SarcopeniaSARCOPENIANCT02994901
Cause and Importance of the Age-dependent Sarcopenia
An observational study of Sarcopenia, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2016to 30 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1: sarcopenic patient Group 2: non-sarcopenic patient Group 3: healthy control
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charite University Medicine, Research Group on Geriatrics
Berlin, 13347
About this study
Official title: 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.
Read the 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.
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Geriatrics, Biomarker
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Geriatric patient with Sarcopenia | |
| Group 2 | Geriatric Patient without Sarcopenia | |
| Group 3 | healthy control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in mitochondrial respiratory capacity of peripheral blood mononuclear cells (PBMCs) using Oxygraph-2k respirometry
Measured: Baseline
Secondary outcomes (3)
Quality of life (validated questionnaire)
Measured: Baseline
Frailty Status according to Fried et.al. criteria
Measured: Baseline
Functional limitations (single validated questionnaire)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study start1 Nov 2016
- Primary completion1 Jun 2017
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Institute of Human Nutrition
- Responsible party
- Principal investigator, Kristina Norman, Charite University, Berlin, Germany
- Investigators
- Kristina Norman, PD Dr., Principal investigator, Charite Research Group on Geriatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994901
- Sponsor's protocol ID
- EA1/260/16
- Acronym
- SARCOPENIA
- Status last verified
- Jan 2020
- First submitted
- 7 Dec 2016
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23845738Leger 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.
PubMed 18240972
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cause and Importance of the Age-dependent Sarcopenia With a Blood Based Bioenergetics & Cytokine Profiling Approach
- ClinicalTrials.gov ID
- NCT02994901
- Acronym / sponsor ID
- SARCOPENIA / EA1/260/16
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Geriatrics, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Institute of Human Nutrition
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Geriatric patient with Sarcopenia |
| Group 2 | – | –Geriatric Patient without Sarcopenia |
| Group 3 | – | –healthy control group |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: sarcopenic patient Group 2: non-sarcopenic patient Group 3: healthy control
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in mitochondrial respiratory capacity of peripheral blood mononuclear cells (PBMCs) using Oxygraph-2k respirometry
Time frame: Baseline
3 secondary outcomes
Quality of life (validated questionnaire)
Time frame: Baseline
Frailty Status according to Fried et.al. criteria
Time frame: Baseline
Functional limitations (single validated questionnaire)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Background: PubMed 23845738Marzetti 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.
- Background: PubMed 18240972Leger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Norman, PD Dr. principal investigator
Charite Research Group on Geriatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in mitochondrial respiratory capacity of peripheral blood mononuclear cells (PBMCs) using Oxygraph-2k respirometry (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02994901, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.