Clinical trial NCT04890886: Magnetic Resonance Imaging and Thermal Imaging of Adiposity in Neonates of Women With Metabolic Diseases
Official title: Magnetic Resonance Imaging and Thermal Imaging of Adiposity in Neonates of Women With Metabolic Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Intrahepatic Cholestasis of Pregnancy
Metabolic Disease
Keywords: type 1 diabetes
type 2 diabetes
gestational diabetes
intrahepatic cholestasis of pregnancy
metabolic disease in pregnancy
brown adipose tissue
white adipose tissue
cardiac function
ECG
liver function
thermal imaging
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2021-05-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


Eligibility criteria: 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). \[ The mother will not have an MRI scan\].

Primary outcomes:
measure: Assessment of the distribution of adipose tissue
timeFrame: 30 months
Secondary outcomes:
measure: Assessment of skeletal muscle, heart and liver
timeFrame: 30 months
measure: Assessment of the function of adipose tissue
timeFrame: 30 months
measure: Assessment of cardiac function and rhythm
timeFrame: 30 months
measure: Thermal assessment
timeFrame: 30 months
Other outcomes:
Locations:
Study officials:
References: