Clinical trial NCT03863379: Sarcopenic Obesity in Neurodisabilities
Official title: Sarcopenic Obesity in Neurodisabled People
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenic Obesity
Spinal Cord Injuries
Stroke
Multiple Sclerosis
Traumatic Brain Injury
Keywords: Sarcopenia
sarcopenic obesity
stroke
sci
TBI
MS
Lead sponsor: Dionyssiotis, Yannis, M.D.
Sponsor class: INDIV
Collaborators: name: University of Athens
name: University of Patras
First posted: 2019-03-05
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Fat and lean mass in neurodisabled
timeFrame: an average of 1 year
measure: Frequency of sarcopenic obesity
timeFrame: an average of 1 year
Secondary outcomes:
measure: Body mass index correlation with fat mass and visceral fat
timeFrame: an average of 1 year
Other outcomes:
Locations:
city: Ilion
country: Greece
facility: National Rehabilitation Center EKA
state: Athens
Study officials:
References:
citation: 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.
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.
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.
citation: 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.