Cause and Importance of the Age-dependent Sarcopenia (SARCOPENIA)

January 27, 2020 updated by: Kristina Norman, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13347
        • Charite University Medicine, Research Group on Geriatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Group 1: sarcopenic patient Group 2: non-sarcopenic patient Group 3: healthy control

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1
Geriatric patient with Sarcopenia
Group 2
Geriatric Patient without Sarcopenia
Group 3
healthy control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in mitochondrial respiratory capacity of peripheral blood mononuclear cells (PBMCs) using Oxygraph-2k respirometry
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life (validated questionnaire)
Time Frame: Baseline
Baseline
Frailty Status according to Fried et.al. criteria
Time Frame: Baseline
Baseline
Functional limitations (single validated questionnaire)
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

German Institute of Human Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

July 30, 2017

Study Registration Dates

First Submitted

December 7, 2016

First Submitted That Met QC Criteria

December 13, 2016

First Posted (Estimate)

December 16, 2016

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA1/260/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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