NCT03863379

Brief Summary

To describe the frequency and thresholds for sarcopenic obesity in neurodisabled persons and the fat and lean mass distribution based on various neurodisabilities

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 May 2019

Typical duration 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

First Submitted

Initial submission to the registry

February 28, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 2, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

2.1 years

First QC Date

February 28, 2019

Last Update Submit

January 25, 2023

Conditions

Sarcopenic ObesitySpinal Cord InjuriesStrokeMultiple SclerosisTraumatic Brain Injury

Keywords

Sarcopeniasarcopenic obesitystrokesciTBIMS

Outcome Measures

Primary Outcomes (2)

  • Fat and lean mass in neurodisabled

    an average of 1 year

  • Frequency of sarcopenic obesity

    an average of 1 year

Secondary Outcomes (1)

  • Body mass index correlation with fat mass and visceral fat

    an average of 1 year

Study Arms (2)

Neurodisabled persons

Persons with various neurodisabilities

Diagnostic Test: whole body DXA

Control group

Able bodied persons

Diagnostic Test: whole body DXA

Interventions

whole body DXADIAGNOSTIC_TEST

Measurements of body composition may be used to study how lean body mass and body fat change during health and disease and have provided a research tool to study the metabolic effects of obesity and various wasting conditions. DXA measurements are based in part on the assumption that the hydration of fat-free mass remains constant at 73%.

Control groupNeurodisabled persons

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Persons with neurodisability, men and women in comparison with able-bodied controls. Controls considered healthy after physical examination and comprehensive medical history review, which was free of any previous fracture ,endocrine or metabolic bone disease, malignancy, drug abuse, alcoholism and hepatic or renal disorders.

You may qualify if:

  • Persons with
  • stroke / cerebrovascular disease
  • traumatic brain injury
  • multiple sclerosis
  • spinal cord injuries (including spinal cord lesions i.e. myelopathies etc.)

You may not qualify if:

  • Persons with
  • heterotopic ossifications,
  • chronic administration of drugs, which promote fat increase
  • chronic administration of drugs, which promote bone or muscle loss
  • co-existing other diseases such as: endocrinopathies, muscular dystrophies, non-alcoholic fatty liver disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Rehabilitation Center EKA

Nea Liosia, Athens, 13122, Greece

Location

Related Publications (4)

  • Kalinkovich A, Livshits G. Sarcopenic obesity or obese sarcopenia: A cross talk between age-associated adipose tissue and skeletal muscle inflammation as a main mechanism of the pathogenesis. Ageing Res Rev. 2017 May;35:200-221. doi: 10.1016/j.arr.2016.09.008. Epub 2016 Oct 1.

    PMID: 27702700RESULT

  • Pelletier CA, Miyatani M, Giangregorio L, Craven BC. Sarcopenic Obesity in Adults With Spinal Cord Injury: A Cross-Sectional Study. Arch Phys Med Rehabil. 2016 Nov;97(11):1931-1937. doi: 10.1016/j.apmr.2016.04.026. Epub 2016 Jun 7.

    PMID: 27282328RESULT

  • Polyzos SA, Margioris AN. Sarcopenic obesity. Hormones (Athens). 2018 Sep;17(3):321-331. doi: 10.1007/s42000-018-0049-x. Epub 2018 Jul 16.

    PMID: 30014320RESULT

  • Dionyssiotis Y, Prokopidis K, Trovas G, Papadatou MC, Ananidis N, Tragoulias V, Lazarou E, Christaki E, Domazou M, Galanos A, Tyllianakis M. Sarcopenic Obesity in Individuals With Neurodisabilities: The SarcObeNDS Study. Front Endocrinol (Lausanne). 2022 Jul 19;13:868298. doi: 10.3389/fendo.2022.868298. eCollection 2022.

    PMID: 35928890DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesStrokeMultiple SclerosisBrain Injuries, TraumaticSarcopenia

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersBrain DiseasesVascular DiseasesCardiovascular DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBrain InjuriesCraniocerebral TraumaMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant of 1st PRM Department National Rehabilitation Center EKA, Athens, Greece

Study Record Dates

First Submitted

February 28, 2019

First Posted

March 5, 2019

Study Start

May 2, 2019

Primary Completion

June 15, 2021

Study Completion

May 15, 2022

Last Updated

January 27, 2023

Record last verified: 2023-01

Locations

GR(1)