- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06120647
Molecular Mechanisms Underpinning Sarcopenic Obesity
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: William Apró, PhD
- Phone Number: +46 08-120 538 67
- Email: william.apro@gih.se
Study Locations
-
-
-
Stockholm, Sweden, 11433
- Recruiting
- The Swedish School of Sport and Health Sciences
-
Contact:
- Oscar Horwath, MSc
- Email: oscar.horwath@gih.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The elderly participants will be community-dwelling living in the greater Stockholm metropolitan area. Participants will be recruited through local senior clubs, online communities, advertisement and word of mouth.
The young participants will be living in the greater Stockholm metropolitan area. Participants will be recruited through university forums, online communities, advertisement and word of mouth.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Sarcopenic obesity
Age: 70-80 years Men, ALM/W < 25.7 %, body fat % > 35 Women, ALM/W < 19.7 %, body fat % > 40
|
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
|
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
|
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
|
intake of 240 mg EAA per kg lean body mass after a resistance exercise session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fiber type-specific cell signalling
Time Frame: 1 hour after ingestion of essential amino acids and resistance exercise
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whole body glucose tolerance
Time Frame: 2 hours
|
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
Time Frame: 1 week
|
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
Time Frame: 1 hour
|
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
|
Skeletal muscle fiber characteristics
Time Frame: 1 hour prior to ingestion of essential amino acids and resistance exercise
|
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
Time Frame: 1 hour
|
Indices of muscle volume and fat infiltration obtained with magnetic resonance imaging (MRI).
Unit of measurement is cubic centrimeters (cm^3).
|
1 hour
|
Collaborators and Investigators
Investigators
- Principal Investigator: William Apró, PhD, The Swedish School of Sport and Health Sciences and Karolinska Institute, Stockholm Sweden
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-04016
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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