Magnetic Resonance Imaging and Thermal Imaging of Adiposity in Neonates of Women With Metabolic Diseases
MRI-TIME
1 other identifier
observational
80
0 countries
N/A
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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
Started Jun 2021
Typical duration for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2021
CompletedFirst Posted
Study publicly available on registry
May 18, 2021
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMay 18, 2021
May 1, 2021
2.5 years
May 13, 2021
May 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Assessment of skeletal muscle, heart and liver
30 months
Assessment of the function of adipose tissue
30 months
Assessment of cardiac function and rhythm
30 months
Thermal assessment
30 months
Study Arms (4)
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
Interventions
Use of a thermal imaging cameral to measure brown and white adipose tissue function
Echocardiographic imaging of the fetal heart to assess ventricular function
ECG of the fetus and the neonate to look at the cardiac electrical activity
MRI scan of the neonate to assess adipose tissue, liver architecture and cardiac structure and function
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
Eligibility Criteria
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.
You may qualify if:
- Pregnant women aged between 16 and 45 years old.
- Women with GDM diagnosed at 26+0 to 30+6 weeks' gestation in accordance with the NICE guidelines Or
- Pregnant women with pre-existing type 1 or type 2 diabetes mellitus Or
- Women diagnosed with ICP at any stage of pregnancy
- Fluent in English or presence of an interpreter or translation service (i.e. telephone translation services) at all visits.
- Singleton pregnancy.
- Willing and able to give written informed consent and comply with requirements of the study protocol
- Planned antenatal, intrapartum and postpartum care at the participating centre (i.e. not planning to move before delivery)
You may not qualify if:
- \. Known fetal congenital abnormality on ultrasound requiring fetal medicine input (excluding congenital heart disease).
- Known fetal congenital abnormality on ultrasound requiring fetal medicine input (excluding congenital heart disease).
- 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.
- 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).
- History of bariatric surgery.
- Hypertension requiring treatment pre-pregnancy / in pregnancy.
- Prescribed other medications that affect insulin sensitivity prior to OGTT for women diagnosed with GDM (oral antihyperglycemic agents, antipsychotic drugs, supraphysiological doses of steroids).
- 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). \[ The mother will not have an MRI scan\].
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guy's and St Thomas' NHS Foundation Trustlead
- King's College Londoncollaborator
Biospecimen
Serum samples to measure metabolic function and measures of cardiac function
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2021
First Posted
May 18, 2021
Study Start
June 1, 2021
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
May 18, 2021
Record last verified: 2021-05