Ghent University
Ghent, East Flanders, 9000, Belgium
Location status: Recruiting
Location contact
Eline Lievens, Professor
CONTACT
Jeppe Foged Vigh-Larsen, PhD
CONTACT
NCT Number: NCT07678736
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.
Interested in participating?
Request Info20 year–30 year
All sexes
Observational
Ghent, East Flanders, 9000, Belgium
Location status: Recruiting
Eline Lievens, Professor
CONTACT
Jeppe Foged Vigh-Larsen, PhD
CONTACT
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At baseline and at 5-year intervals for up to 20 years
The Matsuda index derived from an oral glucose tolerance test
Time frame: At baseline and at 5-year intervals for up to 20 years
Skeletal muscle fiber type assessed using SDS page
Time frame: At baseline and at 5-year intervals for up to 20 years
Molecular profiling of skeletal muscle tissue, including proteomic and related pathway-level analyses relevant to metabolic function.
Time frame: At baseline and at 5-year intervals for up to 20 years
Whole-body MRI-derived muscle and fat volumes at the total and regional body level
Time frame: At baseline and at 5-year intervals for up to 20 years
Whole-body MRI-derived tissue fat infiltration in the liver, intermuscular and intramuscular area
Time frame: At baseline and at 5-year intervals for up to 20 years
Accelerometer-based physical activity levels
Time frame: At baseline and at 5-year intervals for up to 20 years
Homeostatic Model Assessment of Insulin Resistance based on fasted blood sampling
Time frame: At baseline and at 5-year intervals for up to 20 years
Maximal oxygen uptake assessed using indirect calorimetry during incremental cycling
Time frame: At baseline and at 5-year intervals for up to 20 years
Maximal voluntary isometric contraction torque assessed in a dynamometer
Time frame: At baseline and at 5-year intervals for up to 20 years
Continuous glucose monitoring-derived glycaemic metrics during free-living conditions
Time frame: At baseline and at 5-year intervals for up to 20 years
Dietary intake assessed using repeated 24-hour food diaries and food frequency questionnaires, including estimates of energy intake and macronutrient composition.
Time frame: At baseline and at 5-year intervals for up to 20 years
Proteomics derived measures of adipose tissue phenotype
Time frame: At baseline and at 5-year intervals for up to 20 years
Maximal fat oxidation rate obtained using indirect calorimetry during incremental cycling
Time frame: At baseline and at 5-years intervals for up to 20 years
Carotid-femoral pulsewave velocity measured using Doppler echocardiography with ECG gating
Time frame: At baseline and at 5-year intervals for up to 20 years
Resting heart rate assessed using a chest-worn heart rate monitor
Time frame: At baseline and at 5-year intervals for up to 20 years
Heart rate variability assessed using a chest-worn heart rate monitor
Time frame: At baseline and at 5-year intervals for up to 20 years
Systolic and diastolic blood pressure obtained using a sphygmomanometer
Time frame: At baseline and at 5-year intervals for up to 20 years
Peak and average power output during a 10 s sprint test
Time frame: At baseline and at 5-year intervals for up to 20 years
Lactate accumulation during a 10 s cycling sprint test
Time frame: At baseline and at 5-year intervals for up to 20 years
Including measures of triglycerides, free fatty acids, lipoprotein (a), cholesterol, high-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol
Time frame: At baseline and at 5-year intervals for up to 20 years
Bone density assessed using peripheral quantitative computed tomography (pQCT).
Contact information is provided by the study sponsor or research team.
Eline Lievens, Professor
CONTACT
Jeppe Foged Vigh-Larsen, PhD
CONTACT
University Ghent
Other
The Muscle Phenotype and Cardiometabolic Health Monitoring Project
Acronym: MUSCLE MONITOR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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