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NCT06804187Enrolling by invitation

Sweet Sensing in Type 2 Diabetes

Identifying the Mechanisms of Gut-brain Axis to Sweet Sensing in Patients With Type 2 Diabetes Using Neuroimaging Techniques

Source: ClinicalTrials.gov · Last updated 8 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
505 (estimated)
First submitted
27 Jan 2025
Start date
1 Feb 2025
Primary completion date
31 May 2026
Lead sponsor
University of Nottingham
NCT number
NCT06804187

What you commit to

  • Study type: Observational
  • Planned participants: 505
  • From 1 Feb 2025 to the primary completion date, 31 May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
    • Phase 2 and 3 exclusion criteria
  • those who have contraindications to MRI including metal implants
  • 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)

Other illness

  • individuals with Neurological or gastrointestinal disorders (IBD/ IBS)

Other

  • those who are unable to lie flat
  • smokers

Who the study is looking for

  • 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.

Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Nottingham
Coordinator of this site? Confirm its status
NottinghamUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.