Magnetic Resonance Imaging and Thermal Imaging of Adiposity in Neonates of Women With Metabolic Diseases (MRI-TIME)

Guy's and St Thomas' NHS Foundation Trust

Status: Unknown

Conditions: Intrahepatic Cholestasis of Pregnancy; Diabetes Mellitus; Metabolic Disease

Treatments: Diagnostic Test: MRI scan; Diagnostic Test: ECG; Diagnostic Test: Serum blood markers; Diagnostic Test: Thermal imaging; Diagnostic Test: Echocardiogram

Study type: Observational

Funder types: Other

Identifiers

NCT04890886

287911

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

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).

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

3. 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.

4. 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).

5. History of bariatric surgery.

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

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

8. 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].

Trial design

80 participants in 4 patient groups

Pre-existing Type 1 Diabetes and Type 2 Diabetes

Description:

Women with type 1 diabetes and type 2 diabetes diagnosed prior to pregnancy

Treatment:

Diagnostic Test: Thermal imaging

Diagnostic Test: Echocardiogram

Diagnostic Test: MRI scan

Diagnostic Test: ECG

Diagnostic Test: Serum blood markers

Gestational Diabetes

Description:

Women with gestational diabetes diagnosed in pregnancy by the oral glucose tolerance test

Treatment:

Diagnostic Test: Thermal imaging

Diagnostic Test: Echocardiogram

Diagnostic Test: MRI scan

Diagnostic Test: ECG

Diagnostic Test: Serum blood markers

Intrahepatic cholestasis of pregnancy

Description:

Women with intrahepatic cholestasis of pregnancy

Treatment:

Diagnostic Test: Thermal imaging

Diagnostic Test: Echocardiogram

Diagnostic Test: MRI scan

Diagnostic Test: ECG

Diagnostic Test: Serum blood markers

Control

Description:

Women without metabolic disease in pregnancy

Treatment:

Diagnostic Test: Thermal imaging

Diagnostic Test: Echocardiogram

Diagnostic Test: MRI scan

Diagnostic Test: ECG

Diagnostic Test: Serum blood markers