Sarcopenic Obesity in Neurodisabilities (SarcObeNDS)

January 25, 2023 updated by: Yannis Dionyssiotis, Dionyssiotis, Yannis, M.D.

Sarcopenic Obesity in Neurodisabled People

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
    • Athens
      • Ilion, Athens, Greece, 13122
        • National Rehabilitation Center EKA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fat and lean mass in neurodisabled
Time Frame: an average of 1 year
an average of 1 year
Frequency of sarcopenic obesity
Time Frame: an average of 1 year
an average of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Body mass index correlation with fat mass and visceral fat
Time Frame: an average of 1 year
an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dionyssiotis, Yannis, M.D.

Collaborators

University of Athens
University of Patras

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2019

Primary Completion (Actual)

June 15, 2021

Study Completion (Actual)

May 15, 2022

Study Registration Dates

First Submitted

February 28, 2019

First Submitted That Met QC Criteria

March 1, 2019

First Posted (Actual)

March 5, 2019

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFIAP2019-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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