Insulin ResistanceMUSCLE MONITORNCT07678736
The Muscle Monitor: Early Skeletal Muscle Indicators of Insulin Resistance and Cardiometabolic Risk
An observational study of Insulin Resistance and Insulin Resistance and Type 2 Diabetes, run by University Ghent at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 30 years
- Conditions the study is for
- Insulin Resistance, Insulin Resistance and Type 2 Diabetes, Cardiometabolic Risk Factors
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 19 May 2025to 31 Dec 2046
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Adult
Study population: Participants will be recruited from the greater Ghent area (Belgium) using recruitment materials including posters mounted on relevant locations (e.g. educational sites) and circulated on social media (e.g. Facebook, Linkedin, Twitter). The Gent University volunteer register of people who have expressed interest in participating in research studies will also be used.
Who may be able to join
- Sex: Males and females
- Age: 20-30 years
- BMI <35
- Healthy (no diagnosed chronic disease)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University
Ghent, East Flanders, 9000
Eline Lievens, Professor, 00320478312585, eline.lievens@ugent.be
Jeppe Foged Vigh-Larsen, PhD, jeppefoged.vighlarsen@ugent.be
About this study
Official title: 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).
Read more
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.
Read the detailed description
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.
- Conditions
- Insulin Resistance, Insulin Resistance and Type 2 Diabetes, Cardiometabolic Risk Factors, Physical Activity, Muscle Fiber Type
- Keywords
- Insulin sensitivity, Skeletal muscle, Physical activity
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body insulin sensitivity
The Matsuda index derived from an oral glucose tolerance test
Measured: At baseline and at 5-year intervals for up to 20 years
Secondary outcomes (15)
Skeletal muscle fiber type
Skeletal muscle fiber type assessed using SDS page
Measured: At baseline and at 5-year intervals for up to 20 years
Molecular skeletal muscle profile
Molecular profiling of skeletal muscle tissue, including proteomic and related pathway-level analyses relevant to metabolic function.
Measured: At baseline and at 5-year intervals for up to 20 years
MRI-derived muscle and fat volumes
Whole-body MRI-derived muscle and fat volumes at the total and regional body level
Measured: At baseline and at 5-year intervals for up to 20 years
MRI derived tissue fat infiltration
Whole-body MRI-derived tissue fat infiltration in the liver, intermuscular and intramuscular area
Measured: At baseline and at 5-year intervals for up to 20 years
Physical activity level
Accelerometer-based physical activity levels
Measured: At baseline and at 5-year intervals for up to 20 years
HOMA-IR
Homeostatic Model Assessment of Insulin Resistance based on fasted blood sampling
Measured: At baseline and at 5-year intervals for up to 20 years
Cardiorespiratory fitness
Maximal oxygen uptake assessed using indirect calorimetry during incremental cycling
Measured: At baseline and at 5-year intervals for up to 20 years
Muscle strength
Maximal voluntary isometric contraction torque assessed in a dynamometer
Measured: At baseline and at 5-year intervals for up to 20 years
Free-living glycaemic control
Continuous glucose monitoring-derived glycaemic metrics during free-living conditions
Measured: At baseline and at 5-year intervals for up to 20 years
Dietary intake
Dietary intake assessed using repeated 24-hour food diaries and food frequency questionnaires, including estimates of energy intake and macronutrient composition.
Measured: At baseline and at 5-year intervals for up to 20 years
Subcutaneous adipose tissue phenotyping
Proteomics derived measures of adipose tissue phenotype
Measured: At baseline and at 5-year intervals for up to 20 years
Maximal fat oxidation rate
Maximal fat oxidation rate obtained using indirect calorimetry during incremental cycling
Measured: At baseline and at 5-year intervals for up to 20 years
Pulsewave velocity
Carotid-femoral pulsewave velocity measured using Doppler echocardiography with ECG gating
Measured: At baseline and at 5-years intervals for up to 20 years
Resting heart rate
Resting heart rate assessed using a chest-worn heart rate monitor
Measured: At baseline and at 5-year intervals for up to 20 years
Heart rate variability
Heart rate variability assessed using a chest-worn heart rate monitor
Measured: At baseline and at 5-year intervals for up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start19 May 2025
- Primary completion31 Dec 2046 (estimated)
- Study completion31 Dec 2046 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678736
- Sponsor's protocol ID
- ONZ-2024-0588
- Acronym
- MUSCLE MONITOR
- Status last verified
- Jun 2026
- First submitted
- 12 Feb 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Muscle Phenotype and Cardiometabolic Health Monitoring Project
- ClinicalTrials.gov ID
- NCT07678736
- Acronym / sponsor ID
- MUSCLE MONITOR / ONZ-2024-0588
- Conditions
- Insulin Resistance, Insulin Resistance and Type 2 Diabetes, Cardiometabolic Risk Factors, Physical Activity, Muscle Fiber Type
- Keywords
- Insulin sensitivity, Skeletal muscle, Physical activity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent
- Study start
- 19 May 2025 (actual)
- Primary completion
- 31 Dec 2046 (estimated)
- Study completion
- 31 Dec 2046 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Age groups
- Adult
- Study population
- Participants will be recruited from the greater Ghent area (Belgium) using recruitment materials including posters mounted on relevant locations (e.g. educational sites) and circulated on social media (e.g. Facebook, Linkedin, Twitter). The Gent University volunteer register of people who have expressed interest in participating in research studies will also be used.
Key inclusion criteria (4 listed)
- Sex: Males and females
- Age: 20-30 years
- BMI <35
- Healthy (no diagnosed chronic disease)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Whole-body insulin sensitivity
Time frame: At baseline and at 5-year intervals for up to 20 years
The Matsuda index derived from an oral glucose tolerance test
15 secondary outcomes
Skeletal muscle fiber type
Time frame: At baseline and at 5-year intervals for up to 20 years
Molecular skeletal muscle profile
Time frame: At baseline and at 5-year intervals for up to 20 years
MRI-derived muscle and fat volumes
Time frame: At baseline and at 5-year intervals for up to 20 years
MRI derived tissue fat infiltration
Time frame: At baseline and at 5-year intervals for up to 20 years
Physical activity level
Time frame: At baseline and at 5-year intervals for up to 20 years
HOMA-IR
Time frame: At baseline and at 5-year intervals for up to 20 years
Cardiorespiratory fitness
Time frame: At baseline and at 5-year intervals for up to 20 years
Muscle strength
Time frame: At baseline and at 5-year intervals for up to 20 years
Free-living glycaemic control
Time frame: At baseline and at 5-year intervals for up to 20 years
Dietary intake
Time frame: At baseline and at 5-year intervals for up to 20 years
Subcutaneous adipose tissue phenotyping
Time frame: At baseline and at 5-year intervals for up to 20 years
Maximal fat oxidation rate
Time frame: At baseline and at 5-year intervals for up to 20 years
Pulsewave velocity
Time frame: At baseline and at 5-years intervals for up to 20 years
Resting heart rate
Time frame: At baseline and at 5-year intervals for up to 20 years
Heart rate variability
Time frame: At baseline and at 5-year intervals for up to 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
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Effects of Meal Macronutrients on Postprandial Lipids
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Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance and Insulin Resistance and Type 2 Diabetes, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eline Lievens, Professor (00320478312585, eline.lievens@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole-body insulin sensitivity (time frame: At baseline and at 5-year intervals for up to 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.