Magnetic Resonance Imaging and Thermal Imaging of Adiposity in Neonates of Women With Metabolic Diseases
NCT ID: NCT04890886
Last Updated: 2021-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
80 participants
OBSERVATIONAL
2021-06-01
2023-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Physiologic Plasticity of Intramyocardial Lipid Storage
NCT01921075
PED NEONAT 20-000599 Fetal Body Composition
NCT04508751
Measurement of Body Fat in Infants
NCT03490227
Metabolic Effects of Birth Weight on Overweight and Obese Chinese Adults and Their Responses to Weight Loss
NCT01080378
the Fetal Epicardial Thickness in Obese Pregnant Women (EFT)
NCT05948319
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pre-existing Type 1 Diabetes and Type 2 Diabetes
Women with type 1 diabetes and type 2 diabetes diagnosed prior to pregnancy
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
Gestational Diabetes
Women with gestational diabetes diagnosed in pregnancy by the oral glucose tolerance 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
Intrahepatic cholestasis of pregnancy
Women with intrahepatic cholestasis of pregnancy
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
Control
Women without metabolic disease in pregnancy
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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. 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). \[ The mother will not have an MRI scan\].
16 Years
45 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
King's College London
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
287911
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.