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L'essai clinique NCT06120647 pour Obésité sarcopénique, Obésité, Sarcopénie, Vieillissement est 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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Molecular Mechanisms Underpinning Sarcopenic Obesity
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L'étude clinique NCT06120647 est un essai observationnel pour Obésité sarcopénique, Obésité, Sarcopénie, Vieillissement. Son statut actuel est : en recrutement. L'étude a débuté le 28 janvier 2020 et vise à recruter 60 participants. Dirigé par The Swedish School of Sport and Health Sciences, l'essai devrait être terminé d'ici le 30 décembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 11 décembre 2023.
Résumé succinct
The coexistence of obesity and sarcopenia results in sarcopenic obesity, a high-risk geriatric condition associated with metabolic perturbations and several co-morbidities. Despite the rising numbers of older adults diagnosed with sarcopenic obesity, few studies have characterized this condition on the muscle cell and systemic level. This study sought to comprehensively assess the influence of sarcopenic obesity on muscle and blood-related parameters and compare it to non-sarocopenic obese and non-sarcopenic lean older adults.
Titre officiel
Molecular Mechanisms Underpinning Sarcopenic Obesity
Conditions
Obésité sarcopéniqueObésitéSarcopénieVieillissementAutres identifiants de l'essai
- 2019-04016
Numéro NCT
Date de début (réel)
2020-01-28
Dernière mise à jour publiée
2023-12-11
Date de fin (estimée)
2025-12-30
Inscription (estimée)
60
Type d'essai
Observationnel
Statut
En recrutement
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Sarcopenic obesity Age: 70-80 years Men, ALM/W \< 25.7 %, body fat % \> 35 Women, ALM/W \< 19.7 %, body fat % \> 40 | Essential Amino Acids (EAA) intake of 240 mg EAA per kg lean body mass after a resistance exercise session |
Non-sarcopenic obese Age: 70-80 years Men, ALM/W \> 25.7 %, body fat % \> 35 Women, ALM/W \> 19.7 %, body fat % \> 40 | Essential Amino Acids (EAA) intake of 240 mg EAA per kg lean body mass after a resistance exercise session |
Non-sarcopenic lean Age: 70-80 years Men, ALM \> 7.0 kg/m2, body fat % \< 25 Women, ALM \> 5.5 kg/m2, body fat % \< 32 | Essential Amino Acids (EAA) intake of 240 mg EAA per kg lean body mass after a resistance exercise session |
Young lean Age: 18-40 years Men, ALM \> 7.0 kg/m2, body fat % \< 25 Women, ALM \> 5.5 kg/m2, body fat % \< 32 | Essential Amino Acids (EAA) intake of 240 mg EAA per kg lean body mass after a resistance exercise session |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Fiber type-specific cell signalling | This measure will be investigated during an experimental trial in which the participants are subjected to an acute bout of resistance exercise followed by the ingestion of essential amino acids (240 mg/kg lean mass). During this 3 hour time period, the participants will donate two muscle biopsies, one before exercise and the second one 1 hour after exercise. Cell signalling networks related to muscle mass regulation will be examined in these biopsy samples. The signal will be measured using Western blotting and the signal obtained is expressed in relation to baseline (adjusted volume intensity). | 1 hour after ingestion of essential amino acids and resistance exercise |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Skeletal muscle fiber characteristics | Fiber type-specific area measured using immunofluorescence microscope in muscle biopsies collected at baseline (prior to ingestion of essential amino acids and resistance exercise). Unit of measurement is square micrometers (µm\^2). | 1 hour prior to ingestion of essential amino acids and resistance exercise |
Whole body muscle volume | Indices of muscle volume and fat infiltration obtained with magnetic resonance imaging (MRI). Unit of measurement is cubic centrimeters (cm\^3). | 1 hour |
Whole body glucose tolerance | Oral glucose tolerance test in which the participants will ingest a standardized glucose drink and blood glucose levels will be monitored throughout a period of 2 hours. Unit of measurement is mmol/L glucose. | 2 hours |
Accelerometer-assessed physical activity levels | Hip-worn accelerometer data (Actigraph GT3X) collected over 7 consecutive days. Unit of measurement is steps per day. | 1 week |
Isometric and isokinetic leg muscle strength | Muscle performance will be evaluated at a single timepoint during the study using IsoMed2000 dynamometer. Participants will perform a maximal isometric contraction at 60 degrees of knee flexion. Unit of measurement is Newton meter (N-m). | 1 hour |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- Body fat % in accordance with previously defined criteria
- Free of smoking (since 10 years)
- Able to walk without assistance
- Able to perform bilateral leg extension exercise
- History of or present disease of myocardial, vascular, endocrine, hepatic, renal, pulmonary or neuromuscular origin
- Uncontrolled hypo/hypertension
- Use of anticoagulants (Warfarin, Trombyl)
- Use of metformin or other anti-diabetic medications
- Poor appetite and unexplained weight loss (4,5 kg) over the past 6 months
- Active malignancy
- Present infection
- Dementia or delirium
- Other conditions that may interfere with the study protocol in the opinion of the PI
Partie responsable de l'essai
William Apro, Investigateur principal, Associate Professor, The Swedish School of Sport and Health Sciences
Contact central de l'essai
Contact: William Apró, PhD, 08-120 538 67, [email protected]
1 Centres de l'essai dans 1 pays
The Swedish School of Sport and Health Sciences, Stockholm, 11433, Sweden
Oscar Horwath, MSc, Contact, [email protected]
En recrutement