NCT04890886

Magnetic Resonance Imaging and Thermal Imaging of Adiposity in Neonates of Women With Metabolic Diseases

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 16 Years – 45 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Diabetes Mellitus
• Intrahepatic Cholestasis of Pregnancy
• Metabolic Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Thermal imaging	Use of a thermal imaging cameral to measure brown and white adipose tissue function
DIAGNOSTIC_TEST	Echocardiogram	Echocardiographic imaging of the fetal heart to assess ventricular function
DIAGNOSTIC_TEST	ECG	ECG of the fetus and the neonate to look at the cardiac electrical activity
DIAGNOSTIC_TEST	MRI scan	MRI scan of the neonate to assess adipose tissue, liver architecture and cardiac structure and function
DIAGNOSTIC_TEST	Serum blood markers	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

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2021-05-18
• Last updated: 2021-05-18