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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04508751
Other study ID # 20-000599
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 17, 2020
Est. completion date May 18, 2022

Study information

Verified date October 2022
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Obesity is an ongoing public health problem that is difficult to treat. There is evidence that obesity has fetal origins. Body composition, including visceral, subcutaneous, brown, and hepatic fat have been found to be important predictors in obesity and metabolic syndrome. Magnetic resonance imaging (MRI) can quantify body composition that does not require radiation but is motion limited. The investigators have developed a motion-compensated MRI sequence, also known as "free breathing" MRI. In this study, the investigators plan to obtain free-breathing MRIs of pregnant women in the third trimester of pregnancy. MRIs will be obtained from healthy mothers, mothers with growth-restricted fetuses, and mothers with gestational diabetes. The different types of adipose tissue will be measured and compared between groups and correlated to birth growth parameters. The goal is this study is to assess if motion-compensated MRI can help predict early growth patterns in infancy.


Description:

1.1 OBJECTIVE This study's goals are to: 1) use free-breathing magnetic resonance imaging (FB-MRI) to measure fetal body composition in the third trimester and 2) determine how the FB-MRI quantitative measurements compare to growth parameters at birth. 1.2 HYPOTHESES AND SPECIFIC AIMS To accomplish the investigators' objectives, the aims and hypotheses are as follows: Specific Aim 1: In a prospective study in women with healthy pregnancies and women with fetuses that have intrauterine growth restriction (IUGR) and gestational diabetes, the investigators will quantify fetal subcutaneous, visceral, and brown adipose tissue volumes and proton-density fat fraction (PDFF) using FB-MRI in the third trimester. Hypothesis 1: Using a FB-MRI technique the investigators will find the following, 1. The growth-restricted fetus will have less visceral, subcutaneous, and brown adipose tissue volume and PDFF when compared to healthy fetuses and fetuses whose mothers have gestational diabetes. 2. Fetuses whose mothers have gestational diabetes will have a greater subcutaneous and visceral adipose tissue volume and PDFF compared to healthy fetuses. Specific Aim 2: In a prospective study in pregnant women and their fetuses, the investigators will compare volume and PDFF measurements of fetal visceral, subcutaneous, and brown adipose tissue obtained with FB-MRI to birth growth parameters of these infants. Hypothesis 2: The volume and PDFF of fetal visceral and subcutaneous adipose tissue will correlate positively with birth weight and length z-score.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date May 18, 2022
Est. primary completion date September 27, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pregnant women with singleton pregnancies (healthy cohort) - Pregnant women with fetuses with weights < 10th percentile weight for gestational age (IUGR cohort) - Pregnant women with gestational diabetes (diabetes cohort) Exclusion Criteria: - Pregnant minors - Major congenital anomalies or disease processes in the fetus - Fetus with known chromosomal anomalies - Mothers who do not plan to deliver at UCLA - Multiple pregnancy (i.e. twins, triplets, etc) - History of claustrophobia - Contraindications to MRI such as metallic devices in the body that are not MRI compatible

Study Design


Intervention

Other:
3T "Free-Breathing" Fetal Magnetic Resonance Imaging
Subject will have a one time MRI scan.

Locations

Country Name City State
United States University of California-Los Angeles Los Angeles California
United States University of California- Los Angeles Santa Monica Santa Monica California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maternal Visceral Adipose Tissue Volume MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images and PDFF maps. The FB-MRI radial data will be transferred to a separate workstation for custom reconstruction of 3D fat-water-separated images and PDFF maps and analysis. Visceral adipose tissue PDFF values will be directly measured from regions of interest. During the procedure (MRI)
Primary Fetal Liver PDFF MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images. The distribution/extent of hepatic fat will be manually delineated/drawn on the 3D MRI images and PDFF maps. This work will be performed by PI Strobel with validation from PI Wu. During the procedure (MRI)
Secondary Fetal Subcutaneous Tissue Volume MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images and PDFF maps. The FB-MRI radial data will be transferred to a separate workstation for custom reconstruction of 3D fat-water-separated images and PDFF maps and analysis. Subcutaneous adipose tissue PDFF values will be directly measured from regions of interest. During the procedure (MRI)
Secondary Maternal Subcutaneous Tissue Volume MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images. The distribution/extent of subcutaneous fat will be manually delineated/drawn on the 3D MRI images and PDFF maps and used to calculate volume of subcutaneous adipose tissue. This work will be performed by PI Strobel with validation from PI Wu. During the procedure (MRI)
Secondary Maternal Hepatic Fat PDFF MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images and PDFF maps. The FB-MRI radial data will be transferred to a separate workstation for custom reconstruction of 3D fat-water-separated images and PDFF maps and analysis. Hepatic adipose tissue PDFF values will be directly measured from regions of interest. During the procedure (MRI)
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