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The Muscle Monitor: Early Skeletal Muscle Indicators of Insulin Resistance and Cardiometabolic Risk (MUSCLE MONITOR)

24 de junho de 2026 atualizado por: University Ghent

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).

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.

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

250

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

N/D

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

Inclusion Criteria:

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

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)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Whole-body insulin sensitivity
Prazo: At baseline and at 5-year intervals for up to 20 years
The Matsuda index derived from an oral glucose tolerance test
At baseline and at 5-year intervals for up to 20 years

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Skeletal muscle fiber type
Prazo: At baseline and at 5-year intervals for up to 20 years
Skeletal muscle fiber type assessed using SDS page
At baseline and at 5-year intervals for up to 20 years
Molecular skeletal muscle profile
Prazo: 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.
At baseline and at 5-year intervals for up to 20 years
MRI-derived muscle and fat volumes
Prazo: 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
At baseline and at 5-year intervals for up to 20 years
MRI derived tissue fat infiltration
Prazo: 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
At baseline and at 5-year intervals for up to 20 years
Physical activity level
Prazo: At baseline and at 5-year intervals for up to 20 years
Accelerometer-based physical activity levels
At baseline and at 5-year intervals for up to 20 years
HOMA-IR
Prazo: At baseline and at 5-year intervals for up to 20 years
Homeostatic Model Assessment of Insulin Resistance based on fasted blood sampling
At baseline and at 5-year intervals for up to 20 years
Cardiorespiratory fitness
Prazo: At baseline and at 5-year intervals for up to 20 years
Maximal oxygen uptake assessed using indirect calorimetry during incremental cycling
At baseline and at 5-year intervals for up to 20 years
Muscle strength
Prazo: At baseline and at 5-year intervals for up to 20 years
Maximal voluntary isometric contraction torque assessed in a dynamometer
At baseline and at 5-year intervals for up to 20 years
Free-living glycaemic control
Prazo: At baseline and at 5-year intervals for up to 20 years
Continuous glucose monitoring-derived glycaemic metrics during free-living conditions
At baseline and at 5-year intervals for up to 20 years
Dietary intake
Prazo: 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.
At baseline and at 5-year intervals for up to 20 years
Subcutaneous adipose tissue phenotyping
Prazo: At baseline and at 5-year intervals for up to 20 years
Proteomics derived measures of adipose tissue phenotype
At baseline and at 5-year intervals for up to 20 years
Maximal fat oxidation rate
Prazo: At baseline and at 5-year intervals for up to 20 years
Maximal fat oxidation rate obtained using indirect calorimetry during incremental cycling
At baseline and at 5-year intervals for up to 20 years
Pulsewave velocity
Prazo: At baseline and at 5-years intervals for up to 20 years
Carotid-femoral pulsewave velocity measured using Doppler echocardiography with ECG gating
At baseline and at 5-years intervals for up to 20 years
Resting heart rate
Prazo: At baseline and at 5-year intervals for up to 20 years
Resting heart rate assessed using a chest-worn heart rate monitor
At baseline and at 5-year intervals for up to 20 years
Heart rate variability
Prazo: At baseline and at 5-year intervals for up to 20 years
Heart rate variability assessed using a chest-worn heart rate monitor
At baseline and at 5-year intervals for up to 20 years

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Blood pressure
Prazo: At baseline and at 5-year intervals for up to 20 years
Systolic and diastolic blood pressure obtained using a sphygmomanometer
At baseline and at 5-year intervals for up to 20 years
10 s sprint peak and average power
Prazo: At baseline and at 5-year intervals for up to 20 years
Peak and average power output during a 10 s sprint test
At baseline and at 5-year intervals for up to 20 years
Lactate accumulation
Prazo: At baseline and at 5-year intervals for up to 20 years
Lactate accumulation during a 10 s cycling sprint test
At baseline and at 5-year intervals for up to 20 years
Blood lipid profile
Prazo: 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
At baseline and at 5-year intervals for up to 20 years
Bone measurements
Prazo: At baseline and at 5-year intervals for up to 20 years
Bone density assessed using peripheral quantitative computed tomography (pQCT).
At baseline and at 5-year intervals for up to 20 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University Ghent

Colaboradores

University Hospital, Ghent

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

19 de maio de 2025

Conclusão Primária (Estimado)

31 de dezembro de 2046

Conclusão do estudo (Estimado)

31 de dezembro de 2046

Datas de inscrição no estudo

Enviado pela primeira vez

12 de fevereiro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de junho de 2026

Primeira postagem (Real)

1 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ONZ-2024-0588

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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