Molecular Mechanisms Underpinning Sarcopenic Obesity

Obesity Clinical Trial

Official title:

Molecular Mechanisms Underpinning Sarcopenic Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06120647
• Other study ID #: 2019-04016
• Status: Recruiting
• Start date: January 28, 2020
• Est. completion date: December 30, 2025

Study information

• Verified date: December 2023
• Source: The Swedish School of Sport and Health Sciences
• Contact: William Apró, PhD
• Phone: 08-120 538 67
• Email: william.apro[@]gih.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2025
• Est. primary completion date: December 15, 2025
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Aging
• Obesity
• Sarcopenia
• Sarcopenic Obesity

Intervention

Dietary Supplement:
• Essential amino acids (EAA)
intake of 240 mg EAA per kg lean body mass after a resistance exercise session

Locations

Country	Name	City	State
Sweden	The Swedish School of Sport and Health Sciences	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
The Swedish School of Sport and Health Sciences

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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