18 and older, female only, with IUGR or Gestational Diabetes. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maternal Visceral Adipose Tissue VolumePrimary· 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.
Group
Value
95% CI
Healthy Pregnancy
97593
78014 – 121081
Pregnant Mothers With Gestational Diabetes
169626
137736 – 227035
Pregnant Mothers With Infants Diagnosed With IUGR
96787
82327 – 184784
Fetal Liver PDFFPrimary· 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.
Group
Value
95% CI
Healthy Pregnancy
3.2
3.0 – 3.3
Pregnant Mothers With Gestational Diabetes
5.2
4.2 – 5.5
Pregnant Mothers With Infants Diagnosed With IUGR
1.9
1.4 – 3.7
Fetal Subcutaneous Tissue VolumeSecondary· 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.
Group
Value
95% CI
Healthy Pregnancy
241
232 – 255
Pregnant Mothers With Gestational Diabetes
280
261 – 295
Pregnant Mothers With Infants Diagnosed With IUGR
220
205 – 235
Maternal Subcutaneous Tissue VolumeSecondary· 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.
Group
Value
95% CI
Healthy Pregnancy
157319
126300 – 200028
Pregnant Mothers With Gestational Diabetes
216264
161461 – 325975
Pregnant Mothers With Infants Diagnosed With IUGR
159197
84024 – 339707
Maternal Hepatic Fat PDFFSecondary· 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.
Group
Value
95% CI
Healthy Pregnancy
2.1
1.8 – 2.8
Pregnant Mothers With Gestational Diabetes
3.2
2.1 – 3.8
Pregnant Mothers With Infants Diagnosed With IUGR
2.2
1.1 – 5.0
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of California, Los Angeles
Last refreshed: 30 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04508751.