Sarcopenic Obesity in Neurodisabilities

Stroke Clinical Trial

— SarcObeNDS  

Official title:

Sarcopenic Obesity in Neurodisabled People

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03863379
• Other study ID #: AFIAP2019-01
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Multiple Sclerosis
• Obesity
• Sarcopenic Obesity
• Spinal Cord Injuries
• Stroke
• Traumatic Brain Injury
• Wounds and Injuries

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