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RecruitingNCT07678736MUSCLE MONITORUpdated Jul 1, 2026

The Muscle Monitor: Early Skeletal Muscle Indicators of Insulin Resistance and Cardiometabolic Risk

An observational study in Insulin Resistance, Insulin Resistance and Type 2 Diabetes and Cardiometabolic Risk Factors, sponsored by University Ghent. Recruiting at 1 site in Belgium. Open to participants aged 20 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by University Ghent · Observational

From the registry’s dates

  • Started May 2025; still recruiting 1 year 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
20 Years to 30 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Insulin Resistance with a site in Belgium — 3 open to participants now, 4 under way, none of them phase 3. Insulin Resistance · Belgium.

Started
2025
the only one that year
Observational
8 of 22
3 open now
Registered
22nd of 22
by date

Among the 22 studies in Insulin Resistance with a site in Belgium, this one is the only one that started in 2025, is one of 8 observational ones, and was the 22nd registered.

By phase

22 studies; the count open now beside each. This study's row is marked.

No phase8 · 0 open
Observationalthis study8 · 3 open
Phase 23 · 0 open
Phase 43 · 0 open

By the year they started

First in 2002; this study’s year is marked. 1 started in 2025.

Size and results

Median enrollment 47 across the 14 interventional studies, 163 across the 8 observational. Of the 15 that completed or were terminated, 2 (13%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 22 studies in Insulin Resistance with a site in Belgium, or all of them as a file.
02

Study 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.

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.

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.

03

Conditions studied

  • Insulin Resistance
  • Insulin Resistance and Type 2 Diabetes
  • Cardiometabolic Risk Factors
  • Physical Activity
  • Muscle Fiber Type

Keywords

  • Insulin sensitivity
  • Skeletal muscle
  • Physical activity
04

Who can participate

Ages eligible
20 Years to 30 Years
Sexes eligible
All
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Sex: Males and females
  • Age: 20-30 years
  • \<35
  • Healthy (no diagnosed chronic disease)

Exclusion criteria

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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Whole-body insulin sensitivity

    The Matsuda index derived from an oral glucose tolerance test

    Time frame: At baseline and at 5-year intervals for up to 20 years

Secondary outcomes

  1. Skeletal muscle fiber type

    Skeletal muscle fiber type assessed using SDS page

    Time frame: At baseline and at 5-year intervals for up to 20 years

  2. Molecular skeletal muscle profile

    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

  3. MRI-derived muscle and fat volumes

    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

  4. MRI derived tissue fat infiltration

    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

  5. Physical activity level

    Accelerometer-based physical activity levels

    Time frame: At baseline and at 5-year intervals for up to 20 years

  6. HOMA-IR

    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

  7. Cardiorespiratory fitness

    Maximal oxygen uptake assessed using indirect calorimetry during incremental cycling

    Time frame: At baseline and at 5-year intervals for up to 20 years

  8. Muscle strength

    Maximal voluntary isometric contraction torque assessed in a dynamometer

    Time frame: At baseline and at 5-year intervals for up to 20 years

  9. Free-living glycaemic control

    Continuous glucose monitoring-derived glycaemic metrics during free-living conditions

    Time frame: At baseline and at 5-year intervals for up to 20 years

  10. Dietary intake

    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

  11. Subcutaneous adipose tissue phenotyping

    Proteomics derived measures of adipose tissue phenotype

    Time frame: At baseline and at 5-year intervals for up to 20 years

  12. Maximal fat oxidation rate

    Maximal fat oxidation rate obtained using indirect calorimetry during incremental cycling

    Time frame: At baseline and at 5-year intervals for up to 20 years

  13. Pulsewave velocity

    Carotid-femoral pulsewave velocity measured using Doppler echocardiography with ECG gating

    Time frame: At baseline and at 5-years intervals for up to 20 years

  14. Resting heart rate

    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

  15. Heart rate variability

    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

Other outcomes

  1. Blood pressure

    Systolic and diastolic blood pressure obtained using a sphygmomanometer

    Time frame: At baseline and at 5-year intervals for up to 20 years

  2. 10 s sprint peak and average power

    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

  3. Lactate accumulation

    Lactate accumulation during a 10 s cycling sprint test

    Time frame: At baseline and at 5-year intervals for up to 20 years

  4. Blood lipid profile

    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

  5. Bone measurements

    Bone density assessed using peripheral quantitative computed tomography (pQCT).

    Time frame: At baseline and at 5-year intervals for up to 20 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2025 (actual). Primary completion is estimated for Dec 2046, 259 months after the start.

Of 130 non-industry observational studies under Insulin Resistance, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 142. This study's planned 259 months is above that.

Counting every sponsor, half of 133 studies reached it within 53 months; a quarter within 18 and three quarters within 143.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2026
First posted
Jul 1, 2026
StartActual
May 19, 2025
Primary completionEst.
Dec 31, 2046
CompletionEst.
Dec 31, 2046
Last update
Jul 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07678736
Lead sponsor
University Ghent
Responsible party
Sponsor
First posted
Jul 1, 2026
Start date
May 19, 2025
Primary completion
Dec 31, 2046 (estimated)
Completion
Dec 31, 2046 (estimated)
Last update
Jul 1, 2026

Study contacts

Eline Lievens, Professor
Contact
eline.lievens@ugent.be
00320478312585
Jeppe Foged Vigh-Larsen, PhD
Contact
jeppefoged.vighlarsen@ugent.be
004529870635

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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