Gestational DiabetesFLiP-GD2NCT04362540
Is Fat in the Liver a Marker of Post-Pregnancy Glycaemic Deterioration in Women With Gestational Diabetes?
An observational study of Gestational Diabetes, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to utilise ultrasound, using an established method for detecting NAFLD, to determine whether the presence of NAFLD in women with GDM, detected during routine scanning, is a marker of deterioration in glycaemic status post-partum. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- MRI scan
- Type of treatment
- Pill or oral medicine
- How many people
- 189 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 May 2019to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women with GDM as defined in routine practice, using standard oral glucose tolerance testing (OGTT). Women with confirmed GDM will be classified as either NAFLD-positive or NAFLD-negative on the basis of postpartum MRI scan.
Who may be able to join
- Aged 18 and over
- Pregnant women diagnosed with GDM based on OGTT
Who cannot join
- Women with known type 1 or type 2 diabetes prior to pregnancy
- Women with known history of liver disease including alcoholic liver disease
- Women unable or unwilling to consent to be part of the study
- Women with contraindication to MRI
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, ST4 6QG
About this study
The aim of this study is to utilise ultrasound, using an established method for detecting NAFLD, to determine whether the presence of NAFLD in women with GDM, detected during routine scanning, is a marker of deterioration in glycaemic status post-partum. We propose to assess the relationship between NAFLD and surrogates for insulin resistance as well as glycaemic status, insulin sensitivity and β-cell function, after delivery.
The study is not seeking to compare the incidence of T2DM between those with and without NAFLD. This would require a longer follow-up and larger cohort size. Instead, it aims to quantify the degree of early deterioration of glycaemic status in these groups using insulin resistance markers. This is a clinically important issue as a greater level of insulin resistance would in itself trigger clinical intervention, including vigilant follow-up and empowerment for proactive healthy life style changes, which have been shown to prevent diabetes development .
- Conditions
- Gestational Diabetes
- Being tested
- MRI scan
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanDiagnostic test
Also called OGTT, ELF, Ultrasound, Metabolic Profile
On attendance to antenatal clinic with confirmed diagnosis of gestational diabetes based on OGTT and following informed consent: Ultrasound scan: Those with positive OGTT results (i.e. GDM positive) will attend an appointment for an ultrasound scan, as per routine practice. These women will,at that appointment, be assessed for presence/absence of NAFLD as well as undergoing their routine foetal assessment. This is a simple addendum to the existing scan, taking no more than 5 minutes. Participants will have been informed during the consent process that the results (regarding the presence / absence of NAFLD) will be compared to MRI after delivery.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with GDM | Ultrasound liver scan in addition to routine foetal assessment (antenatal) Metabolic profile blood tests, Oral Glucose Tolerance Test, ELF blood test, repeat liver ultrasound scan and MRI scan (post partum) Receives: Diagnostic Test: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure for the study will be the mean difference in values of the HOMA-IR (as a surrogate for insulin resistance) in those with NAFLD vs. those without NAFLD 6-12 weeks post partum
To determine whether the presence of NAFLD during pregnancy in women with gestational diabetes mellitus is a marker of worse metabolic profile (insulin resistance).
Measured: 6-12 weeks post partum
Secondary outcomes (13)
Comparison of HbA1c and fasting glucose (standard markers of dysglycaemia) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Measured: 6-12 weeks post partum
Comparison of disposition index (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Measured: 6-12 weeks post partum
Comparison of QUICKI (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Measured: 6-12 weeks post partum
Comparison of insulin and nonesterified fatty acid levels (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Measured: 6-12 weeks post partum
Comparison of fasting levels from a 4 point OGTT (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Measured: 6-12 weeks post partum
Comparison of area-under-the-curve from 4 point OGTT (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Measured: 6-12 weeks post partum
Comparison of ELF blood test results (advanced marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Measured: 6-12 weeks post partum
Comparison of liver function tests (as part of the Fatty Liver Index) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Measured: 6-12 weeks post partum
Comparison of Body Mass Index (as part of the Fatty Liver Index) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Measured: 6-12 weeks post partum
Comparison of waist circumference (as part of the Fatty Liver Index) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Measured: 6-12 weeks post partum
Comparison of alcohol history in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Measured: 6-12 weeks post partum
The presence of fat in the liver using a liver ultrasound scan at baseline and 6-12 weeks post partum.
Measured: 6-12 weeks post partum
MRI scan to confirm the presence of NAFLD at 6-12 weeks post partum.
Measured: 6-12 weeks post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start5 May 2019
- Primary completion30 Jun 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- 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
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes UK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362540
- Sponsor's protocol ID
- 214643
- Acronym
- FLiP-GD2
- Status last verified
- Mar 2026
- First submitted
- 14 Feb 2020
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Fat in the Liver a Marker of Post-Pregnancy Glycaemic Deterioration in Women With Gestational Diabetes?
- ClinicalTrials.gov ID
- NCT04362540
- Acronym / sponsor ID
- FLiP-GD2 / 214643
- Conditions
- Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 189 participants (actual)
- Lead sponsor
- University Hospitals of North Midlands NHS TrustUniversity, hospital or other
- Collaborators
- Diabetes UK
- Study start
- 5 May 2019 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 27 Apr 2020 (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.
The aim of this study is to utilise ultrasound, using an established method for detecting NAFLD, to determine whether the presence of NAFLD in women with GDM, detected during routine scanning, is a marker of deterioration in glycaemic status post-partum. We propose to assess the relationship between NAFLD and surrogates for insulin resistance as well as glycaemic status, insulin sensitivity and β-cell function, after delivery.
The study is not seeking to compare the incidence of T2DM between those with and without NAFLD. This would require a longer follow-up and larger cohort size. Instead, it aims to quantify the degree of early deterioration of glycaemic status in these groups using insulin resistance markers. This is a clinically important issue as a greater level of insulin resistance would in itself trigger clinical intervention, including vigilant follow-up and empowerment for proactive healthy life style changes, which have been shown to prevent diabetes development .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with GDM | – | Diagnostic Test: MRI scanUltrasound liver scan in addition to routine foetal assessment (antenatal) Metabolic profile blood tests, Oral Glucose Tolerance Test, ELF blood test, repeat liver ultrasound scan and MRI scan (post partum) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with GDM as defined in routine practice, using standard oral glucose tolerance testing (OGTT). Women with confirmed GDM will be classified as either NAFLD-positive or NAFLD-negative on the basis of postpartum MRI scan.
Key inclusion criteria (2 listed)
- Aged 18 and over
- Pregnant women diagnosed with GDM based on OGTT
Key exclusion criteria (4 listed)
- Women with known type 1 or type 2 diabetes prior to pregnancy
- Women with known history of liver disease including alcoholic liver disease
- Women unable or unwilling to consent to be part of the study
- Women with contraindication to MRI
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 |
|---|---|---|
| MRI scanAlso: OGTT, ELF, Ultrasound, Metabolic ProfileOn attendance to antenatal clinic with confirmed diagnosis of gestational diabetes based on OGTT and following informed consent: Ultrasound scan: Those with positive OGTT results (i.e. GDM positive) will attend an appointment for an ultrasound scan, as per routine practice. These women will,at that appointment, be assessed for presence/absence of NAFLD as well as undergoing their routine foetal assessment. This is a simple addendum to the existing scan, taking no more than 5 minutes. Participants will have been informed during the consent process that the results (regarding the presence / absence of NAFLD) will be compared to MRI after delivery. | Diagnostic test | Pregnant women with GDM |
Primary outcome
The primary outcome measure for the study will be the mean difference in values of the HOMA-IR (as a surrogate for insulin resistance) in those with NAFLD vs. those without NAFLD 6-12 weeks post partum
Time frame: 6-12 weeks post partum
To determine whether the presence of NAFLD during pregnancy in women with gestational diabetes mellitus is a marker of worse metabolic profile (insulin resistance).
13 secondary outcomes
Comparison of HbA1c and fasting glucose (standard markers of dysglycaemia) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Time frame: 6-12 weeks post partum
Comparison of disposition index (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Time frame: 6-12 weeks post partum
Comparison of QUICKI (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Time frame: 6-12 weeks post partum
Comparison of insulin and nonesterified fatty acid levels (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Time frame: 6-12 weeks post partum
Comparison of fasting levels from a 4 point OGTT (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Time frame: 6-12 weeks post partum
Comparison of area-under-the-curve from 4 point OGTT (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Time frame: 6-12 weeks post partum
Comparison of ELF blood test results (advanced marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Time frame: 6-12 weeks post partum
Comparison of liver function tests (as part of the Fatty Liver Index) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Time frame: 6-12 weeks post partum
Comparison of Body Mass Index (as part of the Fatty Liver Index) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Time frame: 6-12 weeks post partum
Comparison of waist circumference (as part of the Fatty Liver Index) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Time frame: 6-12 weeks post partum
Comparison of alcohol history in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
Time frame: 6-12 weeks post partum
The presence of fat in the liver using a liver ultrasound scan at baseline and 6-12 weeks post partum.
Time frame: 6-12 weeks post partum
MRI scan to confirm the presence of NAFLD at 6-12 weeks post partum.
Time frame: 6-12 weeks post partum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
The primary outcome measure for the study will be the mean difference in values of the HOMA-IR (as a surrogate for insulin resistance) in those with NAFLD vs. those without NAFLD 6-12 weeks post partum (time frame: 6-12 weeks post partum). 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 30 Mar 2026.