NCT04288401

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

1 month

First QC Date

February 26, 2020

Last Update Submit

May 16, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

    1 hour

  • Muscle Strength

    Measured by hand held dynamometer. The cut-off scores for man and woman are 27 kg and 16 kg, respectively

    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

    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.

    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.

    2 minutes

Secondary Outcomes (2)

  • Comorbidity

    3 minutes

  • History of falls

    1 minutes

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

older adults at the age of 65 or over

You may qualify if:

  • 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)

You may not qualify if:

  • Severe cognitive dysfunction
  • not being able to walk independently for 4 m

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goztepe Training and Research Hospital

Istanbul, 34700, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

ObesitySarcopeniaBone Diseases, MetabolicOsteoporosis

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalBone DiseasesMusculoskeletal DiseasesMetabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 26, 2020

First Posted

February 28, 2020

Study Start

February 25, 2020

Primary Completion

March 31, 2020

Study Completion

April 1, 2020

Last Updated

May 19, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations