The Muscle Monitor: Early Skeletal Muscle Indicators of Insulin Resistance and Cardiometabolic Risk (MUSCLE MONITOR)
The Muscle Phenotype and Cardiometabolic Health Monitoring Project
Insulin resistance is an early etiological factor in the development of type-2 diabetes (T2D), which constitutes a large societal health burden with an expected additional rise in the years to come.
Skeletal muscle is the body's largest lean tissue mass and the major site of glucose disposal in response to insulin stimulation. Prior studies have suggested that a fast skeletal muscle phenotype, including a predominant fast muscle fiber composition, reduced capillary density, low fat oxidation and muscle oxidative capacity may be implicated in insulin resistance and TD2 development. However, key questions pertain in relation to the cause and effect of these relationships as well as the interaction with potential confounders and effect-modifiers including life-style factors (e.g. diet and physical activity levels) and general participant characteristics (e.g. body composition and training status).
In the present project, we therefore aim to derive muscle fiber type and extensively map the proteomic signature of the early stages of insulin resistance in a large cross-sectional study using a young and apparently healthy cohort prior to T2D development, including a thorough participant characterization. We will recruit ~250 participants (men and women) in the age of 20-30 years and conduct extensive phenotyping and tissue sampling across one laboratory-based test day and a scan visit, as well as measurements of physical activity level and glucose handling in free-living conditions with wearable sensors.
The study has a longitudinal aspect as participants will be re-invited at 5-year intervals for up to 20 years to delineate the trajectory of metabolic health in relation to muscle phenotype measures.
The results of the project are expected to lead to significant advancements in our understanding of the importance of muscle phenotype for early-stage insulin resistance and metabolic health trajectories. Such understanding has potentially important clinical implications, as it can open new avenues for targeted interventions and individualized early preventive strategies to counter or delay the progression of insulin resistance and associated metabolic and cardiovascular disorders.
Descripción general del estudio
Estado
Descripción detallada
The project is composed of 1) a screening visit to determine study eligibility, 2) a main test day in the lab, 3) 10 days of physical activity tracking and continuous glucose monitoring in free-living conditions and 4) a scan visit including a whole-body MRI scan and lower leg pQCT scan.
For the main lab visit the participants will arrive in the morning after an overnight fast. This visit includes measurements of anthropometrics, resting metabolic rate, resting heart rate + heart rate variability, arterial stiffness, intima media thickness, as well as blood pressure obtained in the supine position. In addition, a fasting blood sample will be obtained followed by a 2-h glucose tolerance test with concomitant questionnaires provided in writing on basic demographics, physical activity level, sleep, stress and mental health. Two thigh muscle biopsies and a subcutaneous adipose tissue fat sample from the abdominal region will be obtained, while maximal voluntary knee-extensor contraction torque and rate of force development will be measured. Lastly, cycling-based assessments of maximal fat oxidation rate, peak power and maximal oxygen uptake will be assessed using indirect calorimetry including capillary lactate samples.
The scan visit will consist of an MRI whole-body scan, soleus and gastrocnemius 1H-MRS and a pQCT bone scan of the lower limb at 4% and 66% of the total bone length.
The objective measurements of physical activity levels and glucose-handling capacity will be performed for 10 days in free-living conditions using feasibly worn sensors (continuous glucose monitor and thigh-worn accelerometer). During this time, a food dairy needs to be filled in during two week days and one weekend day to estimate the habitual food intake.
A standardized evening meal will be provided prior to the laboratory-based test day and a standardized lunch meal served during the testing day.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Eline Lievens, Professor
- Número de teléfono: 00320478312585
- Correo electrónico: eline.lievens@ugent.be
Copia de seguridad de contactos de estudio
- Nombre: Jeppe Foged Vigh-Larsen, PhD
- Número de teléfono: 004529870635
- Correo electrónico: jeppefoged.vighlarsen@ugent.be
Ubicaciones de estudio
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East Flanders
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Ghent, East Flanders, Bélgica, 9000
- Reclutamiento
- Ghent University
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Contacto:
- Eline Lievens, Professor
- Número de teléfono: 00320478312585
- Correo electrónico: eline.lievens@ugent.be
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Contacto:
- Jeppe Foged Vigh-Larsen, PhD
- Correo electrónico: jeppefoged.vighlarsen@ugent.be
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Sex: Males and females
- Age: 20-30 years
- BMI <35
- Healthy (no diagnosed chronic disease)
Exclusion Criteria:
- Chronic disease deemed to affect study outcomes
- Disease that increase haemorrhage risk
- Daily intake of medication that could confound study outcomes
- Regular smokers
- Active pregnancy
- Immobilization (inactivity due to injury or illness, e.g. cast or brace) for more than a week in the month prior to the study or for more than 4 weeks in the past 6 months prior to the study
- Very high structured physical exercise level (>10 h/week).
- Participants not willing to adhere to standardized meal prescriptions included in the study protocols will also be excluded (due to e.g. allergies or specific dietary preferences)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Whole-body insulin sensitivity
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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The Matsuda index derived from an oral glucose tolerance test
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At baseline and at 5-year intervals for up to 20 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Skeletal muscle fiber type
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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Skeletal muscle fiber type assessed using SDS page
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At baseline and at 5-year intervals for up to 20 years
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Molecular skeletal muscle profile
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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Molecular profiling of skeletal muscle tissue, including proteomic and related pathway-level analyses relevant to metabolic function.
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At baseline and at 5-year intervals for up to 20 years
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MRI-derived muscle and fat volumes
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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Whole-body MRI-derived muscle and fat volumes at the total and regional body level
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At baseline and at 5-year intervals for up to 20 years
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MRI derived tissue fat infiltration
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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Whole-body MRI-derived tissue fat infiltration in the liver, intermuscular and intramuscular area
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At baseline and at 5-year intervals for up to 20 years
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Physical activity level
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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Accelerometer-based physical activity levels
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At baseline and at 5-year intervals for up to 20 years
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HOMA-IR
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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Homeostatic Model Assessment of Insulin Resistance based on fasted blood sampling
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At baseline and at 5-year intervals for up to 20 years
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Cardiorespiratory fitness
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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Maximal oxygen uptake assessed using indirect calorimetry during incremental cycling
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At baseline and at 5-year intervals for up to 20 years
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Muscle strength
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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Maximal voluntary isometric contraction torque assessed in a dynamometer
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At baseline and at 5-year intervals for up to 20 years
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Free-living glycaemic control
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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Continuous glucose monitoring-derived glycaemic metrics during free-living conditions
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At baseline and at 5-year intervals for up to 20 years
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Dietary intake
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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Dietary intake assessed using repeated 24-hour food diaries and food frequency questionnaires, including estimates of energy intake and macronutrient composition.
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At baseline and at 5-year intervals for up to 20 years
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Subcutaneous adipose tissue phenotyping
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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Proteomics derived measures of adipose tissue phenotype
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At baseline and at 5-year intervals for up to 20 years
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Maximal fat oxidation rate
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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Maximal fat oxidation rate obtained using indirect calorimetry during incremental cycling
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At baseline and at 5-year intervals for up to 20 years
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Pulsewave velocity
Periodo de tiempo: At baseline and at 5-years intervals for up to 20 years
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Carotid-femoral pulsewave velocity measured using Doppler echocardiography with ECG gating
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At baseline and at 5-years intervals for up to 20 years
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Resting heart rate
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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Resting heart rate assessed using a chest-worn heart rate monitor
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At baseline and at 5-year intervals for up to 20 years
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Heart rate variability
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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Heart rate variability assessed using a chest-worn heart rate monitor
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At baseline and at 5-year intervals for up to 20 years
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Blood pressure
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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Systolic and diastolic blood pressure obtained using a sphygmomanometer
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At baseline and at 5-year intervals for up to 20 years
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10 s sprint peak and average power
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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Peak and average power output during a 10 s sprint test
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At baseline and at 5-year intervals for up to 20 years
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Lactate accumulation
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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Lactate accumulation during a 10 s cycling sprint test
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At baseline and at 5-year intervals for up to 20 years
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Blood lipid profile
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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Including measures of triglycerides, free fatty acids, lipoprotein (a), cholesterol, high-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol
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At baseline and at 5-year intervals for up to 20 years
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Bone measurements
Periodo de tiempo: At baseline and at 5-year intervals for up to 20 years
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Bone density assessed using peripheral quantitative computed tomography (pQCT).
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At baseline and at 5-year intervals for up to 20 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- ONZ-2024-0588
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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