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OpenTrials
Completed

NCT Number: NCT02994901

Cause and Importance of the Age-dependent Sarcopenia

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Charite University Medicine, Research Group on Geriatrics

Berlin, 13347, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Differences in mitochondrial respiratory capacity of peripheral blood mononuclear cells (PBMCs) using Oxygraph-2k respirometry

    Time frame: Baseline

Secondary outcomes

  1. Quality of life (validated questionnaire)

    Time frame: Baseline

  2. Frailty Status according to Fried et.al. criteria

    Time frame: Baseline

  3. Functional limitations (single validated questionnaire)

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • German Institute of Human Nutrition

Registry information

Official study title

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

Acronym: SARCOPENIA

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 16, 2016
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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