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Circadian Rhythm and Metabolic Effects of Exercise (HITMet)

11 de noviembre de 2021 actualizado por: Harriet Wallberg, Karolinska Institutet

Time of Day Specific Glycaemic and Metabolic Response to High-Intensity Interval Training

Physical exercise is efficacious in controlling blood glucose levels in individuals with Type 2 diabetes. An individual's exercise capacity and ability to utilize glucose as an energy source oscillates throughout the day. Hence, the beneficial effects of exercise on blood glucose levels may depend on the time of day when the exercise bout is performed. However, the time of day in which the most beneficial adaptations to exercise can be achieved remains unknown. This project aims to answer the following questions: Does time of day impact the beneficial effects of exercise on blood glucose? If so, when can the most beneficial effects of exercise be achieved? Which metabolic mechanisms links time of day, exercise and blood glucose control? To address these questions, individuals with or without Type 2 diabetes will perform an exercise session at two different times (09:00 and 16:00), and continuous glucose monitoring will be used to assess the effects of exercise on blood glucose. We will determine the specific metabolic processes which promote the most beneficial blood glucose response. To achieve this, we will measure which metabolic substrates (carbohydrates, lipids and proteins) are used and which metabolites produced in blood, skeletal muscle and adipose tissue in response to exercise at different times of the day.

Descripción general del estudio

Descripción detallada

Exercise has well-established metabolic benefits and is a preferred intervention for Type 2 diabetes prevention and management. Metabolic determinants of exercise such as skeletal muscle and whole-body substrate oxidation capacity, glucose tolerance and insulin sensitivity and adipose tissue fatty acid release all show circadian oscillations. These rhythms may promote substantially different responses depending on the time of day when exercise is performed.

This is an exploratory study aiming to determine whether exercise at specific times of day can amplify the beneficial effects on glycemia and metabolism in twi groups of individuals: those with normal glucose tolerance (NGT) or Type 2 diabetes (n=40 per group). The primary objective is to determine the glycemic response to an exercise bout at two distinct times of day, measured by continuous glucose monitoring, in men and women with NGT or Type 2 diabetes. The secondary aim is to identify specific metabolites which facilitate the strongest glycemic response to exercise by examining the whole-body and peripheral tissue metabolomic response to an exercise bout.

The primary goal of the study is to examine the glycemic and metabolic response to exercise within-group for participants with NGT or Type 2 diabetes. Further comparisons will be made between groups with NGT or Type 2 diabetes, across sexes, and by individual chronotype (determined by a standardized questionnaire) to examine the variation in the exercise response across these parameters.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

80

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.

Estudio Contacto

  • Nombre: Harriet Wallberg-Henriksson, MD PhD
  • Número de teléfono: +46-(0)70-629 64 70
  • Correo electrónico: harriet.wallberg@ki.se

Ubicaciones de estudio

      • Stockholm, Suecia, 17070
        • Reclutamiento
        • Karolinska Institutet
        • Contacto:
        • Investigador principal:
          • Harriet Wallberg-Henriksson, MD PhD

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 68 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Body Mass Index (BMI): 23 - 33 kg/m2
  • Participants diagnosed with Type 2 Diabetes (insulin independent) or Normal Glucose Tolerant (2h oral glucose tolerance test within normal range).
  • Ability to provide informed consent
  • Ability to complete the exercise regiment

Exclusion Criteria:

  • Medications: Insulin
  • Current nicotine user (cigarettes, snus, nicotine gum) or past nicotine users less than 6 months before inclusion in the study
  • Pre-existing cardiovascular condition (Angina pectoris, Cardiac arrhythmia, Cardiac infarction, Coronary stent / angiography, Cerebrovascular insult, Hypertension [> 160 mmHg systolic, or > 95 mmHg diastolic])
  • Pre-existing blood-borne disease (HIV, Hepatitis C, MRSA)
  • Pre-existing systemic or localized rheumatic illness
  • Malignant Disease
  • Pre-existing psychiatric disorder
  • Another pre-existing systemic disease

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: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Morning First
Participants will complete a single bout of exercise at 09:00, and after at least a one-week washout perform another exercise bout at 16:00.
The participants will perform a low-volume, High-intensity Intermittent Exercise bout on a cycle ergometer. Peak exercise capacity of the study participants will be determined on a separate occasion using a ramp-up maximal oxygen consumption test (VO2peak). A single exercise bout will consist of a 7-minute warm-up on a cycle ergometer, followed by 6 1-minute intervals of cycling at individual maximal capacity and 75rpm (rotations per minute). These intervals will be interspersed with 1-min breaks of cycling at low resistance and 75rpm, and the session will conclude with a 3-minute cool-down interval (20 minutes in total).
Experimental: Afternoon First
Participants will complete a single bout of exercise at 16:00, and after at least a one-week washout perform another exercise bout at 09:00.
The participants will perform a low-volume, High-intensity Intermittent Exercise bout on a cycle ergometer. Peak exercise capacity of the study participants will be determined on a separate occasion using a ramp-up maximal oxygen consumption test (VO2peak). A single exercise bout will consist of a 7-minute warm-up on a cycle ergometer, followed by 6 1-minute intervals of cycling at individual maximal capacity and 75rpm (rotations per minute). These intervals will be interspersed with 1-min breaks of cycling at low resistance and 75rpm, and the session will conclude with a 3-minute cool-down interval (20 minutes in total).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Exercise-induced Changes in 24 Hour Interstitial Glucose Concentration
Periodo de tiempo: 3 days (1 day before to 1 day after exercise)
Glucose excursions will be charted using continuous interstitial glucose monitors. The day immediately before exercise will be used as baseline, the day of exercise to assess the acute response, and the day after exercise to assess lasting effects on glycemia. Exercise effects on glucose concentration will be primarily assessed by comparing 24-hour curves between conditions.
3 days (1 day before to 1 day after exercise)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Acute Exercise-induced Changes in Interstitial Glucose Concentration
Periodo de tiempo: 2 hours (0 minutes before to 120 minutes after exercise)
Glucose will be charted using continuous glucose monitors. Acute response to exercise, during the exercise bout and during an additional 120 minutes will be compared between conditions.
2 hours (0 minutes before to 120 minutes after exercise)
Interstitial Glucose Concentration Response to a Meal
Periodo de tiempo: 2 days (1 day before and day of exercise)
Glucose will be charted using continuous glucose monitors. Three standardized meals per day will be provided on each occasion for the day before, day of and day after exercise. The 120 minute glucose response to the standardized meal succeeding an exercise bout will be compared to the same meal on a baseline (no exercise) day and between the two exercise times.
2 days (1 day before and day of exercise)
Interstitial Glucose Concentration Variability
Periodo de tiempo: 3 days (1 day before to 1 day after exercise)
Glucose will be charted using continuous glucose monitors. The day immediately before exercise will be used as baseline, the day of exercise to assess the acute response, and the day after exercise to assess lasting effects on glucose concentration variability.
3 days (1 day before to 1 day after exercise)
Time Spent in Interstitial Glucose Concentration Range
Periodo de tiempo: 3 days (1 day before to 1 day after exercise)
Glucose will be charted using continuous glucose monitors. The day immediately before exercise will be used as baseline, the day of exercise to assess the acute response, and the day after exercise to assess lasting effects on glycemic variability. Daily time spent in low (<3.9mmol/L), high (>10mmol/L) and within target glycemic range (3.9-10mmol/L) will be calculated on each occasion.
3 days (1 day before to 1 day after exercise)
Nocturnal Interestitial Glucose Concentration
Periodo de tiempo: 2 days (day of, and 1 day after exercise)
Glucose will be charted using continuous glucose monitors. The day immediately before exercise will be used as baseline, the day of exercise to assess the acute response, and the day after exercise to assess lasting effects on glycemic variability. Nocturnal glycemia (00:00-06:00) for each day will be compared on each exercise occasion.
2 days (day of, and 1 day after exercise)
Metabolic Response to Exercise
Periodo de tiempo: 1 hour (5 minutes before, 5 minutes after and 60 minutes after exercise)
Changes in blood, skeletal muscle and subcutaneous adipose tissue metabolite levels will be assessed by broad-spectrum, untargeted metabolomics. Samples will be collected immediately before (-5 minutes) and after (+5 minutes) each exercise bout. An additional blood sample will be collected one hour after exercise completion (+60 minutes).
1 hour (5 minutes before, 5 minutes after and 60 minutes after exercise)

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Harriet Wallberg-Henriksson, MD PhD, Karolinska Institutet

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 (Actual)

10 de noviembre de 2021

Finalización primaria (Anticipado)

1 de noviembre de 2023

Finalización del estudio (Anticipado)

1 de noviembre de 2023

Fechas de registro del estudio

Enviado por primera vez

19 de octubre de 2021

Primero enviado que cumplió con los criterios de control de calidad

1 de noviembre de 2021

Publicado por primera vez (Actual)

10 de noviembre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de noviembre de 2021

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

11 de noviembre de 2021

Última verificación

1 de noviembre de 2021

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

Individual participant data underlying results reported in a publication will be shared after deidentification.

Marco de tiempo para compartir IPD

Data will be made available indefinetly after publication.

Criterios de acceso compartido de IPD

Data will be available for any purpose.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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 2

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