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出境医 / 临床实验 / Generation of Prediction Equations for BIA of the Elderly

Generation of Prediction Equations for BIA of the Elderly

Study Description
Brief Summary:

The objective of the study is to develop prediction equations for calculating Fat-Free Mass FFM, Total Body Water TBW, Extracellular Water ECW, Visceral Adipose Tissue VAT, total Skeletal Muscle Mass SMM and segmental SMM in a group of elderly. The prediction equations are based on linear regression analysis between the gold standard reference methods Air Displacement Plethysmography ADP, Dual-energy X-ray Absorptiometry DXA, Magnet Resonance Imaging MRI, Deuterium dilution method (D2O) and Sodium Bromide dilution method (NaBr) on the one hand and bioelectrical impedance measurements on the other hand.

Multi-frequency bioimpedance is measured for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side using the seca mBCA 515 in standing position and the seca mBCA 525 in standing and lying position.


Condition or disease
Healthy Elderly

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Generation of Prediction Equations to Analyze Body Composition of the Elderly Based on Bioelectrical Impedance Analysis (BIA)
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020
Arms and Interventions
Group/Cohort
elderly
150 elderlies (>60 years): community dwelling or living in old
Outcome Measures
Primary Outcome Measures :
  1. BIA 5 and 50 kHz [ Time Frame: 15 minutes ]
    Bioelectrical Impedance of 5 and 50 kHz for one body side

  2. BIA 50 kHz [ Time Frame: 15 minutes ]
    Bioelectrical Impedance of 50 kHz for all 4 extremities

  3. Total body water [ Time Frame: 15 minutes ]
    Total body water (TBW) by deuterium (D2O) dilution

  4. Extracellular water [ Time Frame: 15 minutes ]
    Extracellular water (ECW) by NaBr dilution

  5. Fat-free mass [ Time Frame: 1hour ]
    Fat-free mass by a 4-compartment model based on dual energy x-ray absorption (DXA), air displacement plethysmography (ADP), D2O dilution and weight

  6. Skeletal muscle mass [ Time Frame: 1 hour ]
    Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI)

  7. Visceral adipose tissue [ Time Frame: 1 hour ]
    Visceral adipose tissue (VAT) by magnetic resonance imaging MRI


Secondary Outcome Measures :
  1. Complete BIA [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
whole blood

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
150 elderlies (>60 years): community dwelling or living in old nursing homes
Criteria

Inclusion Criteria:

  • male and female subjects older than 60 years,
  • stable medication (no changes during the past 6 months),
  • subjects need to be able to sign the informed consent and privacy policy

Exclusion Criteria:

  • acute disease
  • intake of diuretics
  • wearing of support stockings
  • edema diagnosed by inspection and palpation of lower limbs
  • paralysis e.g. after a stroke
  • neurodegenerative diseases e.g. ALS
  • tumors in treatment
  • amputation
  • electronic implants e.g. pacemaker
  • under the skin applied injection systems (e.g. insulin pumps or pain pumps)
  • probands who cannot provide an ICF by themselves
  • probands who might be dependent from the sponsor or the investigation site
  • current alcohol abuse
  • active prostheses
  • electronic life-support systems, e.g. artificial heart, artificial lung
  • portable electronic medical devices, e.g. ECG devices or infusion pumps
  • metallic implants
  • cochlea implants und heart valves prothesis (e.g. Starr-Edwards-Prothesis)
  • vessel clips in the brain or medulla applied before 1995
  • defeatable pumps
  • catheter
  • iron or metallic parts in the body (e.g. shard of metal)
  • dental braces
  • magnetic tooth implants
  • not removeable piercings
  • extensive tattoos
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Kristin Klückmann +4940200000 ext 232 Kristin.Klueckmann@seca.com

Locations
Layout table for location information
Germany
Institute of Human Nutrition and Food Science Recruiting
Kiel, Germany, 24105
Contact: Anja Bosy-Westphal, Prof. Dr. Dr.    0049 431 880 ext 5670    abosyw@nutrfoodsc.uni-kiel.de   
Principal Investigator: Anja Bosy-Westphal, Prof. Dr. Dr.         
Sub-Investigator: Wiebke Braun, Dr.         
Sponsors and Collaborators
Seca GmbH & Co. Kg.
Tracking Information
First Submitted Date September 14, 2018
First Posted Date July 22, 2019
Last Update Posted Date July 22, 2019
Actual Study Start Date February 4, 2019
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 19, 2019)
  • BIA 5 and 50 kHz [ Time Frame: 15 minutes ]
    Bioelectrical Impedance of 5 and 50 kHz for one body side
  • BIA 50 kHz [ Time Frame: 15 minutes ]
    Bioelectrical Impedance of 50 kHz for all 4 extremities
  • Total body water [ Time Frame: 15 minutes ]
    Total body water (TBW) by deuterium (D2O) dilution
  • Extracellular water [ Time Frame: 15 minutes ]
    Extracellular water (ECW) by NaBr dilution
  • Fat-free mass [ Time Frame: 1hour ]
    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 [ Time Frame: 1 hour ]
    Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI)
  • Visceral adipose tissue [ Time Frame: 1 hour ]
    Visceral adipose tissue (VAT) by magnetic resonance imaging MRI
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 19, 2019) 		Complete BIA [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Generation of Prediction Equations for BIA of the Elderly
Official Title Generation of Prediction Equations to Analyze Body Composition of the Elderly Based on Bioelectrical Impedance Analysis (BIA)
Brief Summary

The objective of the study is to develop prediction equations for calculating Fat-Free Mass FFM, Total Body Water TBW, Extracellular Water ECW, Visceral Adipose Tissue VAT, total Skeletal Muscle Mass SMM and segmental SMM in a group of elderly. The prediction equations are based on linear regression analysis between the gold standard reference methods Air Displacement Plethysmography ADP, Dual-energy X-ray Absorptiometry DXA, Magnet Resonance Imaging MRI, Deuterium dilution method (D2O) and Sodium Bromide dilution method (NaBr) on the one hand and bioelectrical impedance measurements on the other hand.

Multi-frequency bioimpedance is measured for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side using the seca mBCA 515 in standing position and the seca mBCA 525 in standing and lying position.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
whole blood
Sampling Method Probability Sample
Study Population 150 elderlies (>60 years): community dwelling or living in old nursing homes
Condition Healthy Elderly
Intervention Not Provided
Study Groups/Cohorts elderly
150 elderlies (>60 years): community dwelling or living in old
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 19, 2019) 		150
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 28, 2020
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • male and female subjects older than 60 years,
  • stable medication (no changes during the past 6 months),
  • subjects need to be able to sign the informed consent and privacy policy

Exclusion Criteria:

  • acute disease
  • intake of diuretics
  • wearing of support stockings
  • edema diagnosed by inspection and palpation of lower limbs
  • paralysis e.g. after a stroke
  • neurodegenerative diseases e.g. ALS
  • tumors in treatment
  • amputation
  • electronic implants e.g. pacemaker
  • under the skin applied injection systems (e.g. insulin pumps or pain pumps)
  • probands who cannot provide an ICF by themselves
  • probands who might be dependent from the sponsor or the investigation site
  • current alcohol abuse
  • active prostheses
  • electronic life-support systems, e.g. artificial heart, artificial lung
  • portable electronic medical devices, e.g. ECG devices or infusion pumps
  • metallic implants
  • cochlea implants und heart valves prothesis (e.g. Starr-Edwards-Prothesis)
  • vessel clips in the brain or medulla applied before 1995
  • defeatable pumps
  • catheter
  • iron or metallic parts in the body (e.g. shard of metal)
  • dental braces
  • magnetic tooth implants
  • not removeable piercings
  • extensive tattoos
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Kristin Klückmann +4940200000 ext 232 Kristin.Klueckmann@seca.com
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04028648
Other Study ID Numbers BCA-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
IPD Sharing Statement Not Provided
Responsible Party Seca GmbH & Co. Kg.
Study Sponsor Seca GmbH & Co. Kg.
Collaborators Not Provided
Investigators Not Provided
PRS Account Seca GmbH & Co. Kg.
Verification Date July 2019

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