ObesityNCT04288401
Prevalence of Osteosarcopenic Obesity in Older Adults
An observational study of Obesity and Sarcopenia, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
Osteosarcopenic Obesity (OSO) is a syndrome characterized by the loss of bone and muscle in addition to increase in the fat tissue as a result of aging process. It is the latest point of impairment in the bone,muscle and adipose tissue in older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Sarcopenia, Osteopenia
- How many people
- 460 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2020to 1 Apr 2020
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: older adults at the age of 65 or over
Who may be able to join
- Age of 65 or over
- Being had been examined for all the primary outcome measures (i.e. the results of primary outcomes must be in the patient's file)
Who cannot join
- Severe cognitive dysfunction
- not being able to walk independently for 4 m
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Goztepe Training and Research Hospital
Istanbul, 34700
About this study
Official title: Prevalence of Osteosarcopenic Obesity in Older Community-dwelling Adults in Turkey
Osteosarcopenic Obesity (OSO) is a syndrome characterized by the loss of bone and muscle in addition to increase in the fat tissue as a result of aging process. It is the latest point of impairment in the bone,muscle and adipose tissue in older adults. OSO, as the name suggests, is the combination of three syndrome frequently encountered in the elderly: osteopenia/osteoporosis, sarcopenia and obesity. The aims of study are to determine the prevalence of OSO syndrome in community-dwelling adults of Turkey and determine the possible factors regarding risk of falling in this population
- Conditions
- Obesity, Sarcopenia, Osteopenia, Osteoporosis
- Medical subject headings
- Obesity, Sarcopenia, Bone Diseases, Metabolic, Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
T score
T scores of spine and femur neck examined with Dual X-Ray Absorptiometry. A T score<-2,5 will be classified as osteoporosis while a T score between -1 and -2,5 will be counted as osteopenia
Measured: 1 hour
Muscle Strength
Measured by hand held dynamometer. The cut-off scores for man and woman are 27 kg and 16 kg, respectively
Measured: 5 minutes
Muscle Mass
Measured by bioimpedance analysis using Tanita TBF300. The cut-off scores for man and woman are 9,2 kg/m2 and 7,4 kg/m2, respectively
Measured: 2 minutes
Muscle Performance
Tested by 4 meter walk test. If the gait speed is lower than 0,8 m/s, the test is positive.
Measured: 3 minutes
Obesity
The fat percentage and the Body Mass Index measured by bioimpedance analysis using Tanita TBF300 is recorded. For BMI, 30 kg/m2 and over is classified as obesity whereas fat percentage of %35 and %28 (woman and man, respectively) and over was classified as obese.
Measured: 2 minutes
Secondary outcomes (2)
Comorbidity
Using Charlson Comorbidity Index
Measured: 3 minutes
History of falls
A patient's self stated history of falls will be considered as having a history of fall or not.
Measured: 1 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start25 Feb 2020
- Primary completion31 Mar 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Collaborators
- Goztepe Training and Research Hospital
- Responsible party
- Principal investigator, Esma Nur KOLBAŞI, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288401
- Sponsor's protocol ID
- IstanbulMU3
- Status last verified
- May 2020
- First submitted
- 26 Feb 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kolbasi EN, Demirdag F. Prevalence of osteosarcopenic obesity in community-dwelling older adults: a cross-sectional retrospective study. Arch Osteoporos. 2020 Oct 20;15(1):166. doi: 10.1007/s11657-020-00829-x.
PubMed 33079259
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Osteosarcopenic Obesity in Older Community-dwelling Adults in Turkey
- ClinicalTrials.gov ID
- NCT04288401
- Acronym / sponsor ID
- IstanbulMU3
- Conditions
- Obesity, Sarcopenia, Osteopenia, Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Collaborators
- Goztepe Training and Research Hospital
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 28 Feb 2020 (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.
Osteosarcopenic Obesity (OSO) is a syndrome characterized by the loss of bone and muscle in addition to increase in the fat tissue as a result of aging process. It is the latest point of impairment in the bone,muscle and adipose tissue in older adults. OSO, as the name suggests, is the combination of three syndrome frequently encountered in the elderly: osteopenia/osteoporosis, sarcopenia and obesity. The aims of study are to determine the prevalence of OSO syndrome in community-dwelling adults of Turkey and determine the possible factors regarding risk of falling in this population
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- older adults at the age of 65 or over
Key inclusion criteria (2 listed)
- Age of 65 or over
- Being had been examined for all the primary outcome measures (i.e. the results of primary outcomes must be in the patient's file)
Key exclusion criteria (2 listed)
- Severe cognitive dysfunction
- not being able to walk independently for 4 m
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
T score
Time frame: 1 hour
T scores of spine and femur neck examined with Dual X-Ray Absorptiometry. A T score<-2,5 will be classified as osteoporosis while a T score between -1 and -2,5 will be counted as osteopenia
Muscle Strength
Time frame: 5 minutes
Measured by hand held dynamometer. The cut-off scores for man and woman are 27 kg and 16 kg, respectively
Muscle Mass
Time frame: 2 minutes
Measured by bioimpedance analysis using Tanita TBF300. The cut-off scores for man and woman are 9,2 kg/m2 and 7,4 kg/m2, respectively
Muscle Performance
Time frame: 3 minutes
Tested by 4 meter walk test. If the gait speed is lower than 0,8 m/s, the test is positive.
Obesity
Time frame: 2 minutes
The fat percentage and the Body Mass Index measured by bioimpedance analysis using Tanita TBF300 is recorded. For BMI, 30 kg/m2 and over is classified as obesity whereas fat percentage of %35 and %28 (woman and man, respectively) and over was classified as obese.
2 secondary outcomes
Comorbidity
Time frame: 3 minutes
History of falls
Time frame: 1 minutes
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 19 May 2020.
- Derived from this study: PubMed 33079259Kolbasi EN, Demirdag F. Prevalence of osteosarcopenic obesity in community-dwelling older adults: a cross-sectional retrospective study. Arch Osteoporos. 2020 Oct 20;15(1):166. doi: 10.1007/s11657-020-00829-x.
- Individual participant dataSharing planned: No
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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 Obesity and Sarcopenia, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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 19 May 2020. 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 Turkey (Türkiye). 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?
T score (time frame: 1 hour). The study lists 5 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 NCT04288401, which also lists 1 linked publication.
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 19 May 2020.