Type 2 DiabetesNCT06804187
Sweet Sensing in Type 2 Diabetes
An observational study of Type 2 Diabetes and Prediabetes, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Diabetes is a global challenge and the number of people affected by diabetes is expected to rise to 5.5 million by 2030, of which 90% are type 2 diabetes (T2D). Habitual high consumption of sugars is an important risk factor in the development, and progression, of type 2 diabetes (T2D). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Prediabetes
- How many people
- 505 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2025to Jun 2026
- How long will I take part?
- 1 Day
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: We will be inviting potential participants from primary care team and also healthy volunteer from the university campus or to the public by displaying poster around the campus and health facilities.
Who may be able to join
- General Eligibility Criteria
- For T2D: Confirmed Type 2 Diabetes Mellitus (HbA1c>48 mmol/mol (6.5%) and managed by the anti-diabetic drug metformin alone diagnosed within the last 10 years
- For Prediabetes: HbA1c 42-48 mmol/mol and no less than 3 years since diagnosis
- Non-diabetes who had HbA1c screened at their GP in the last 12 months: HbA1c≤42mmol/mol
- Phase 1
- Adults aged between 18 -60 years with type 2 diabetes or healthy individuals who had HbA1c checked within the last 12 months. Healthy volunteers who did not have HbA1c screened at their GP will be offered an opportunistic screening blood test.
- Phase 2 and 3:
- right-handed adults between 18- 60 years with type 2 diabetes, pre-diabetes and healthy individuals who had HbA1c checked within the last 12 months. Healthy volunteers who did not have HbA1c screened at their GP will be offered an opportunistic screening blood test.
Who cannot join
- Phase 1 exclusion criteria
- Current pregnancy or breastfeeding
- Current treatment with insulin or any other diabetic medications apart from metformin
- History of neurological, gastrointestinal injury or disease
- Any medication that is known to alter taste perception
- Smokers
Show all 12Show fewer
- Phase 2 and 3 exclusion criteria
- individuals with Neurological or gastrointestinal disorders (IBD/ IBS)
- those who have contraindications to MRI including metal implants
- those who are unable to lie flat
- smokers
- those who have taken part in research projects within the last 3 months (projects involving administering a drug, invasive procedure i.e. venepuncture >50 ml, endoscopy, or exposure to ionising radiation)
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
University of Nottingham
Nottingham, East Midlands, NG7 2QE
About this study
Official title: Identifying the Mechanisms of Gut-brain Axis to Sweet Sensing in Patients With Type 2 Diabetes Using Neuroimaging Techniques
Diabetes is a global challenge and the number of people affected by diabetes is expected to rise to 5.5 million by 2030, of which 90% are type 2 diabetes (T2D). Habitual high consumption of sugars is an important risk factor in the development, and progression, of type 2 diabetes (T2D). Several studies have now shown that individuals with T2D have reduced lingual sweet taste sensation and this in turns increases their sugar intake to achieve the same hedonic reward values compared to the healthy population. This subsequently will lead to development of diabetes or worsening of the blood sugar control.
Phase 1 of our study aims to identify the alterations in oral sweet taste sensitivity in individuals with type 2 diabetes and assess whether this is linked to sweet preference and habitual sugar consumption. In phase 2, we will use functional magnetic resonance imaging (MRI), a powerful technique used widely for diagnosing disease and investigating physiological and pathological process, to investigate whether diabetes or prediabetes status modulates activation of taste and reward-related brain responses to lingual sweet taste stimulation. Phase 3 will be investigating the reward-related brain responses to gut taste stimulation using functional MRI.
These new data will reveal the central mechanisms of sweet sensing in different status of diabetes and this will help develop novel treatment targets to improve metabolic and vascular outcomes in individuals with prediabetes or T2D.
- Conditions
- Type 2 Diabetes, Prediabetes
- Keywords
- sweet sensitivity, Type 2 diabetes, pre diabetes, sweet preference, sugar craving, taste receptors
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes group | Inclusion criteria right or left handed age between 18-60 years HbA1c >48 mmol/mol duration of diabetes less than 10 years only for those who are treated with metformin excluding those with neurological disorder, gastrointestinal disorders, current pregnancy or breast feeding, on medications which can alter taste perception, current smokers, allergy to sugar, those who has contraindication to MRI, those who cannot lie flat, those who have taken part in research projects within the last 3 months | |
| Prediabetes group | Inclusion criteria right handed individuals age between 18-60 years HbA1c between 42-48 mmol/mol, diagnosis of pre-diabetes not less than 3 years only for those who are treated with metformin excluding those with neurological disorder, gastrointestinal disorders, current pregnancy or breast feeding, on medications which can alter taste perception, current smokers, allergy to sugar, those who has contraindication to MRI, those who cannot lie flat, those who have taken part in research projects within the last 3 months | |
| Healthy group | Inclusion criteria right or left handed individuals age between 18-60 years HbA1c </=42 mmol/mol only for those who are treated with metformin excluding those with neurological disorder, gastrointestinal disorders, current pregnancy or breast feeding, on medications which can alter taste perception, current smokers, allergy to sugar, those who has contraindication to MRI, those who cannot lie flat, those who have taken part in research projects within the last 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the sensitivity and preference of lingual sweet taste in individuals with T2D, and those without T2D to evaluate how this is impacted by habitual sugar consumption.
Measured: December 2024 to December 2026
To compare brain responses to lingual sweet sensing in individuals with prediabetes and T2D, and those without prediabetes or T2D, and their association with habitual sugar consumption.
Measured: from Dec 2024 to Dec 2026
Secondary outcomes (1)
To determine how brain responses to intestinal sweet sening predict the rate of intestinal glucose absorption.
Measured: Feb 2025 to Dec 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Feb 2025
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 505 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sally Eldeghaidy, BSc, MSc, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804187
- Sponsor's protocol ID
- 24008
- Status last verified
- Dec 2024
- First submitted
- 27 Jan 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not planning to share individual participant data but will publish in scientific papers and conferences with the overall results.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Mechanisms of Gut-brain Axis to Sweet Sensing in Patients With Type 2 Diabetes Using Neuroimaging Techniques
- ClinicalTrials.gov ID
- NCT06804187
- Acronym / sponsor ID
- 24008
- Conditions
- Type 2 Diabetes, Prediabetes
- Keywords
- sweet sensitivity, Type 2 diabetes, pre diabetes, sweet preference, sugar craving, taste receptors
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 505 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 3 Feb 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.
Diabetes is a global challenge and the number of people affected by diabetes is expected to rise to 5.5 million by 2030, of which 90% are type 2 diabetes (T2D). Habitual high consumption of sugars is an important risk factor in the development, and progression, of type 2 diabetes (T2D). Several studies have now shown that individuals with T2D have reduced lingual sweet taste sensation and this in turns increases their sugar intake to achieve the same hedonic reward values compared to the healthy population. This subsequently will lead to development of diabetes or worsening of the blood sugar control.
Phase 1 of our study aims to identify the alterations in oral sweet taste sensitivity in individuals with type 2 diabetes and assess whether this is linked to sweet preference and habitual sugar consumption. In phase 2, we will use functional magnetic resonance imaging (MRI), a powerful technique used widely for diagnosing disease and investigating physiological and pathological process, to investigate whether diabetes or prediabetes status modulates activation of taste and reward-related brain responses to lingual sweet taste stimulation. Phase 3 will be investigating the reward-related brain responses to gut taste stimulation using functional MRI.
These new data will reveal the central mechanisms of sweet sensing in different status of diabetes and this will help develop novel treatment targets to improve metabolic and vascular outcomes in individuals with prediabetes or T2D.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes group | – | –Inclusion criteria right or left handed age between 18-60 years HbA1c >48 mmol/mol duration of diabetes less than 10 years only for those who are treated with metformin excluding those with neurological disorder, gastrointestinal disorders, current pregnancy or breast feeding, on medications which can alter taste perception, current smokers, allergy to sugar, those who has contraindication to MRI, those who cannot lie flat, those who have taken part in research projects within the last 3 months |
| Prediabetes group | – | –Inclusion criteria right handed individuals age between 18-60 years HbA1c between 42-48 mmol/mol, diagnosis of pre-diabetes not less than 3 years only for those who are treated with metformin excluding those with neurological disorder, gastrointestinal disorders, current pregnancy or breast feeding, on medications which can alter taste perception, current smokers, allergy to sugar, those who has contraindication to MRI, those who cannot lie flat, those who have taken part in research projects within the last 3 months |
| Healthy group | – | –Inclusion criteria right or left handed individuals age between 18-60 years HbA1c </=42 mmol/mol only for those who are treated with metformin excluding those with neurological disorder, gastrointestinal disorders, current pregnancy or breast feeding, on medications which can alter taste perception, current smokers, allergy to sugar, those who has contraindication to MRI, those who cannot lie flat, those who have taken part in research projects within the last 3 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We will be inviting potential participants from primary care team and also healthy volunteer from the university campus or to the public by displaying poster around the campus and health facilities.
Key inclusion criteria (8 listed)
- General Eligibility Criteria
- Phase 1
- Adults aged between 18 -60 years with type 2 diabetes or healthy individuals who had HbA1c checked within the last 12 months. Healthy volunteers who did not have HbA1c screened at their GP will be offered an opportunistic screening blood test.
- right-handed adults between 18- 60 years with type 2 diabetes, pre-diabetes and healthy individuals who had HbA1c checked within the last 12 months. Healthy volunteers who did not have HbA1c screened at their GP will be offered an opportunistic screening blood test.
Key exclusion criteria (12 listed)
- Phase 1 exclusion criteria
- Phase 2 and 3 exclusion criteria
- individuals with Neurological or gastrointestinal disorders (IBD/ IBS)
- those who have contraindications to MRI including metal implants
- those who are unable to lie flat
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the sensitivity and preference of lingual sweet taste in individuals with T2D, and those without T2D to evaluate how this is impacted by habitual sugar consumption.
Time frame: December 2024 to December 2026
To compare brain responses to lingual sweet sensing in individuals with prediabetes and T2D, and those without prediabetes or T2D, and their association with habitual sugar consumption.
Time frame: from Dec 2024 to Dec 2026
1 secondary outcome
To determine how brain responses to intestinal sweet sening predict the rate of intestinal glucose absorption.
Time frame: Feb 2025 to Dec 2026
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 8 Jul 2025.
- Individual participant dataSharing planned: No. We are not planning to share individual participant data but will publish in scientific papers and conferences with the overall results.
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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.
Sally Eldeghaidy, BSc, MSc, PhD principal investigator
University of Nottingham
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 Type 2 Diabetes and Prediabetes, run by University of Nottingham 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 8 inclusion and 12 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: enrolling by invitation, as of the sponsor's last update on 8 Jul 2025. 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?
To assess the sensitivity and preference of lingual sweet taste in individuals with T2D, and those without T2D to evaluate how this is impacted by habitual sugar consumption. (time frame: December 2024 to December 2026). The study lists 2 primary outcomes in all. 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 8 Jul 2025.