NCT06545435 · University of Roma La Sapienza
Predicting Appendicular Lean and Fat Mass With Bioelectrical Impedance Analysis Among Adult Patients With Obesity.
What this study is about
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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adults with obesity (BMI ≥ 30 kg/m²)
- Age 18 years and older
- Available baseline DXA and BIA measurements
- Provided informed consent for data use
Exclusion criteria
- any chronic disease or medication that can significantly affect body composition \[eg. malignant diseases in the last 5 years, organ failure, acute inflammation (C-reactive protein\>10 mg/L) autoimmune diseases, neurological diseases, syndromic obesity\]
- cognitive impairment (Mini-Mental State Examination \<25)
- 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)
- alcohol intake \>140g/wk for Males and 70g/wk for Females
- participation in a weight-reducing program (last 3 months)
- impossibility to perform DXA exam
- pregnancy and breast-feeding.
Where
- Baton Rouge, Louisiana
- Chapel Hill, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 26, 2024 · Source of record for eligibility and locations