight fast, participants will come to the lab and will be given a 500 calorie meal-replacement drink to consume within 10 minutes. They will remain in a seated position for 2 hours and then complete the physical activity bout (30-min walk, 30-min stand, or 10-min circuit-exercises) after which they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.
Experimental trial B: Following an 8-10 hour overnight fast, participants will come to the lab and complete the physical activity bout. Immediately after this they will be given a 500 calorie meal-replacement drink to consume within 10 minutes and will remain in a seated position for 2 hours, after which they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.
Experimental trial C: Following an 8-10 hour overnight fast, participants will come to the lab and will be given a 500 calorie meal-replacement drink to consume within 10 minutes. Immediately after finishing the meal they will complete the physical activity bout and then remain in a seated position until 2-hours has passed since ingesting the meal. After this time they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.
Experimental trial D: Following an 8-10 hour overnight fast, participants will come to the lab and will be given a 500 calorie meal-replacement drink to consume within 10 minutes. Thirty minutes after finishing the meal they will complete the physical activity bout and then remain in a seated position until 2-hours has passed since ingesting the meal. After this time they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.
After the final trial, the accelerometer and continuous glucose monitoring devices will be collected and the participant's role in the study will end.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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West Midlands
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Edgbaston, West Midlands, Reino Unido, B15 2TT
- University of Birmingham
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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:
- Age 18-65 years.
- Body Mass Index 18-30 kg/m2.
- Generally healthy.
Exclusion Criteria:
- Smoking.
- Pregnancy, or planning to become pregnant, or a nursing mother.
- More than 2 kg weight change during the last month.
- Diabetes.
- Evidence of, or being treated for, cancer or infectious/non-infectious chronic hematological, pulmonary, cardiac, hepatic, renal, or gastrointestinal diseases.
- Any contraindication to exercise
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Control
A liquid meal replacement shake containing 500 kcal (55% kcals from carb, 30% fat, 15% protein) will be administered at approx.
8 am following an 8-10 hour overnight fast.
Postprandial blood glucose responses will be assessed for 2-hours post-ingestion.
Two-hours after ingestion of the meal, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises [10 squats, 10 push-ups, 10 lunges, 10 sit-ups]).
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Physical activity will consist of either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises (10 squats, 10 push-ups, 10 lunges, 10 sit-ups).
Liquid meal replacement shake containing 500 kcal, with 55% kcals from carb, 30% from fat, and 15% from protein.
|
Experimental: Immediate prior to meal
At approx.
8 am following an 8-10 hour overnight fast, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises [10 squats, 10 push-ups, 10 lunges, 10 sit-ups]).
Immediately after completion of this bout, a liquid meal replacement shake containing 500 kcal will be administered.
Postprandial blood glucose responses will be assessed for 2-hours post-ingestion.
|
Physical activity will consist of either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises (10 squats, 10 push-ups, 10 lunges, 10 sit-ups).
Liquid meal replacement shake containing 500 kcal, with 55% kcals from carb, 30% from fat, and 15% from protein.
|
Experimental: Immediate post-meal
A liquid meal replacement shake containing 500 kcal will be administered at approx.
8 am following an 8-10 hour overnight fast.
Postprandial blood glucose responses will be assessed for 2-hours post-ingestion.
Immediately after ingestion of the meal, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises [10 squats, 10 push-ups, 10 lunges, 10 sit-ups]).
|
Physical activity will consist of either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises (10 squats, 10 push-ups, 10 lunges, 10 sit-ups).
Liquid meal replacement shake containing 500 kcal, with 55% kcals from carb, 30% from fat, and 15% from protein.
|
Experimental: 30-minutes post-meal
A liquid meal replacement shake containing 500 kcal will be administered at approx.
8 am following an 8-10 hour overnight fast.
Postprandial blood glucose responses will be assessed for 2-hours post-ingestion.
Thirty-minutes after ingestion of the meal, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self selected brisk pace on a treadmill, or 3-sets of circuit-exercises [10 squats, 10 push-ups, 10 lunges, 10 sit-ups]).
|
Physical activity will consist of either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises (10 squats, 10 push-ups, 10 lunges, 10 sit-ups).
Liquid meal replacement shake containing 500 kcal, with 55% kcals from carb, 30% from fat, and 15% from protein.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Postprandial blood glucose concentrations.
Periodo de tiempo: In all trials, postprandial blood glucose concentrations will be measured - the change from baseline (immediately prior to meal ingestion) 2-hours after meal ingestion.
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Continuous glucose monitoring (CGM; Dexcom G5 Mobile) will be used to measure the change in glucose levels from baseline.
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In all trials, postprandial blood glucose concentrations will be measured - the change from baseline (immediately prior to meal ingestion) 2-hours after meal ingestion.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Postprandial blood glucose control (mean).
Periodo de tiempo: In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
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Mean glucose levels will be derived from CGM-measurements.
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In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
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Postprandial blood glucose control (standard deviation).
Periodo de tiempo: In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
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The standard deviation of glucose levels will be derived from CGM-measurements.
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In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
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Postprandial blood glucose control.
Periodo de tiempo: In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
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The mean amplitude of glycemic excursions will be derived from CGM-measurements.
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In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
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
- ERN_18-0942
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .
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