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

Brief Title

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

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.
    



Study Type

Observational


Primary Outcome

Assessment of the distribution of adipose tissue

Secondary Outcome

 Assessment of skeletal muscle, heart and liver

Condition

Diabetes Mellitus

Intervention

Thermal imaging

Study Arms / Comparison Groups

 Pre-existing Type 1 Diabetes and Type 2 Diabetes
Description:  Women with type 1 diabetes and type 2 diabetes diagnosed prior to pregnancy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

80

Start Date

June 1, 2021

Completion Date

December 1, 2023

Primary Completion Date

December 1, 2023

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].
      

Gender

Female

Ages

16 Years - 45 Years


Contacts

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Administrative Informations


NCT ID

NCT04890886

Organization ID

287911


Responsible Party

Sponsor

Study Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

 King's College London

Study Sponsor

, , 


Verification Date

May 2021