Sarcopenic ObesitySarcObeNDSNCT03863379
Sarcopenic Obesity in Neurodisabilities
An observational study of Sarcopenic Obesity and Spinal Cord Injuries, run by Dionyssiotis, Yannis, M.D. at 1 site in Greece.
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 Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenic Obesity, Spinal Cord Injuries, Stroke
- What is being tested?
- whole body DXA
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- 2 May 2019to 15 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Persons with
- stroke / cerebrovascular disease
- traumatic brain injury
- multiple sclerosis
- spinal cord injuries (including spinal cord lesions i.e. myelopathies etc.)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Sarcopenic Obesity, Spinal Cord Injuries, Stroke, Multiple Sclerosis, Traumatic Brain Injury
- Being tested
- whole body DXA
- Keywords
- Sarcopenia, sarcopenic obesity, stroke, sci, TBI, MS
- Medical subject headings
- Spinal Cord Injuries, Stroke, Multiple Sclerosis, Brain Injuries, Traumatic, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body DXADiagnostic test
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%.
| Study group | Role | What they receive |
|---|---|---|
| Neurodisabled persons | Persons with various neurodisabilities Receives: Diagnostic Test: whole body DXA | |
| Control group | Able bodied persons Receives: Diagnostic Test: whole body DXA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat and lean mass in neurodisabled
Measured: an average of 1 year
Frequency of sarcopenic obesity
Measured: an average of 1 year
Secondary outcomes (1)
Body mass index correlation with fat mass and visceral fat
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start2 May 2019
- Primary completion15 Jun 2021
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sarcopenic ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dionyssiotis, Yannis, M.D.
- Collaborators
- University of Athens, University of Patras
- Responsible party
- Principal investigator, Yannis Dionyssiotis, University General Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863379
- Sponsor's protocol ID
- AFIAP2019-01
- Acronym
- SarcObeNDS
- Status last verified
- Jan 2023
- First submitted
- 28 Feb 2019
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27702700Pelletier 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.
PubMed 27282328Polyzos SA, Margioris AN. Sarcopenic obesity. Hormones (Athens). 2018 Sep;17(3):321-331. doi: 10.1007/s42000-018-0049-x. Epub 2018 Jul 16.
PubMed 30014320Dionyssiotis 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.
PubMed 35928890
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenic Obesity in Neurodisabled People
- ClinicalTrials.gov ID
- NCT03863379
- Acronym / sponsor ID
- SarcObeNDS / AFIAP2019-01
- Conditions
- Sarcopenic Obesity, Spinal Cord Injuries, Stroke, Multiple Sclerosis, Traumatic Brain Injury
- Keywords
- Sarcopenia, sarcopenic obesity, stroke, sci, TBI, MS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Dionyssiotis, Yannis, M.D.
- Collaborators
- University of Athens, University of Patras
- Study start
- 2 May 2019 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To describe the frequency and thresholds for sarcopenic obesity in neurodisabled persons and the fat and lean mass distribution based on various neurodisabilities
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurodisabled persons | – | Diagnostic Test: whole body DXAPersons with various neurodisabilities |
| Control group | – | Diagnostic Test: whole body DXAAble bodied persons |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Persons with
- stroke / cerebrovascular disease
- traumatic brain injury
- multiple sclerosis
- spinal cord injuries (including spinal cord lesions i.e. myelopathies etc.)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole body DXAMeasurements 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%. | Diagnostic test | Control group, Neurodisabled persons |
Primary outcome
Fat and lean mass in neurodisabled
Time frame: an average of 1 year
Frequency of sarcopenic obesity
Time frame: an average of 1 year
1 secondary outcome
Body mass index correlation with fat mass and visceral fat
Time frame: an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Results publication: PubMed 27702700Kalinkovich 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.
- Results publication: PubMed 27282328Pelletier 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.
- Results publication: PubMed 30014320Polyzos SA, Margioris AN. Sarcopenic obesity. Hormones (Athens). 2018 Sep;17(3):321-331. doi: 10.1007/s42000-018-0049-x. Epub 2018 Jul 16.
- Derived from this study: PubMed 35928890Dionyssiotis 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenic Obesity and Spinal Cord Injuries, run by Dionyssiotis, Yannis, M.D. at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat and lean mass in neurodisabled (time frame: an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03863379, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.