- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04288401
Prevalence of Osteosarcopenic Obesity in Older Adults
May 16, 2020 updated by: Esma Nur KOLBAŞI, Istanbul Medeniyet University
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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
460
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey, 34700
- Goztepe Training and Research Hospital
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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
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
older adults at the age of 65 or over
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Severe cognitive dysfunction
- not being able to walk independently for 4 m
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 hour
|
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
|
5 minutes
|
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
|
2 minutes
|
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.
|
3 minutes
|
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 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comorbidity
Time Frame: 3 minutes
|
Using Charlson Comorbidity Index
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3 minutes
|
History of falls
Time Frame: 1 minutes
|
A patient's self stated history of falls will be considered as having a history of fall or not.
|
1 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
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)
February 25, 2020
Primary Completion (Actual)
March 31, 2020
Study Completion (Actual)
April 1, 2020
Study Registration Dates
First Submitted
February 26, 2020
First Submitted That Met QC Criteria
February 26, 2020
First Posted (Actual)
February 28, 2020
Study Record Updates
Last Update Posted (Actual)
May 19, 2020
Last Update Submitted That Met QC Criteria
May 16, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Musculoskeletal Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Bone Diseases
- Muscular Atrophy
- Atrophy
- Obesity
- Sarcopenia
- Osteoporosis
- Bone Diseases, Metabolic
Other Study ID Numbers
- IstanbulMU3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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