Diabetes MellitusMRI-TIMENCT04890886
Magnetic Resonance Imaging and Thermal Imaging of Adiposity in Neonates of Women With Metabolic Diseases
An observational study of Diabetes Mellitus and Intrahepatic Cholestasis of Pregnancy, run by Guy's and St Thomas' NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Diabetes Mellitus, Intrahepatic Cholestasis of Pregnancy, Metabolic Disease
- What is being tested?
- Thermal imaging, Echocardiogram and ECG
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- Child, Adult
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.
Who may be able to join
- 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)
Who cannot join
- 1. 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].
About this study
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.
- Being tested
- Thermal imaging, Echocardiogram, ECG, MRI scan, Serum blood markers
- 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
- Medical subject headings
- Diabetes Mellitus, Intrahepatic Cholestasis of Pregnancy, Metabolic Diseases, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal imagingDiagnostic test
Use of a thermal imaging cameral to measure brown and white adipose tissue function
EchocardiogramDiagnostic test
Echocardiographic imaging of the fetal heart to assess ventricular function
ECGDiagnostic test
ECG of the fetus and the neonate to look at the cardiac electrical activity
MRI scanDiagnostic test
MRI scan of the neonate to assess adipose tissue, liver architecture and cardiac structure and function
Serum blood markersDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Pre-existing Type 1 Diabetes and Type 2 Diabetes | Women with type 1 diabetes and type 2 diabetes diagnosed prior to pregnancy Receives: Diagnostic Test: Thermal imaging; Diagnostic Test: Echocardiogram; Diagnostic Test: ECG; Diagnostic Test: MRI scan; Diagnostic Test: Serum blood markers | |
| Gestational Diabetes | Women with gestational diabetes diagnosed in pregnancy by the oral glucose tolerance test Receives: Diagnostic Test: Thermal imaging; Diagnostic Test: Echocardiogram; Diagnostic Test: ECG; Diagnostic Test: MRI scan; Diagnostic Test: Serum blood markers | |
| Intrahepatic cholestasis of pregnancy | Women with intrahepatic cholestasis of pregnancy Receives: Diagnostic Test: Thermal imaging; Diagnostic Test: Echocardiogram; Diagnostic Test: ECG; Diagnostic Test: MRI scan; Diagnostic Test: Serum blood markers | |
| Control | Women without metabolic disease in pregnancy Receives: Diagnostic Test: Thermal imaging; Diagnostic Test: Echocardiogram; Diagnostic Test: ECG; Diagnostic Test: MRI scan; Diagnostic Test: Serum blood markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 months
Secondary outcomes (4)
Assessment of skeletal muscle, heart and liver
To perform imaging and biochemical studies to determine whether maternal metabolic disease alters the distribution and phenotypes of skeletal muscle, heart and liver of the fetuses and neonates of women with MD during pregnancy compared to those of women who had a healthy pregnancy.
Measured: 30 months
Assessment of the function of adipose tissue
To evaluate novel MRI-based techniques to measure the function of adipose tissue (SAT, VAT, BAT) in the neonates.
Measured: 30 months
Assessment of cardiac function and rhythm
To perform echocardiography and fetal/ neonatal ECG studies to understand the impact of maternal MD on the fetal heart.
Measured: 30 months
Thermal assessment
To use thermal imaging to determine the temperature of regions of interest, e.g. BAT, of pregnant women with MD and their neonates.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890886
- Sponsor's protocol ID
- 287911
- Acronym
- MRI-TIME
- Status last verified
- May 2021
- First submitted
- 13 May 2021
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be made available upon reasonable request and final decision from the PI.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging and Thermal Imaging of Adiposity in Neonates of Women With Metabolic Diseases
- ClinicalTrials.gov ID
- NCT04890886
- Acronym / sponsor ID
- MRI-TIME / 287911
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pre-existing Type 1 Diabetes and Type 2 Diabetes | – | Diagnostic Test: Thermal imaging, Diagnostic Test: Echocardiogram, Diagnostic Test: ECG, Diagnostic Test: MRI scan, Diagnostic Test: Serum blood markersWomen with type 1 diabetes and type 2 diabetes diagnosed prior to pregnancy |
| Gestational Diabetes | – | Diagnostic Test: Thermal imaging, Diagnostic Test: Echocardiogram, Diagnostic Test: ECG, Diagnostic Test: MRI scan, Diagnostic Test: Serum blood markersWomen with gestational diabetes diagnosed in pregnancy by the oral glucose tolerance test |
| Intrahepatic cholestasis of pregnancy | – | Diagnostic Test: Thermal imaging, Diagnostic Test: Echocardiogram, Diagnostic Test: ECG, Diagnostic Test: MRI scan, Diagnostic Test: Serum blood markersWomen with intrahepatic cholestasis of pregnancy |
| Control | – | Diagnostic Test: Thermal imaging, Diagnostic Test: Echocardiogram, Diagnostic Test: ECG, Diagnostic Test: MRI scan, Diagnostic Test: Serum blood markersWomen without metabolic disease in pregnancy |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 1. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal imagingUse of a thermal imaging cameral to measure brown and white adipose tissue function | Diagnostic test | Control, Gestational Diabetes, Intrahepatic cholestasis of pregnancy, Pre-existing Type 1 Diabetes and Type 2 Diabetes |
| EchocardiogramEchocardiographic imaging of the fetal heart to assess ventricular function | Diagnostic test | Control, Gestational Diabetes, Intrahepatic cholestasis of pregnancy, Pre-existing Type 1 Diabetes and Type 2 Diabetes |
| ECGECG of the fetus and the neonate to look at the cardiac electrical activity | Diagnostic test | Control, Gestational Diabetes, Intrahepatic cholestasis of pregnancy, Pre-existing Type 1 Diabetes and Type 2 Diabetes |
| MRI scanMRI scan of the neonate to assess adipose tissue, liver architecture and cardiac structure and function | Diagnostic test | Control, Gestational Diabetes, Intrahepatic cholestasis of pregnancy, Pre-existing Type 1 Diabetes and Type 2 Diabetes |
| Serum blood markersSerum 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 | Diagnostic test | Control, Gestational Diabetes, Intrahepatic cholestasis of pregnancy, Pre-existing Type 1 Diabetes and Type 2 Diabetes |
Primary outcome
Assessment of the distribution of adipose tissue
Time frame: 30 months
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.
4 secondary outcomes
Assessment of skeletal muscle, heart and liver
Time frame: 30 months
Assessment of the function of adipose tissue
Time frame: 30 months
Assessment of cardiac function and rhythm
Time frame: 30 months
Thermal assessment
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Individual participant dataSharing planned: Undecided. IPD will be made available upon reasonable request and final decision from the PI.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Intrahepatic Cholestasis of Pregnancy, run by Guy's and St Thomas' NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the distribution of adipose tissue (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.