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

NCT07678736 | Recruiting

• 1 other identifier: ONZ-2024-0588
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Insulin sensitivity; Skeletal muscle; Physical activity

Outcome Measures

Primary Outcomes (1)

• Whole-body insulin sensitivity

  The Matsuda index derived from an oral glucose tolerance test

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

Secondary Outcomes (15)

• Skeletal muscle fiber type

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

• Molecular skeletal muscle profile

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

• MRI-derived muscle and fat volumes

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

• MRI derived tissue fat infiltration

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

• Physical activity level

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

Other Outcomes (5)

• Blood pressure

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

• 10 s sprint peak and average power

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

• Lactate accumulation

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

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Ghent: lead
• University Hospital, Ghent: collaborator

Study Sites (1)

Ghent University

Ghent, East Flanders, 9000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Two skeletal thigh muscle biopsies (one snap-frozen in liquid nitrogen and one embedded in Tissue-Tek), one subcutaneous adipose tissue sample (snap-frozen in liquid nitrogen) and blood samples obtained in the fasted state (whole blood, EDTA plasma, fluoride plasma and serum), as well as during a 7-point oral glucose tolerance test (fluoride plasma and serum), will be stored for at -80 degree C in a biobank. Whole blood is stored for genetic analyses.

MeSH Terms

Conditions

Insulin Resistance; Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Behavior

Central Study Contacts

Eline Lievens, Professor

CONTACT

00320478312585; eline.lievens@ugent.be

Jeppe Foged Vigh-Larsen, PhD

CONTACT

004529870635; jeppefoged.vighlarsen@ugent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: July 1, 2026
• Study Start: May 19, 2025
• Primary Completion (Estimated): December 31, 2046
• Study Completion (Estimated): December 31, 2046
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)