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

Diabetes Mellitus Clinical Trial

— MRI-TIME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04890886
• Other study ID #: 287911
• Status: Not yet recruiting
• Start date: June 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2021
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Pregnant women aged between 16 and 45 years old.

2. Women with GDM diagnosed at 26+0 to 30+6 weeks' gestation in accordance with the NICE guidelines Or

3. Pregnant women with pre-existing type 1 or type 2 diabetes mellitus Or

4. Women diagnosed with ICP at any stage of pregnancy

5. Fluent in English or presence of an interpreter or translation service (i.e. telephone translation services) at all visits.

6. Singleton pregnancy.

7. Willing and able to give written informed consent and comply with requirements of the study protocol

8. Planned antenatal, intrapartum and postpartum care at the participating centre (i.e. not planning to move before delivery)

Exclusion Criteria:

1. Known fetal congenital abnormality on ultrasound requiring fetal medicine input (excluding congenital heart disease).

1. Known fetal congenital abnormality on ultrasound requiring fetal medicine input (excluding congenital heart disease).

2. Significant pre-pregnancy co-morbidities that increase risk in pregnancy, for example renal failure, severe liver disease, transplantation, cardiac failure, psychiatric conditions requiring in-patient admission (within previous year) in the opinion of the responsible clinician or the CI.

3. Significant co-morbidity in the current pregnancy, nephropathy (estimated GFR <60ml/min), other physical or psychological conditions likely to interfere with the conduct of the study and/or interpretation of the study results in the opinion of the responsible clinician or the CI. (This does not include diabetes mellitus).

4. History of bariatric surgery.

5. Hypertension requiring treatment pre-pregnancy / in pregnancy.

6. Prescribed other medications that affect insulin sensitivity prior to OGTT for women diagnosed with GDM (oral antihyperglycemic agents, antipsychotic drugs, supraphysiological doses of steroids).

7. For the baby after birth: Not meeting the safety criteria to undergo MRI scan (e.g. metal implants, non MRI compatible devices, metal fragments in the body). [ The mother will not have an MRI scan].

Related Conditions & MeSH terms

• Cholestasis
• Cholestasis, Intrahepatic
• Diabetes Mellitus
• Intrahepatic Cholestasis of Pregnancy
• Metabolic Disease
• Metabolic Diseases
• Pregnancy Complications

Intervention

Diagnostic Test:
• Thermal imaging
Use of a thermal imaging cameral to measure brown and white adipose tissue function
• Echocardiogram
Echocardiographic imaging of the fetal heart to assess ventricular function
• ECG
ECG of the fetus and the neonate to look at the cardiac electrical activity
• MRI scan
MRI scan of the neonate to assess adipose tissue, liver architecture and cardiac structure and function
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	King's College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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