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L'essai clinique NCT05135234 pour Mode de Vie Sédentaire, Hyperinsulinémie, Tolérance au glucose altérée, Low-density-lipoprotein-type, Problèmes liés au vieillissement, Troubles du métabolisme des lipides, Inactivité physique, Metabolic Disorder, Glucose est actif, pas en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Developing a Physiological Understanding of High Duration Activity

Actif, pas en recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT05135234 est un essai interventionnel pour Mode de Vie Sédentaire, Hyperinsulinémie, Tolérance au glucose altérée, Low-density-lipoprotein-type, Problèmes liés au vieillissement, Troubles du métabolisme des lipides, Inactivité physique, Metabolic Disorder, Glucose. Son statut actuel est : actif, pas en recrutement. L'étude a débuté le 1 août 2016 et vise à recruter 60 participants. Dirigé par l'Université de Houston, l'essai devrait être terminé d'ici le 1 décembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 19 mai 2023.
Résumé succinct
When muscles are not contracting, the local energy demand by muscle and use of specific fuels used to produce energy by oxidative metabolism are minimal. The time people spend sitting inactive (sedentary time) typically comprises more than half of the day. This sedentary behavior is associated with elevated risk of diabetes, cardiovascular diseases, some cancers, and multiple conditions leading to poor aging.

From a progressive series of experiments, the driving goal is to develop a physiological method for sustaining contractile activity via oxidative metabolism over more time than is possible by traditional exercise (hours, not minutes per day).

Developing a physiological method suitable of prolonged muscular activity for ordinary people (who are often unfit) requires gaining fundamental insights about muscle biology and biomechanics. This also entails a careful appreciation of the ability to isolate specific muscles in the leg during controlled movements, such as the soleus muscle during isolated plantarflexion. This includes quantifying specific biological processes that are directly responsive to elevated skeletal muscle recruitment. The investigators will focus on movement that is safe and practical for ordinary people to do given their high amount of daily sitting time.

This includes developing methods to optimally raise muscle contractile activity, in a way that is not limited by fatigue, and is feasible throughout as many minutes of the day as possible safely. This also requires development of methodologies to quantify specific muscular activity, rather than generalized body movement.

There is a need to learn how much people can increase muscle metabolism by physical activity that is perceived to them as being light effort. It is important to learn if this impacts systemic metabolic processes under experimental conditions over a short term time span in order to avoid confounding influences of changes in body weight or other factors.

Description détaillée
Physical activity/inactivity will be carefully measured with objective devices. Wearable devices most commonly include accelerometers capable of capturing various types of movement and body posture. The intensity of muscle activation (the soleus and other leg muscles) will be measured in some participants in the developmental studies with EMG, with the limb motion quantified with goniometry. Skeletal muscle and whole body metabolism will be evaluated, especially after isolated local contractile activity focusing on the slow oxidative soleus muscle. Blood chemistry will also be investigated in this comprehensive series of studies to understand how replacing sedentary time with low effort muscular activity can be enhanced. Glycemia will be evaluated in the postprandial period in the morning after an overnight fast when there can be standardized control of carbohydrate ingestion. This includes a standardized oral glucose tolerance test with careful experimental assessment of posture and muscular recruitment during the testing periods. One phase of this study is particularly interested in assessing the acute responses that occur immediately as a result of contractile activity, while also evaluating in another phase how this may be impacted by a change in the sedentary lifestyle. This includes assessing new approaches for improving metabolism throughout the day by reducing the amount of time sitting inactive (i.e. sedentary time). Importantly, because the potential immediate benefits of muscle contractile activity are directly dependent on the duration of activity, the investigators aim to develop in a series of experiments how much muscular activity time can be performed comfortably and safely by anybody instead of sitting inactive with low muscle metabolism regardless of age, fitness, body type, and other conditions commonly limiting effectiveness of traditional exercise prescriptions.
Titre officiel

Adaptive Effects of Very Light Physical Activity on Metabolism

Conditions
Mode de Vie SédentaireHyperinsulinémieTolérance au glucose altéréeLow-density-lipoprotein-typeProblèmes liés au vieillissementTroubles du métabolisme des lipidesInactivité physiqueMetabolic Disorder, Glucose
Autres identifiants de l'essai
  • 15463-01
  • University of Houston (Autre financement) (University of Houston)
Numéro NCT
Date de début (réel)
2016-08
Dernière mise à jour publiée
2023-05-19
Date de fin (estimée)
2025-12
Inscription (estimée)
60
Type d'essai
Interventionnel
PHASE
N/A
Statut
Actif, pas en recrutement
Mots clés
sedentary
physical activity
muscle contractile activity
Objectif principal
Recherche fondamentale
Plan d'attribution
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalMuscular Exercise
Increased level of low effort muscular activity
Muscular Exercise
Sedentary time (muscular inactivity when sitting) will be replaced with low effort muscular activity
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Oxygen cost of isolated muscle contractions
The energetics of isolated muscle contractions will be described relative to the distinct biomechanics of different types of muscular movement
Acute contractile activity (at least 3 minutes)
Fatigue time during muscle group specific contractile activity
Determinants of muscular endurance as a function of recruitment intensity
Acute measurements less than 1 day. The exact duration is an individual response that is an outcome of unknown minutes consistent with the fatiguability of different movements.
Change in postprandial glucose regulation
Glucose concentration response during the postprandial period after an oral glucose tolerance test
The change through the completion of the postprandial period, an average of 180 minutes
Change in very low density lipoprotein (VLDL) - Triglyceride
The concentration of triglyceride in the plasma VLDL lipoprotein
The change through the completion of an acute fasting period, approximately 8-12 hours
The change in muscular inactivity time as a result of isolated contractile activity of the soleus
Development of an objective method(s) to quantify sedentary vs. non sedentary time.
Throughout the waking day (~16 hours).
Angiopoietin-like protein 4
One of the molecular determinants of lipoprotein lipase regulation
The acute time course during the onset of muscular inactivity and contractile activity within 30 minutes to 8 hours
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Recruited mass of the soleus and other muscles in the triceps surae during isolated plantarflexion
grams of the soleus, lateral gastrocnemius and medial gastrocnemius
During acute contractile activity of at least 3 minutes
Electrical activity of muscle, Electromyography (EMG)
The activation of the triceps surae muscle group
At least 3 minute recording periods
Local rate of oxygen consumption of working muscle
oxygen cost per kg muscle during isolated contractile activity and treadmill exercise
Steady-state measurements taken for ~6 continuous minutes of contractile activity
The ratio of carbohydrate vs. fat oxidation
The change in the ratio of the fat vs. carbohydrate utilization during acute contractile activity
Acute responses within less than 24 hours.
Plasma insulin change
Plasma insulin concentration
The change through the completion of the postprandial period, an average of 180 minutes
Sedentary/muscular inactivity time vs. intermittent non-seated standing behaviors
Sedentary time is defined as sitting with a low rate of muscle metabolism due to inactivity
Throughout the waking day (~16 hours).
apolipoprotein B100 concentration change
Biochemical measurement in units of mg per dL
After at least 4 weeks of increased contractile activity
Change in the concentration of GlycA (this is not an acronym; it is a biomarker of inflammation)
Nuclear magnetic resonance in units of umol per L
After at least 4 weeks of increased contractile activity
Small dense LDL concentration change
This is an atherogenic lipoprotein particle
After at least 4 weeks of increased contractile activity
Complement component 3 (C3) concentration change
This is an acute phase protein, a marker of inflammation
After at least 4 weeks of increased contractile activity
Ferritin concentration change
This is a biomarker related to inflammation and diabetes
After at least 4 weeks of increased contractile activity
Plasma triglyceride concentration change
Triglyceride concentration in VLDL and non-VLDL particles
After at least 4 weeks of increased contractile activity
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
  • Age must be 18 years or older
  • Able to fast overnight
  • Can maintain diet, medications, and sleep habits between each of the testing visits.
  • Lifestyle is consistent with participation in a study evaluating reductions of inactivity (defined by sitting at a low metabolic rate because of minimal muscular activity)
  • Willing and able to wear small wearable activity monitors under their clothes as instructed.
  • No plans to start a new diet or exercise program if enrolled in the present study.

  • Practical barriers to completing the study, such as plans to move, or work, or family commitments.
  • Plans to change lifestyle during the present study.
  • Have physical, vocational, or reasons that prohibit ordinary sitting behaviors present in the modern world.
  • Currently dieting to change body weight, or have eating disorder.
  • Are pregnant or plan to become pregnant.
  • Taking medications that affect bleeding (ie anticoagulants).
  • Allergy to lidocaine excludes biopsy component of study.
American Diabetes Association logoAmerican Diabetes Association
Partie responsable de l'essai
Marc Hamilton, Investigateur principal, Professor, University of Houston
Aucune donnée de contact disponible
1 Centres de l'essai dans 1 pays

Texas

University of Houston, Houston, Texas, 77204, United States