RECRUITING

Predicting Appendicular Lean and Fat Mass With Bioelectrical Impedance Analysis Among Adult Patients With Obesity.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study aims to develop and cross-validate novel bioelectrical impedance analysis (BIA) equations for predicting appendicular soft tissue masses, specifically fat mass (FM) and appendicular lean mass (ALM), in a sample of Caucasian adult subjects affected by obesity. The research will compare these new BIA equations with three established BIA-derived prediction models and validate them using dual-energy X-ray absorptiometry (DXA) and magnetic resonance imaging (MRI) data. This study utilizes existing datasets to enhance the accuracy and applicability of BIA in assessing body composition and supports the development of standardized algorithms for converting raw BIA data across different devices and populations.

Official Title

Predicting Appendicular Lean and Fat Mass With Bioelectrical Impedance Analysis Among Adult Patients With Obesity.

Quick Facts

Study Start:2021-05-13
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06545435

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults with obesity (BMI ≥ 30 kg/m²)
  2. * Age 18 years and older
  3. * Available baseline DXA and BIA measurements
  4. * Provided informed consent for data use
  1. * any chronic disease or medication that can significantly affect body composition \[eg. malignant diseases in the last 5 years, organ failure, acute inflammation (C-reactive protein\>10 mg/L) autoimmune diseases, neurological diseases, syndromic obesity\]
  2. * cognitive impairment (Mini-Mental State Examination \<25)
  3. * subjects that are considered physically active (athletes or very active subjects i.e., performing at least 150 minutes of moderate to vigorous physical activity per week)
  4. * alcohol intake \>140g/wk for Males and 70g/wk for Females
  5. * participation in a weight-reducing program (last 3 months)
  6. * impossibility to perform DXA exam
  7. * pregnancy and breast-feeding.

Contacts and Locations

Study Contact

Lorenzo M Donini, MD
CONTACT
00390649690215
lorenzomaria.donini@uniroma1.it
Eleonora Poggiogalle, Md, PhD
CONTACT
00390649690215
eleonora.poggiogalle@uniroma1.it

Study Locations (Sites)

Pennington Biomedical Research Center, Louisiana State University
Baton Rouge, Louisiana, 70808
United States
Division of Geriatric Medicine, School of Medicine, and Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
United States

Collaborators and Investigators

Sponsor: University of Roma La Sapienza

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 Registration Dates

Study Start Date2021-05-13
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-05-13
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Appendicular Lean Mass
  • Fat Mass
  • Body Composition
  • Bio-Impedance Analysis

Additional Relevant MeSH Terms

  • Obesity