Gestational Diabetes Mellitus (GDM)DEFI-GDMNCT06896799
Determining the Effect of Food Ordering on Blood Glucose In Gestational Diabetes Mellitus (DEFI-GDM)
A study testing Visit 1: Protein/fat then carbohydrate. Visit 2: Carbohydrate then protein/fat. and Visit 1: Carbohydrate then protein/fat. Visit 2: Protein/fat then carbohydrate. in people with Gestational Diabetes Mellitus (GDM), run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Visit 1: Protein/fat then carbohydrate. Visit 2: Carbohydrate then protein/fat. and Visit 1: Carbohydrate then protein/fat. Visit 2: Protein/fat then carbohydrate.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Dec 2025to 1 Feb 2027
- Phase
- Interventional
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women with gestational diabetes mellitus
- Aged 18-50 years old
- Between 24-37 weeks pregnant
Who cannot join
- 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)
- Any other problems or medical conditions that would substantially limit their ability to complete the study requirements
- Participants can be recruited onto the study if they have previously had GDM in another pregnancy. Participants can also be recruited if they are involved in other research studies, but this will depend on the study type and the decision will be made by the Chief/Principal Investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Centre for Public Health, Institute of Clinical Sciences A
Belfast, BT12 6BA
Hannah O'Hara, MBBS BSc PhD DFSRH MRCGP, +44 (0) 28 9097 6350, h.ohara@qub.ac.uk
Danielle Logan, PhD, +44 (0) 28 9097 6350, d.logan@qub.ac.uk
About this study
Official title: Determining the Effect of Food Ordering on Blood Glucose In Gestational Diabetes Mellitus (DEFI-GDM) - a Randomised Crossover Study
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Being tested
- Visit 1: Protein/fat then carbohydrate. Visit 2: Carbohydrate then protein/fat., Visit 1: Carbohydrate then protein/fat. Visit 2: Protein/fat then carbohydrate.
- Keywords
- Gestational Diabetes Mellitus, Post-prandial glycaemia, Food Ordering
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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. Meals will be prepared by members of the research team who have completed Food Safety training. Participants will be asked to consume a 440kcal breakfast meal within 10 minutes, approximately 1.5 hours after arrival at their first study visit and approximately 30 minutes after arrival 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. Meals will be prepared by members of the research team who have completed Food Safety training. Participants will be asked to consume a 440kcal breakfast meal within 10 minutes, approximately 1.5 hours after arrival at their first study visit and approximately 30 minutes after arrival at their second study visit.
| Study group | Role | What they receive |
|---|---|---|
| Visit 1: Protein/fat then carbohydrate. Visit 2: Carbohydrate then protein/fat. | Experimental | 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 and on their second study 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. Receives: Other: Visit 1: Protein/fat then carbohydrate. Visit 2: Carbohydrate then protein/fat. |
| Visit 1: Carbohydrate then protein/fat. Visit 2: Protein/fat then carbohydrate." | Experimental | 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 and on their second study 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. Receives: Other: Visit 1: Carbohydrate then protein/fat. Visit 2: Protein/fat then carbohydrate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Glucose
The difference in the magnitude of postprandial rise in blood glucose between the two test meals.
We will look at interstitial glucose from the FGM sensor alongside blood/serum glucose from collected intravenous blood samples and finger prick results.
Measured: Difference between Visit 1 [time 0 and 125 minutes] and Visit 2 [time 0 and 125 minutes]
Secondary outcomes (8)
Insulin
The difference in the magnitude of postprandial change in serum levels of insulin between the two test meals.
Measured: Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes]
C-Peptide
The difference in the magnitude of postprandial change in serum levels of c-peptide between the two test meals.
Measured: Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes]
Total Ghrelin
The difference in the magnitude of postprandial change in serum levels of total ghrelin between the two test meals.
Measured: Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes]
Glucagon (GCG)
The difference in the magnitude of postprandial change in serum levels of GCG between the two test meals.
Measured: Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes]
Glucagon-like peptide-1 (GLP-1)
The difference in the magnitude of postprandial change in serum levels of GLP-1 between the two test meals.
Measured: Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes]
Peptide Tyrosine (PYY)
The difference in the magnitude of postprandial change in serum levels of PYY between the two test meals.
Measured: Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes]
Satiety Scores
The difference in mean change in pre-post ingestion satiety scores between the two test meals, using an appetite visual analogue scale (range 0 - 100) [The direction of the score will depend on the individual question].
Measured: Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes]
Nutrient intake
The difference in 24 hour energy and macronutrient intake following the two test meals.
Measured: Difference between Visit 1 [time 0 and 24 hours] and Visit 2 [time 0 and 24 hours]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start11 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This will be a randomised crossover study. 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.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Principal investigator, Hannah O'Hara, Queen's University, Belfast
- Investigators
- Hannah O'Hara, MBBS BSc PhD DFSRH MRCGP, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896799
- Sponsor's protocol ID
- 25/NI/0004
- Acronym
- DEFI-GDM
- Status last verified
- Dec 2025
- First submitted
- 4 Mar 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The researchers are happy to share results from the study for the purposes of a meta-analysis. This will be completed on approach to the researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Food Ordering on Blood Glucose In Gestational Diabetes Mellitus (DEFI-GDM) - a Randomised Crossover Study
- ClinicalTrials.gov ID
- NCT06896799
- Acronym / sponsor ID
- DEFI-GDM / 25/NI/0004
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- Gestational Diabetes Mellitus, Post-prandial glycaemia, Food Ordering
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 26 Mar 2025 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a randomised crossover study. 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.
| Arm | Type | Receives |
|---|---|---|
| Visit 1: Protein/fat then carbohydrate. Visit 2: Carbohydrate then protein/fat. | Experimental | Other: Visit 1: Protein/fat then carbohydrate. Visit 2: Carbohydrate then protein/fat.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 and on their second study 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. |
| Visit 1: Carbohydrate then protein/fat. Visit 2: Protein/fat then carbohydrate." | Experimental | Other: Visit 1: Carbohydrate then protein/fat. Visit 2: Protein/fat then carbohydrate.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 and on their second study 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women with gestational diabetes mellitus
- Aged 18-50 years old
- Between 24-37 weeks pregnant
Key exclusion criteria (7 listed)
- 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)
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 |
|---|---|---|
| Visit 1: Protein/fat then carbohydrate. Visit 2: Carbohydrate then protein/fat.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. Meals will be prepared by members of the research team who have completed Food Safety training. Participants will be asked to consume a 440kcal breakfast meal within 10 minutes, approximately 1.5 hours after arrival at their first study visit and approximately 30 minutes after arrival at their second study visit. | Other | Visit 1: Protein/fat then carbohydrate. Visit 2: Carbohydrate then protein/fat. |
| Visit 1: Carbohydrate then protein/fat. Visit 2: Protein/fat then carbohydrate.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. Meals will be prepared by members of the research team who have completed Food Safety training. Participants will be asked to consume a 440kcal breakfast meal within 10 minutes, approximately 1.5 hours after arrival at their first study visit and approximately 30 minutes after arrival at their second study visit. | Other | Visit 1: Carbohydrate then protein/fat. Visit 2: Protein/fat then carbohydrate." |
Primary outcome
Postprandial Glucose
Time frame: Difference between Visit 1 [time 0 and 125 minutes] and Visit 2 [time 0 and 125 minutes]
The difference in the magnitude of postprandial rise in blood glucose between the two test meals. We will look at interstitial glucose from the FGM sensor alongside blood/serum glucose from collected intravenous blood samples and finger prick results.
8 secondary outcomes
Insulin
Time frame: Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes]
C-Peptide
Time frame: Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes]
Total Ghrelin
Time frame: Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes]
Glucagon (GCG)
Time frame: Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes]
Glucagon-like peptide-1 (GLP-1)
Time frame: Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes]
Peptide Tyrosine (PYY)
Time frame: Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes]
Satiety Scores
Time frame: Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes]
Nutrient intake
Time frame: Difference between Visit 1 [time 0 and 24 hours] and Visit 2 [time 0 and 24 hours]
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 12 Aug 2026.
- Individual participant dataSharing planned: Yes. The researchers are happy to share results from the study for the purposes of a meta-analysis. This will be completed on approach to the researchers.
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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.
Hannah O'Hara, MBBS BSc PhD DFSRH MRCGP principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visit 1: Protein/fat then carbohydrate. Visit 2: Carbohydrate then protein/fat. and Visit 1: Carbohydrate then protein/fat. Visit 2: Protein/fat then carbohydrate. in people with Gestational Diabetes Mellitus (GDM), run by Queen's University, Belfast 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 12 Aug 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?
Contact Hannah O'Hara, MBBS BSc PhD DFSRH MRCGP (+44 (0) 28 9097 6350, h.ohara@qub.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial Glucose (time frame: Difference between Visit 1 [time 0 and 125 minutes] and Visit 2 [time 0 and 125 minutes]). 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 12 Aug 2026.