NCT04279704

Brief Summary

Background Cardiovascular disease is the leading cause of death in the U.S., however scientists have failed to learn fully what are the causes of this disease. A promising lead in understanding the origins of cardiovascular disease may be in gene expression changes occurring in utero in response to environmental (non-genetic) factors. Such changes govern whether a gene is turned on or turned off during an individual's lifetime. Twin pregnancies and twin infants help researchers to have a better understanding of whether the gene expression changes are genetic or environmental in origin. Therefore, the purpose of this project is to examine which body tissues (such as hair, fingernails, urine or blood) are needed to accurately study how gene activity is affected by prenatal factors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2016

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

3.5 years

First QC Date

January 30, 2020

Last Update Submit

October 27, 2020

Conditions

Cardiovascular Risk Factor

Keywords

Metastable epiallelesMonozygoticEpigeneticTwinsDNA methylationGenetic

Outcome Measures

Primary Outcomes (1)

  • DNA methylations

    Percent DNA methylations at metastable epialleles for each sample (urine, finger nails, peripheral blood cells, hair follicles and buccal swab).

    1 hour

Eligibility Criteria

Age1 Month - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Study population include preterm and full term infants who are monozygotic twins newborn to six months of age, recruited from Texas Children's Hospital, Houston.

You may qualify if:

  • Monozygotic (preterm or full term) twin infants.

You may not qualify if:

  • Infants with major congenital anomalies. Infants from higher birth order (e.g. triplets etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexis C Wood

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

The following biospecimens will be collected for DNA isolation and measure DNA methylation of metastable epialleles (MEs) related to cardiovascular diseases. 1. Hair Follicles 2. Peripheral blood cells 3. Finger nails 4. Buccal Swabs 5. Urine

Study Officials

  • Alexis C Wood, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 21, 2020

Study Start

September 1, 2016

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

October 28, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)