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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06545435




Registration number
NCT06545435
Ethics application status
Date submitted
5/08/2024
Date registered
9/08/2024
Date last updated
26/08/2024

Titles & IDs
Public title
Predicting Appendicular Lean and Fat Mass With Bioelectrical Impedance Analysis Among Adult Patients With Obesity.
Scientific title
Predicting Appendicular Lean and Fat Mass With Bioelectrical Impedance Analysis Among Adult Patients With Obesity.
Secondary ID [1] 0 0
0606/2021
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Obese Adults Cohort - This cohort includes Caucasian adult subjects with obesity (BMI = 30 kg/m²). Participants have undergone baseline assessments using both Dual X-ray Absorptiometry (DXA) and Bioelectrical Impedance Analysis (BIA).

MRI Validation Subset - A subset of participants from the Obese Adults Cohort selected for additional validation using Magnetic Resonance Imaging (MRI) to assess muscle size and architecture.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Development and Cross-Validation of BIA Equations for Appendicular Soft Tissue Masses
Timepoint [1] 0 0
Baseline
Secondary outcome [1] 0 0
Comparison of New BIA Equations with Existing Models
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Algorithm Development for Conversion Between BIA Devices
Timepoint [2] 0 0
Baseline
Secondary outcome [3] 0 0
Cross-Validation of New BIA Equations with Different DXA Systems
Timepoint [3] 0 0
Baseline
Secondary outcome [4] 0 0
Validation of BIA Equations Using Magnetic Resonance Imaging (MRI)
Timepoint [4] 0 0
Baseline

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Curtin University, School of Population Health - Perth
Recruitment postcode(s) [1] 0 0
6102 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Louisiana
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
Brazil
State/province [3] 0 0
Rio Grande Do Sul
Country [4] 0 0
Canada
State/province [4] 0 0
Alberta
Country [5] 0 0
Italy
State/province [5] 0 0
Cagliari
Country [6] 0 0
Italy
State/province [6] 0 0
Roma
Country [7] 0 0
Italy
State/province [7] 0 0
Trieste
Country [8] 0 0
Portugal
State/province [8] 0 0
Lisboa

Funding & Sponsors
Primary sponsor type
Other
Name
University of Roma La Sapienza
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Trieste
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of North Carolina, Chapel Hill
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Federal University of Pelotas
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Louisiana State University Health Sciences Center in New Orleans
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of Cagliari
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University of Lisbon
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
University of Alberta
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Curtin University
Address [8] 0 0
Country [8] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06545435
Trial related presentations / publications
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Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.
Hamilton-James K, Collet TH, Pichard C, Genton L, Dupertuis YM. Precision and accuracy of bioelectrical impedance analysis devices in supine versus standing position with or without retractable handle in Caucasian subjects. Clin Nutr ESPEN. 2021 Oct;45:267-274. doi: 10.1016/j.clnesp.2021.08.010. Epub 2021 Sep 6.
Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.
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Kyle UG, Genton L, Hans D, Pichard C. Validation of a bioelectrical impedance analysis equation to predict appendicular skeletal muscle mass (ASMM). Clin Nutr. 2003 Dec;22(6):537-43. doi: 10.1016/s0261-5614(03)00048-7.
Lohman, T.G., Roche, A.F. and Martorell, R. (1988) Anthropometric standardization reference manual. Human Kinetics Books, Chicago.
Poggiogalle E, Mendes I, Ong B, Prado CM, Mocciaro G, Mazidi M, Lubrano C, Lenzi A, Donini LM, Siervo M. Sarcopenic obesity and insulin resistance: Application of novel body composition models. Nutrition. 2020 Jul-Aug;75-76:110765. doi: 10.1016/j.nut.2020.110765. Epub 2020 Feb 13.
Prado CM, Siervo M, Mire E, Heymsfield SB, Stephan BC, Broyles S, Smith SR, Wells JC, Katzmarzyk PT. A population-based approach to define body-composition phenotypes. Am J Clin Nutr. 2014 Jun;99(6):1369-77. doi: 10.3945/ajcn.113.078576. Epub 2014 Apr 23. Erratum In: Am J Clin Nutr. 2016 Apr;103(4):1190. doi: 10.3945/ajcn.116.130823.
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Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lorenzo M Donini, MD
Address 0 0
Country 0 0
Phone 0 0
00390649690215
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06545435