- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04362540
Is Fat in the Liver a Marker of Post-Pregnancy Glycaemic Deterioration in Women With Gestational Diabetes? (FLiP-GD2)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Robert Bowler
- Phone Number: 671939 01782
- Email: robert.bowler@uhnm.nhs.uk
Study Contact Backup
- Name: Keira Watts
- Phone Number: 675385 01782
- Email: keira.watts@uhnm.nhs.uk
Study Locations
-
-
Staffordshire
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Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
- Recruiting
- University Hospitals of North Midlands NHS Trust
-
Contact:
- Callam Weldon
- Phone Number: 75383 017826
- Email: callam.weldon@uhnm.nhs.uk
-
Contact:
- Lucy O'Mara
- Phone Number: 75380 017826
- Email: lucy.omara@uhnm.nhs.uk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 18 and over
- Pregnant women diagnosed with GDM based on OGTT
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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)
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
6-12 weeks post partum
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
6-12 weeks post partum
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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
|
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
|
6-12 weeks post partum
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 214643 (Other Identifier: IRAS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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