At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Visit 1: Protein/fat then carbohydrate. Visit 2: Carbohydrate then protein/fat. (other), Visit 1: Carbohydrate then protein/fat. Visit 2: Protein/fat then carbohydrate. (other)
- How long the study runs
- Study runs about 14 months (dates as stated)
- About the drug or intervention
- Visit 1: Protein/fat then carbohydrate. Visit 2: Carbohydrate then protein/fat. — other: Participants who are randomised to eat the protein/fat-based component (scrambled egg) of the meal before the carbohydrate-based component (wholemeal toast) on their first study visit, will be asked to eat the meal in the reverse order at their second study visit. · Visit 1: Carbohydrate then protein/fat. Visit 2: Protein/fat then carbohydrate. — other: Participants who are randomised to eat the carbohydrate-based component (wholemeal toast) of the meal before the protein/fat-based component (scrambled egg) on their first study visit, will be asked to eat the meal in the reverse order at their second study visit.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 50 Years
- Who
- Female
- Number of participants
- 35
- Started
- 2025-12-11
- Last checked
- 2025-12
Plain English Summary
What is this study?
- • Testing a new treatment for gestational diabetes mellitus (gdm)
- • NA - 35 participants
- • The goal of this clinical trial is to determine whether the sequence of macronutrient consumption affects post-prandial glycaemia in women with gestational diabetes mellitus
Who can take part?
- • Ages 18 Years to 50 Years
- • Diagnosed with gestational diabetes mellitus (gdm)
- • Female only
Where?
- • Belfast - Centre for Public Health, Institute of Clinical Sciences A
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of this clinical trial is to determine whether the sequence of macronutrient consumption affects post-prandial glycaemia in women with gestational diabetes mellitus. The main questions it aims to answer are: * The difference in the magnitude of postprandial rise in blood glucose between the two test meals as measured by Flash Glucose Monitoring (FGM) sensor, alongside blood/serum glucose from collected intravenous blood samples and finger prick results. * The difference in the magnitude of postprandial change in serum levels of gut hormones between the two test meals. * The difference in mean change in pre-post ingestion satiety scores between the two test meals. * The difference in 24 hour energy and macronutrient intake following the two test meals. Participants will attend two study visits at the Centre for Public Health, with an interval of at least two days between the visits and complete the following, anthropometric measurements, demographic and appetite questionnaires, glucose measurements, two food diaries and fasting blood samples and the consumption of the study breakfast. Participants will be asked to eat either the protein/fat-based component of the meal (scrambled egg) before or after the carbohydrate-based component (wholemeal toast) on their first visit and on the other visit they will be asked to eat the meal in the reverse order. The order in which this occurs will be randomised and each participant will act as their own control. Researchers will compare the results from participants between the two test meals to see if the order of macronutrient consumption has any effect on post-prandial glycaemia, gut hormones, satiety scores and energy and macronutrient intake.
More detail
Gestational diabetes mellitus (GDM) is glucose intolerance with onset or first diagnosis during pregnancy, affecting around 1 in 10 pregnancies in the United Kingdom (UK). Women with GDM are 10 times more likely to develop type 2 DM and twice as likely to develop cardiovascular disease in later life than women without GDM. Dietary modification is recommended as first line management to optimise blood glucose control. However, this often fails, necessitating the use of medication such as metformin and insulin. There is a pressing need to find safe and effective dietary approaches to optimise glycaemic control in GDM which can be easily adhered to in order to improve longer-term outcomes. The impact of the sequence of macronutrients on glycaemic control is an emerging area of interest. Recent evidence suggests that the consumption of the fat/protein components of a meal prior to the carbohydrate components, reduces the peak by around 40% after food. This study aims to determine whether the order that macronutrients (i.e. protein, fat, carbohydrate) are eaten affects; blood sugar glucose levels in the blood after a meal, appetite, food intake and the release of hormones in the body, in women with GDM. Pregnant women with GDM, aged 18-50 years old who are between 24-37 weeks pregnant are eligible for the study. Women are not eligible if they have a history of type 1 or 2 diabetes, any clinically confirmed food allergies, taking medication for GDM at point of study entry, severe nausea, using anti-sickness medication or any other problems that would substantially limit ability to complete study requirements. Recruitment will be via antenatal clinics in the South-Eastern Health and Social Care Trust (SEHSCT) and also via social media. Participants will attend the Centre for Public Health on two occasions (maximum 2 weeks between visits) and will involve the collection of demographic information, weight and height measurements, blood samples, glucose measurements, consumption of study breakfast, and completion of two 1-day food diaries. Participants will be asked to eat either the protein/fat-based component of the meal (scrambled egg) before or after the carbohydrate-based component (wholemeal toast) on their first visit and on the other visit they will be asked to eat the meal in the reverse order. The order in which this occurs will be randomised and each participant will act as their own control. Scrambled egg was chosen as the protein and fat will be homogenously distributed (compared to boiled egg, for example). Wholemeal toast was chosen as, although lower glycaemic index and therefore less likely to expeditiously raise blood glucose than toasted white bread, it will be more consistent with the participants' existing dietary needs.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 50 Years
- Who can join: Female only
What the study is looking for
- ✓Pregnant women with gestational diabetes mellitus
- ✓Aged 18-50 years old
- ✓Between 24-37 weeks pregnant
Who cannot take part
- ✗History of type 1 or type 2 diabetes mellitus
- ✗Dietary restrictions or clinically confirmed food allergies that may affect study requirements
- ✗Pharmacologically managed GDM at the point of study entry
- ✗Hyperemesis gravidarum at the point of study entry (i.e. prolonged/severe nausea and vomiting)
- ✗Using antiemetic medication (e.g. dimenhydrinate, prochlorperazine, promethazine)
See the full criteria
Where Is This Study? (1 UK site)
Centre for Public Health, Institute of Clinical Sciences A
Belfast BT12 6BA, United Kingdom
How to Get in Touch
Hannah O'Hara, MBBS BSc PhD DFSRH MRCGP
Sponsor contactCONTACT
Danielle Logan, PhD
Sponsor contactCONTACT
