Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sarcopenic Obesity in Neurodisabilities (SarcObeNDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03863379
Recruitment Status : Not yet recruiting
First Posted : March 5, 2019
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
University of Athens
Information provided by (Responsible Party):
Yannis Dionyssiotis, Dionyssiotis, Yannis, M.D.

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

Condition or disease Intervention/treatment
Sarcopenic Obesity Spinal Cord Injuries Stroke Multiple Sclerosis Traumatic Brain Injury Diagnostic Test: whole body DXA

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Sarcopenic Obesity in Neurodisabled People
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Neurodisabled persons
Persons with various neurodisabilities
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%.

Control group
Able bodied persons
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%.




Primary Outcome Measures :
  1. Fat and lean mass in neurodisabled [ Time Frame: an average of 1 year ]
  2. Frequency of sarcopenic obesity [ Time Frame: an average of 1 year ]

Secondary Outcome Measures :
  1. Body mass index correlation with fat mass and visceral fat [ Time Frame: an average of 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Publications of Results:
Layout table for additonal information
Responsible Party: Yannis Dionyssiotis, Consultant of 1st PRM Department National Rehabilitation Center EKA, Athens, Greece, Dionyssiotis, Yannis, M.D.
ClinicalTrials.gov Identifier: NCT03863379     History of Changes
Other Study ID Numbers: AFIAP2019-01
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yannis Dionyssiotis, Dionyssiotis, Yannis, M.D.:
Sarcopenia
sarcopenic obesity
stroke
sci
TBI
MS

Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries
Brain Injuries
Spinal Cord Injuries
Brain Injuries, Traumatic
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Obesity
Multiple Sclerosis
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Central Nervous System Diseases
Spinal Cord Diseases