Gestational Diabetes, IUGR, Pregnancy Related
Conditions
Brief 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.
Detailed 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.
Interventions
OTHER3T Free-Breathing Fetal Magnetic Resonance Imaging
Subject will have a one time MRI scan.
Sponsors
University of California, Los Angeles
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Pregnant mothers who's infants were diagnosed with intrauterine growth restriction and mothers with pregnancies complicated by gestational diabetes, and mothers with healthy uncomplicated pregnancies will be recruited to have a fetal MRI in the third trimester.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Visceral Adipose Tissue Volume | During the procedure (MRI) | 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. |
| Fetal Liver PDFF | During the procedure (MRI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fetal Subcutaneous Tissue Volume | During the procedure (MRI) | 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. |
| Maternal Subcutaneous Tissue Volume | During the procedure (MRI) | 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. |
| Maternal Hepatic Fat PDFF | During the procedure (MRI) | 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. |
Countries
United States
Participant flow
Recruitment details
Recruited by study investigator or obstetrician through medical clinic.
Pre-assignment details
One subject was excluded due to inability to schedule MRI scan
Participants by arm
| Arm | Count |
|---|---|
| Healthy Pregnancy Pregnancy without fetal anatomic or chromosomal abnormalities, FGR, or GDM. | 10 |
| Pregnant Mothers With Gestational Diabetes GDM was defined as a positive glucola screen at 26 to 32 weeks gestation. | 5 |
| Pregnant Mothers With Infants Diagnosed With IUGR IUGR was defined as fetal weight and abdominal circumference \<10th percentile on ultrasound for a given gestational age or per obstetrician documentation on at least two medical notes | 5 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Discontinued study early due to maternal discomfort | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Healthy Pregnancy | Pregnant Mothers With Gestational Diabetes | Pregnant Mothers With Infants Diagnosed With IUGR | Total |
|---|---|---|---|---|
| Age, Continuous | 34.5 years | 33 years | 35 years | 34.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 1 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 1 Participants | 4 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Glucose tolerance test at 1 hour | 87 mg/dL | 182 mg/dL | 131 mg/dL | 109 mg/dL |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 5 Participants | 3 Participants | 15 Participants |
| Region of Enrollment United States | 10 participants | 5 participants | 5 participants | 20 participants |
| Sex: Female, Male Female | 10 Participants | 5 Participants | 5 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 10 | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 10 | 0 / 5 | 0 / 5 |
Outcome results
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.
Time frame: During the procedure (MRI)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Pregnancy | Fetal Liver PDFF | 3.2 percentage of triglycerides/ |
| Pregnant Mothers With Gestational Diabetes | Fetal Liver PDFF | 5.2 percentage of triglycerides/ |
| Pregnant Mothers With Infants Diagnosed With IUGR | Fetal Liver PDFF | 1.9 percentage of triglycerides/ |
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.
Time frame: During the procedure (MRI)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Pregnancy | Maternal Visceral Adipose Tissue Volume | 97593 mm3 |
| Pregnant Mothers With Gestational Diabetes | Maternal Visceral Adipose Tissue Volume | 169626 mm3 |
| Pregnant Mothers With Infants Diagnosed With IUGR | Maternal Visceral Adipose Tissue Volume | 96787 mm3 |
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.
Time frame: During the procedure (MRI)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Pregnancy | Fetal Subcutaneous Tissue Volume | 241 mm3 |
| Pregnant Mothers With Gestational Diabetes | Fetal Subcutaneous Tissue Volume | 280 mm3 |
| Pregnant Mothers With Infants Diagnosed With IUGR | Fetal Subcutaneous Tissue Volume | 220 mm3 |
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.
Time frame: During the procedure (MRI)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Pregnancy | Maternal Hepatic Fat PDFF | 2.1 % triglycerides |
| Pregnant Mothers With Gestational Diabetes | Maternal Hepatic Fat PDFF | 3.2 % triglycerides |
| Pregnant Mothers With Infants Diagnosed With IUGR | Maternal Hepatic Fat PDFF | 2.2 % triglycerides |
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.
Time frame: During the procedure (MRI)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Pregnancy | Maternal Subcutaneous Tissue Volume | 157319 mm3 |
| Pregnant Mothers With Gestational Diabetes | Maternal Subcutaneous Tissue Volume | 216264 mm3 |
| Pregnant Mothers With Infants Diagnosed With IUGR | Maternal Subcutaneous Tissue Volume | 159197 mm3 |