Trial Outcomes & Findings for Generation of Prediction Equations for BIA of the Elderly (NCT NCT04028648)

NCT ID: NCT04028648

Last Updated: 2022-02-14

Results Overview

Total body water (TBW) by deuterium (D2O) dilution

• Recruitment status: COMPLETED
• Target enrollment: 150 participants
• Primary outcome timeframe: 15 minutes
• Results posted on: 2022-02-14

Participant Flow

Participant milestones

Measure	Elderly 150 elderlies (\>60 years): community dwelling or living in old people's homes.
Overall Study STARTED	150
Overall Study COMPLETED	150
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Elderly n=150 Participants 150 elderlies (\>60 years): community dwelling or living in old
Age, Continuous	70.3 years STANDARD_DEVIATION 5.5 • n=150 Participants
Sex: Female, Male Female	88 Participants n=150 Participants
Sex: Female, Male Male	62 Participants n=150 Participants
weight	74.3 kg STANDARD_DEVIATION 16.3 • n=150 Participants

PRIMARY outcome

Timeframe: 15 minutes

Total body water (TBW) by deuterium (D2O) dilution

Outcome measures

Measure	Elderly n=150 Participants 150 elderlies (\>60 years): community dwelling or living in old
Total Body Water	1.85 liter Standard Deviation 0.11

PRIMARY outcome

Timeframe: 15 minutes

Extracellular water (ECW) by NaBr dilution

Outcome measures

Measure	Elderly n=150 Participants 150 elderlies (\>60 years): community dwelling or living in old
Extracellular Water	0.74 liter Standard Deviation 0.04

PRIMARY outcome

Timeframe: 15 minutes

Fat-free mass by a 4-compartment model based on dual energy x-ray absorption (DXA), air displacement plethysmography (ADP), D2O dilution and weight

Outcome measures

Measure	Elderly n=150 Participants 150 elderlies (\>60 years): community dwelling or living in old
Fat-free Mass	2.20 kg Standard Deviation 0.13

PRIMARY outcome

Timeframe: 1 hour

Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI)

Outcome measures

Measure	Elderly n=150 Participants 150 elderlies (\>60 years): community dwelling or living in old
Skeletal Muscle Mass	2.07 kg Standard Deviation 0.12

PRIMARY outcome

Timeframe: 1 hour

Visceral adipose tissue (VAT) by magnetic resonance imaging MRI

Outcome measures

Measure	Elderly n=150 Participants 150 elderlies (\>60 years): community dwelling or living in old
Visceral Adipose Tissue	0.92 liter Standard Deviation 0.05

Adverse Events

Elderly

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kristin Klückmann

seca gmbh & co. kg

Phone: 040200000232

Email: kristin.klueckmann@seca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place