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

2026年6月24日 更新者：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.

調査の概要

状態

募集

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

250

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

なし

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Whole-body insulin sensitivity
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Skeletal muscle fiber type
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Blood pressure
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University Ghent

協力者

University Hospital, Ghent

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年5月19日

一次修了 (推定)

2046年12月31日

研究の完了 (推定)

2046年12月31日

試験登録日

最初に提出

2026年2月12日

QC基準を満たした最初の提出物

2026年6月24日

最初の投稿 (実際)

2026年7月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月1日

QC基準を満たした最後の更新が送信されました

2026年6月24日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • ONZ-2024-0588

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