Plain English Summary
Background and study aims
The aim of this study is to see whether a reduced calorie diet can be used to treat diabetes that develops during pregnancy (gestational diabetes). We know that this treatment can be very successful for people with late-onset (type 2) diabetes; the question is whether it can also be used to treat gestational diabetes. We are also interested in the effects of the diet on the body, in particular the effect on the liver. It is thought that gestational diabetes occurs due to too much fat in the liver. This study looks to see whether liver fat is reduced by diet.
Who can participate?
Pregnant women with gestational diabetes. Gestational diabetes is usually diagnosed after 20 weeks gestation by an oral glucose tolerance test arranged by your NHS midwife or antenatal clinic. Women can enter the study between 20 and 32 weeks gestation.
What does the study involve?
The study involves two visits to the Newcastle Magnetic Resonance Centre. At each visit you will be asked not to eat or drink overnight. You will have a magnetic resonance scan of the liver. This is perfectly safe in pregnancy. You will then be given breakfast (cereal, bread roll, margarine, jam and fruit juice). Blood samples will be taken over the next three hours to measure your body’s response to breakfast. During your first visit you will be seen by a dietician. We will explain how to reduce your calorie intake to 1,200 kcal. Food suggestions, recipes and portion sizes will be discussed in order to give you a balanced diet containing all necessary nutrients. You will be asked to keep a food diary on MyFitnessPal (a smartphone app). We will show you how to do this. The diary is reviewed regularly by one of the research team and we will contact you by text or telephone regularly during the diet. After 4 weeks of dieting you will be asked to return to the Newcastle Magnetic Resonance Centre for a repeat scan of the liver and meal test. We will be able to tell you how much fat you have lost from the liver and see the effect of the diet on your glucose control during the meal.
What are the possible benefits and risks of participating?
The main benefit of the study is an improvement in your glucose control. This is of huge benefit to both you and your baby and reduces the risks associated with gestational diabetes. Additionally, there are benefits of a more healthy weight in terms of reducing pregnancy risks such as blood clots and infection. You will benefit from more intense medical input during your pregnancy. You will gain knowledge about your body during pregnancy and get feedback with regards to the effect of diet on your metabolism. There are no risks of participating in this study.
Where is the study run from?
The study recruits patients from the Obstetric Medicine Antenatal Clinic at the Royal Victoria Infirmary, Newcastle upon Tyne Hospitals Foundation NHS Trust. The study is run at the Newcastle Magnetic Resonance Centre, Newcastle University (UK).
When is the study starting and how long is it expected to run for?
The study starts in January 2015 and is expected to run until August 2015.
Who is funding the study?
The study is funded by a grant from the North East Diabetes Trust (UK).
Who is the main contact?
Dr Ken Hodson
kenneth.hodson@ncl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Kenneth Hodson
ORCID ID
http://orcid.org/0000-0003-3091-6952
Contact details
Newcastle Magnetic Resonance Centre
Campus for Ageing and Vitality
Newcastle University
Newcastle upon Tyne
NE4 5PL
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Dietary intervention for the treatment of gestational diabetes: a magnetic resonance study
Acronym
WELLBABE
Study hypothesis
Calorie restriction in women with gestational diabetes reduces liver fat, thereby improving insulin resistance and improved glycaemic control.
Ethics approval
NRES Committee North East - Newcastle & North Tyneside 2, 22/10/2014, ref: 14/NE/1085
Study design
Interventional non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet.
Condition
Gestational diabetes: hyperglycaemia that is first recognised in pregnancy
Intervention
Dietary intervention: calorie reduction to 1,200 kcal for four weeks.
Magnetic resonance spectroscopy will be used to quantify liver fat before and after a four-week dietary intervention. A standardised meal test will be used to quantify insulin resistance and glycaemic control.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
1. Liver fat – measured at baseline and after 4 weeks of dietary intervention by magnetic resonance spectroscopy
2. Glycaemic control – measured by home blood glucose monitoring in the first and fourth weeks
Secondary outcome measures
1. Insulin/C peptide/glucose response to a standardised meal test. Measured at baseline and after 4 weeks of dietary intervention
2. Lipid profile – measured using nuclear magnetic spectroscopy at baseline and 4 weeks of dietary intervention
3. HBA1c – measured at baseline and after 4 weeks of dietary intervention
4. Feasibility and acceptibility of dietary intervention in pregnancy (qualitative study) – assessed by semi-structured interview after the dietary intervention and analysed using the theory domain framework
Overall trial start date
01/01/2015
Overall trial end date
01/01/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Female
2. Greater than 20 weeks pregnant
3. Gestational diabetes (oral glucose tolerance test greater than/equal to 5.1 mmol/l, or 2-hour glucose greater than/equal to 7.8 mmol/l)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
16
Participant exclusion criteria
Contraindication to MRI:
1. Pacemaker/ferromagnetic implants
2. Metallic fragments in eye
3. Piercings that cannot be removed
4. Claustrophobia
Recruitment start date
05/01/2015
Recruitment end date
01/08/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Newcastle upon Tyne Hospitals NHS Foundation Trust
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
Trial participating centre
Newcastle Magnetic Resonance Centre
Newcastle University Campus for Ageing and Vitality
Newcastle upon Tyne
NE4 5PL
United Kingdom
Funders
Funder type
Charity
Funder name
North East Diabetes Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results from this study will be written up for publication as a scientific paper in an established medical journal. Expected completion and publication will be by August 2016.
Intention to publish date
01/08/2016
Participant level data
Available on request
Results - basic reporting
Publication summary