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NCT07678736Recruiting

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

The Muscle Phenotype and Cardiometabolic Health Monitoring Project

Source: ClinicalTrials.gov · Last updated 1 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
250 (estimated)
First submitted
12 Feb 2026
Start date
19 May 2025
Primary completion date
31 Dec 2046
Lead sponsor
University Ghent
NCT number
NCT07678736

What you commit to

  • Study type: Observational
  • Planned participants: 250
  • From 19 May 2025 to the primary completion date, 31 Dec 2046
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Daily intake of medication that could confound study outcomes
  • 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

Other illness

  • Chronic disease deemed to affect study outcomes
  • Disease that increase haemorrhage risk
  • 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)

Other

  • Regular smokers
  • Active pregnancy
  • Very high structured physical exercise level (\>10 h/week).

Who the study is looking for

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

Age in the registry: 20 years to 30 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ghent University
Coordinator of this site? Confirm its status
GhentBelgiumRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.