Clinical trial NCT02994901: Cause and Importance of the Age-dependent Sarcopenia
Official title: Cause and Importance of the Age-dependent Sarcopenia With a Blood Based Bioenergetics & Cytokine Profiling Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Keywords: Sarcopenia
Geriatrics
Biomarker
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Institute of Human Nutrition
First posted: 2016-12-16
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Group 1: sarcopenic patient Group 2: non-sarcopenic patient Group 3: healthy control

Brief summary: The goal of this cross-sectional study is to evaluate the difference in cytokine profiling approach and mitochondrial function between geriatric sarcopenic patients (group 1) and geriatric non-sarcopenic patients (group 2) and healthy (group 3) geriatric participants.

Detailed description: Study participants (group 1\&2) are assessed during the hospital stay and age-matched controls (group 3) will be recruited through Flyers.

The investigators aim to isolate and cryopreserve peripheral blood mononuclear cells (PBMCs) from whole blood to perform functional assays on mitochondrial respiratory capacity and ROS. Furthermore, the investigators will investigate the association between biomarkers and frailty, quality of life, functional performance, fatigue and risk of depression.

The investigators hypothesize that this profiling approach will allow the evaluation of the progression of age-dependent sarcopenia and uncover novel therapeutic targets.

Eligibility criteria: Inclusion Criteria:

* Age between 60 and 85 years
* Informed written consent
* Normal cognitive status according to Mini-Mental State Examination (MMSE ≥ 24 points)
* Life expectancy of \> 3 months according to treating doctor
* without implanted Defibrillation
* without acute Sepsis
* without neurodegenerative diseases, especially amyotrophic lateral sclerosis (ALS) and Huntington

Exclusion Criteria:

* Age \< 60 years or \> 85 years
* Lack of informed written consent
* Low cognitive status according to Mini-Mental State Examination (MMSE \< 24 points)
* Life expectancy of \< 3 months according to treating doctor
* Implanted Defibrillation
* Acute Sepsis
* neurodegenerative diseases, especially amyotrophic lateral sclerosis (ALS) and Huntington

Primary outcomes:
measure: Differences in mitochondrial respiratory capacity of peripheral blood mononuclear cells (PBMCs) using Oxygraph-2k respirometry
timeFrame: Baseline
Secondary outcomes:
measure: Quality of life (validated questionnaire)
timeFrame: Baseline
measure: Frailty Status according to Fried et.al. criteria
timeFrame: Baseline
measure: Functional limitations (single validated questionnaire)
timeFrame: Baseline
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Medicine, Research Group on Geriatrics
Study officials:
affiliation: Charite Research Group on Geriatrics
name: Kristina Norman, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marzetti E, Calvani R, Cesari M, Buford TW, Lorenzi M, Behnke BJ, Leeuwenburgh C. Mitochondrial dysfunction and sarcopenia of aging: from signaling pathways to clinical trials. Int J Biochem Cell Biol. 2013 Oct;45(10):2288-301. doi: 10.1016/j.biocel.2013.06.024. Epub 2013 Jul 8.
citation: Leger B, Derave W, De Bock K, Hespel P, Russell AP. Human sarcopenia reveals an increase in SOCS-3 and myostatin and a reduced efficiency of Akt phosphorylation. Rejuvenation Res. 2008 Feb;11(1):163-175B. doi: 10.1089/rej.2007.0588.