Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03764878 |
| Other study ID # |
EH18-300 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 29, 2018 |
| Est. completion date |
June 1, 2020 |
Study information
| Verified date |
May 2023 |
| Source |
NorthShore University HealthSystem |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The objective of this study is to evaluate functional MRI as a tool to study placental
transfer of oxygen and nutrients during the third trimester of pregnancy in obese women,
women with pregestational diabetes and healthy low risk women without these conditions
(controls). The investigators hypothesize that altered placental function, including
diminished placental oxygenation and enhanced placental transport of lipids and metabolites
will be seen in obese and pregestational diabetics as compared to controls.
Description:
In this study, we propose to utilize two novel and innovative non-invasive tools to measure
placental oxygenation and lipid and nutrient transport in vivo in women who are obese (OB),
have pregestational diabetes (DM) or have neither (controls). To evaluate differences in
placental oxygenation, we propose to use Blood Oxygen Level Depending (BOLD) imaging, a
method of functional magnetic resonance imaging, to measure tissue oxygenation in the
placenta during the third trimester of pregnancy. To evaluate placental lipid and nutrient
content, we propose to utilize Magnetic Resonance Spectroscopy (MRS), a novel and powerful
tool to compare lipid and nutrient transport across the placenta among OB, DM and controls.
To confirm in vivo BOLD and MRS findings, we will extensively evaluate the placental lipid
content and lipid transport capability. Fatty acid transport protein-4 (FATP-4), one of 6
FATP proteins, is important for placental lipid accumulation, especially LC-PUFA21-24.
Docosahexaenoic acid (DHA) is a crucial LC-PUFA for neurogenesis in early development18.
Major facilitator super family domain containing MFSD2a is a lysophospholipid transporter
required for DHA uptake in the brain and has been linked to placental DHA transfer. Lipid
content of the placenta can be assessed by visualizing lipid droplets via perilipin 2, the
most abundant structural protein on the surface of lipid droplets of adipocytes.
We hypothesize that altered placental function including diminished placental oxygenation and
abnormal placental transport of lipids and other metabolites will be seen in OB and DM women
as compared to controls. We further hypothesize that ex vivo placental pathologic, histologic
and immunohistochemistry characteristics will be associated with in vivo findings. Our
findings from this pilot study have the potential to serve as the basis of a larger study to
further evaluate the potential impact of BOLD and MRS technology on our understanding of
placental lipid and oxygen transport among women with obesity and pregestational diabetes as
compared to women without these conditions.
