NCT02994901

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2017

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

December 7, 2016

Last Update Submit

January 27, 2020

Conditions

Keywords

SarcopeniaGeriatricsBiomarker

Outcome Measures

Primary Outcomes (1)

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

    Baseline

Secondary Outcomes (3)

  • Quality of life (validated questionnaire)

    Baseline

  • Frailty Status according to Fried et.al. criteria

    Baseline

  • Functional limitations (single validated questionnaire)

    Baseline

Study Arms (3)

Group 1

Geriatric patient with Sarcopenia

Group 2

Geriatric Patient without Sarcopenia

Group 3

healthy control group

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University Medicine, Research Group on Geriatrics

Berlin, 13347, Germany

Location

Related Publications (2)

  • 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.

    PMID: 23845738BACKGROUND
  • 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.

    PMID: 18240972BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Kristina Norman, PD Dr.

    Charite Research Group on Geriatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr.

Study Record Dates

First Submitted

December 7, 2016

First Posted

December 16, 2016

Study Start

November 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 30, 2017

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations