- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05115682
Circadian Rhythm and Metabolic Effects of Exercise (HITMet)
Time of Day Specific Glycaemic and Metabolic Response to High-Intensity Interval Training
Descripción general del estudio
Estado
Intervención / Tratamiento
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
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
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:
- Håkan Karlsson, PhD
- Número de teléfono: +46-(0)73-712 14 37
- Correo electrónico: hakan.karlsson.1@ki.se
-
Investigador principal:
- Harriet Wallberg-Henriksson, MD PhD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿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
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Harriet Wallberg-Henriksson, MD PhD, Karolinska Institutet
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (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
- HIT Metabolome
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de 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. .
Ensayos clínicos sobre Diabetes Mellitus, Tipo 2
-
AstraZenecaReclutamiento
-
Daewoong Pharmaceutical Co. LTD.Aún no reclutandoDM2 (Diabetes Mellitus Tipo 2)
-
University of ZambiaUniversity Teaching Hospital, Lusaka, ZambiaAún no reclutandoDiabetes Mellitus Tipo 2 Sin Complicaciones
-
Zhongda HospitalReclutamientoDiabetes mellitus tipo 2 (DM2)Porcelana
-
Newsoara Biopharma Co., Ltd.ReclutamientoDM2 (Diabetes Mellitus Tipo 2)Porcelana
-
Shanghai Golden Leaf MedTec Co. LtdActivo, no reclutandoDiabetes mellitus tipo 2 (DM2)Porcelana
-
Haisco Pharmaceutical Group Co., Ltd.TerminadoDM2 (Diabetes Mellitus Tipo 2)Porcelana
-
PegBio Co., Ltd.TerminadoDiabetes mellitus tipo 2 (DM2)Porcelana
-
Oramed, Ltd.IntegriumTerminadoDM2 (Diabetes Mellitus Tipo 2)Estados Unidos