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| Name | Class |
|---|---|
| King's College London | OTHER |
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There is limited knowledge about the extent of the impact of maternal metabolic diseases (MD) and/or alterations in maternal serum lipid content upon neonatal lipid distribution and phenotypes. This observational feasibility study aims to investigate the effect of maternal MD on fat distribution, lipid content and metabolic phenotype of different neonatal tissues. We will explore whether differences in tissue fat distribution and lipid content are observed in the neonates of women with MD during pregnancy, compared to those who have a healthy, uncomplicated pregnancy and if there are changes in how the different tissues work (e.g. cardiac function). If there is evidence to show that there are alterations during pregnancy in children of women with MD, this will help inform potential interventions to ensure optimal child health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-existing Type 1 Diabetes and Type 2 Diabetes | Women with type 1 diabetes and type 2 diabetes diagnosed prior to pregnancy |
| |
| Gestational Diabetes | Women with gestational diabetes diagnosed in pregnancy by the oral glucose tolerance test |
| |
| Intrahepatic cholestasis of pregnancy | Women with intrahepatic cholestasis of pregnancy |
| |
| Control | Women without metabolic disease in pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermal imaging | Diagnostic Test | Use of a thermal imaging cameral to measure brown and white adipose tissue function |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the distribution of adipose tissue | To perform imaging and biochemical studies to determine whether maternal metabolic disease alters the distribution of adipose tissue (SAT, VAT, BAT) of the fetuses and neonates of women with MD during pregnancy compared to neonates of women who had a healthy pregnancy. | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of skeletal muscle, heart and liver | To perform imaging and biochemical studies to determine whether maternal metabolic disease alters the distribution and phenotypes of skeletal muscle, heart and liver of the fetuses and neonates of women with MD during pregnancy compared to those of women who had a healthy pregnancy. | 30 months |
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Inclusion Criteria:
Exclusion Criteria:
1. Known fetal congenital abnormality on ultrasound requiring fetal medicine input (excluding congenital heart disease).
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Pregnant women with metabolic disease in pregnancy or healthy controls.
The neonates that will be studied can be of any sex/gender for inclusion in the study.
IPD will be made available upon reasonable request and final decision from the PI.
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Serum samples to measure metabolic function and measures of cardiac function
| Echocardiogram | Diagnostic Test | Echocardiographic imaging of the fetal heart to assess ventricular function |
|
| ECG | Diagnostic Test | ECG of the fetus and the neonate to look at the cardiac electrical activity |
|
| MRI scan | Diagnostic Test | MRI scan of the neonate to assess adipose tissue, liver architecture and cardiac structure and function |
|
| Serum blood markers | Diagnostic Test | Serum sample taken from mother before birth and umbilical cord or neonatal blood spot at birth to assess glucose levels / lipid levels and lipidomics and cardiac function (using NTproBNP) as a marker |
|
| Assessment of the function of adipose tissue |
To evaluate novel MRI-based techniques to measure the function of adipose tissue (SAT, VAT, BAT) in the neonates. |
| 30 months |
| Assessment of cardiac function and rhythm | To perform echocardiography and fetal/ neonatal ECG studies to understand the impact of maternal MD on the fetal heart. | 30 months |
| Thermal assessment | To use thermal imaging to determine the temperature of regions of interest, e.g. BAT, of pregnant women with MD and their neonates. | 30 months |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| C535932 | Intrahepatic Cholestasis of Pregnancy |
| D008659 | Metabolic Diseases |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D004562 | Electrocardiography |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D004568 | Electrodiagnosis |
| D014054 | Tomography |
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