Generation of Prediction Equations to Analyze Body Composition of Obese Adults Based on BIA

Generation of Prediction Equations to Analyze Body Composition of Obese Adults Based on Bioelectrical Impedance Analysis (BIA)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03779932

Enrollment

Registered

2018-12-19

Start date

2015-02-23

Completion date

2016-02-24

Last updated

2019-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioelectrical Impedance Measurement of Healthy Adults

Brief summary

The study was based on the clinical trial BCA-01 (NCT01368640) Generation of prediction equations to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA) and implicates an extension of the study collective. Aim of the study is to develop prediction equations for calculating FFM, TBW, ECW and SMM based on the gold standard reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA devices on the other hand.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Inclusion criteria

* healthy adults in an * age range of 18 to 65 years * BMI \> 30 kg/m2

Exclusion criteria

* acute and chronic diseases * regular intake of medications (except for contraceptives) * amputation of limbs * electrical implant as cardiac pacemaker * insulin pumps * artificial joints * metallic implants (except tooth implants) * claustrophobia * pregnancy or breastfeeding period * probands who cannot provide an ICF by themselves * probands who might be dependent from the sponsor or the inv. site * current alcohol abuse * frequent hypersensitivity reactions/allergies determ. anamnestically * extensive tattoos at arms or legs

Design outcomes

Primary

Measure	Time frame	Description
Visceral adipose tissue	1 hour	Visceral adipose tissue VAT by magnetic resonance imaging (MRI)
BIA 5 and 50 kHz	15 minutes	Bioelectrical Impedance of 5 and 50 kHz for one body side
BIA 50 kHz	15 minutes	Bioelectrical Impedance of 50 kHz for all 4 extremities
Total body water	15 minutes	Total body water (TBW) by deuterium (D2O) dilution
Extracellular water	15 minutes	Extracellular water (ECW) by NaBr dilution
Fat-free mass	1 hour	Fat-free mass by a 4-compartment model based on dual energy x-ray absorption (DXA), air displacement plethysmography (ADP), D2O dilution and weight
Skeletal muscle mass	1 hour	Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI)

Secondary

Measure	Time frame	Description
Complete BIA	15 minutes	Bioelectrical Impedance of 1, 1.5, 2, 3, 7.5, 10, 15, 20, 30, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side.

Countries

Germany

Outcome results