Trial Outcomes & Findings for Complement and Cardiovascular Risk in Adolescents (NCT NCT02821104)

Results Overview

Genetic C3F genotype allele presence

Recruitment status

COMPLETED

Target enrollment

77 participants

Primary outcome timeframe

Baseline

Results posted on

2021-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Adolescents Healthy non-Hispanic white adolescents between 12 and 18 years of age
Overall Study STARTED	77
Overall Study COMPLETED	77
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Complement and Cardiovascular Risk in Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Adolescents n=75 Participants Healthy non-Hispanic white adolescents between 12 and 18 years
Age, Continuous	15.2 years STANDARD_DEVIATION 1.67 • n=99 Participants
Sex: Female, Male Female	34 Participants n=99 Participants
Sex: Female, Male Male	41 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	75 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
BMI	22.0 kg/m^2 STANDARD_DEVIATION 5.8 • n=99 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Total population

Genetic C3F genotype allele presence

Outcome measures

Outcome measures
Measure	Healthy Adolescents n=75 Participants Non Hispanic white
Complement C3 Genotype FS	22 Participants
Complement C3 Genotype SS	45 Participants
Complement C3 Genotype FF	2 Participants
Complement C3 Genotype missing	6 Participants

PRIMARY outcome

Timeframe: Baseline

C4A or C4B gene copy numbers

Outcome measures

Outcome measures
Measure	Healthy Adolescents n=75 Participants Non Hispanic white
C4 Copy Number C4A Copy number · 1	14 Participants
C4 Copy Number C4A Copy number · 2	35 Participants
C4 Copy Number C4A Copy number · 3	15 Participants
C4 Copy Number C4A Copy number · 4	6 Participants
C4 Copy Number C4A Copy number · missing	5 Participants
C4 Copy Number C4A Copy number · 0	0 Participants
C4 Copy Number C4B copy number · 1	20 Participants
C4 Copy Number C4B copy number · 2	45 Participants
C4 Copy Number C4B copy number · 3	3 Participants
C4 Copy Number C4B copy number · 4	0 Participants
C4 Copy Number C4B copy number · missing	5 Participants
C4 Copy Number C4B copy number · 0	2 Participants

SECONDARY outcome

Timeframe: Baseline

Body mass index

Outcome measures

Outcome measures
Measure	Healthy Adolescents n=75 Participants Non Hispanic white
BMI	22.0 kg/m^2 Standard Error 0.7

SECONDARY outcome

Timeframe: Baseline

Waist circumference at narrowest point

Outcome measures

Outcome measures
Measure	Healthy Adolescents n=74 Participants Non Hispanic white
Waist Circumference	72.5 cm Standard Error 1.5

SECONDARY outcome

Timeframe: Baseline

Percent body fat BodPod

Outcome measures

Outcome measures
Measure	Healthy Adolescents n=74 Participants Non Hispanic white
Body Fat	23.9 percentage of total body weight Standard Error 1.2

SECONDARY outcome

Timeframe: 8 min

reactive hyperemia response to upper arm occlusion

Outcome measures

Outcome measures
Measure	Healthy Adolescents n=72 Participants Non Hispanic white
Endothelial Function	-81.7 percentage change from baseline FVR Standard Error 0.9

SECONDARY outcome

Timeframe: baseline

augmentation index of reflected blood pressure wave

Outcome measures

Outcome measures
Measure	Healthy Adolescents n=72 Participants Non Hispanic white
Vascular Stiffness	-3.3 percentage of peak blood pressure Standard Error 2.5

SECONDARY outcome

Timeframe: baseline

Outcome measures

Outcome measures
Measure	Healthy Adolescents n=70 Participants Non Hispanic white
Endothelin 1	2.06 pg/ml Standard Error 0.06

SECONDARY outcome

Timeframe: baseline

IL6

Outcome measures

Outcome measures
Measure	Healthy Adolescents n=70 Participants Non Hispanic white
Inflammation	0.68 mg/ml Standard Error 0.08

SECONDARY outcome

Timeframe: baseline

PAI1

Outcome measures

Outcome measures
Measure	Healthy Adolescents n=70 Participants Non Hispanic white
Clotting	3.78 pg/ml Standard Error 0.32

SECONDARY outcome

Timeframe: baseline

Oral glucose tolerance test

Outcome measures

Outcome measures
Measure	Healthy Adolescents n=69 Participants Non Hispanic white
Insulin Sensitivity	4.25 units Standard Error 0.27

Adverse Events

Healthy Adolescents

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

Robert Hoffman

Nationwide Children's Hospi

Phone: 614-722-4425

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place