Cause and Importance of the Age-dependent Sarcopenia

Sarcopenia Clinical Trial

— SARCOPENIA  

Official title:

Cause and Importance of the Age-dependent Sarcopenia With a Blood Based Bioenergetics & Cytokine Profiling Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994901
• Other study ID #: EA1/260/16
• Status: Completed
• Start date: November 1, 2016
• Est. completion date: July 30, 2017

Study information

• Verified date: January 2020
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 30, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Locations

Country	Name	City	State
Germany	Charite University Medicine, Research Group on Geriatrics	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Institute of Human Nutrition

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Léger 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in mitochondrial respiratory capacity of peripheral blood mononuclear cells (PBMCs) using Oxygraph-2k respirometry		Baseline
Secondary	Quality of life (validated questionnaire)		Baseline
Secondary	Frailty Status according to Fried et.al. criteria		Baseline
Secondary	Functional limitations (single validated questionnaire)		Baseline