Correlation of Muscle Ultrasound Measures (2D and 3D) With Biphotonic X-ray Absorptiometry in Oldest Old Patients. (DIASEM)

November 10, 2022 updated by: Nantes University Hospital
The sarcopenia diagnosis is based on the muscle mass and on impaired physical performance. The emerging field of ultrasound assessment of muscle mass in older patients is based on 2d parameters with prediction equations for muscle mass. For the moment, validation of prediction equations in older adults with varying function and health is lacking. The study aims to evaluate correlation of muscle mass between 3D muscle mass measurement and DXA, in order to dispense with the prediction equation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Older patients who agree to participate to the study will undergo 3D ultrasound muscle mass measurement, 2D panoramic mode muscle mass measurement and biphotonic X-ray absorptiometry assessment. Correlation analysis will be done with the different measurement.

Study Type

Observational

Enrollment (Actual)

62

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

  • France
      • Nantes, France
        • CHU de Nantes

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

75 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Older patients who agrees to participate to the study will undergo 3D ultrasound muscle mass measurement, 2D panoramic mode muscle mass measurement and biphotonic X-ray absorptiometry assessment, the same day. Correlation analysis will be done with the different measurement.

Description

Inclusion Criteria:

  • Patients over 75 years old
  • Osteoporosis diagnosis confirmed by Dual-energy X-ray Absorptiometry

Exclusion Criteria:

  • Neurocognitive disorders preventing the expression of informed consent
  • Patients who cannot undergo an examination in a static position
  • Lack of a measurement site (muscle resection or amputation)
  • Any state of dehydration or water inflation
  • Patient with legal protection measure

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
3D Correlation between muscle volume measured by 3D ultrasound and standard method : DXA results
Time Frame: 1 week
Correlation between muscle volume measured by 3D ultrasound and standard method : DXA results
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2D correlation between muscle volume measured by 2D ultrasound and standard method : DXA results
Time Frame: 1 week
Correlation between muscle volume measured by 2D ultrasound and standard method : DXA results
1 week

Collaborators and Investigators

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

Sponsor

Nantes University Hospital

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)

March 9, 2021

Primary Completion (Actual)

October 19, 2022

Study Completion (Actual)

October 19, 2022

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 10, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC20_0534

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

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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