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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03863379
Other study ID # AFIAP2019-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2, 2019
Est. completion date May 15, 2022

Study information

Verified date January 2023
Source Dionyssiotis, Yannis, M.D.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date May 15, 2022
Est. primary completion date June 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria: Persons with - stroke / cerebrovascular disease - traumatic brain injury - multiple sclerosis - spinal cord injuries (including spinal cord lesions i.e. myelopathies etc.) Exclusion Criteria: 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.

Study Design


Intervention

Diagnostic Test:
whole body DXA
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%.

Locations

Country Name City State
Greece National Rehabilitation Center EKA Ilion Athens

Sponsors (3)

Lead Sponsor Collaborator
Dionyssiotis, Yannis, M.D. University of Athens, University of Patras

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Fat and lean mass in neurodisabled an average of 1 year
Primary Frequency of sarcopenic obesity an average of 1 year
Secondary Body mass index correlation with fat mass and visceral fat an average of 1 year
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