Complement and Cardiovascular Risk in Adolescents
CCRIA
1 other identifier
observational
77
1 country
1
Brief Summary
This study evaluates how genetic variations in complement, a part of the immune system, affect cardiovascular risk in adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 29, 2016
CompletedFirst Posted
Study publicly available on registry
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedResults Posted
Study results publicly available
June 11, 2021
CompletedJune 11, 2021
May 1, 2021
2.1 years
June 29, 2016
September 21, 2020
May 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Complement C3 Genotype
Genetic C3F genotype allele presence
Baseline
C4 Copy Number
C4A or C4B gene copy numbers
Baseline
Secondary Outcomes (9)
BMI
Baseline
Waist Circumference
Baseline
Body Fat
Baseline
Endothelial Function
8 min
Vascular Stiffness
baseline
- +4 more secondary outcomes
Study Arms (1)
Healthy Adolescents
Healthy non Hispanic white adolescents
Eligibility Criteria
Healthy adolescents
You may qualify if:
- Healthy adolescents age 12 to 18 years
- Medication free for 2 weeks except oral contraceptives in females
- Non Hispanic white
You may not qualify if:
- Chronic medications except for contraceptives in females.
- History of autoimmune disease either endocrine or connective tissue type
- History of hematologic or renal disease, malignancy or other chronic disease
- Hispanic ethnicity,
- African-American or Asian race
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio State Universitylead
- American Heart Associationcollaborator
Study Sites (1)
Ohio State University
Columbus, Ohio, 43210, United States
Related Publications (1)
Hoffman RP, Copenhaver MM, Zhou D, Yu CY. Oral glucose tolerance response curve predicts disposition index but not other cardiometabolic risk factors in healthy adolescents. J Pediatr Endocrinol Metab. 2021 Apr 5;34(5):599-605. doi: 10.1515/jpem-2020-0619. Print 2021 May 26.
PMID: 33818037DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Hoffman
- Organization
- Nationwide Children's Hospi
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 29, 2016
First Posted
July 1, 2016
Study Start
June 1, 2016
Primary Completion
June 30, 2018
Study Completion
June 30, 2018
Last Updated
June 11, 2021
Results First Posted
June 11, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share
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