Sweet Sensing in Type 2 Diabetes

NCT06804187 | Enrolling By Invitation

• 1 other identifier: 24008
• Study Type: observational
• Target: 505
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

  Feb 2025 to Dec 2026

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, East Midlands, NG7 2QE, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples will be taken and will check for glucose, HbA1c, c-peptide, insulin, 3-OMG and GLP-1

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Officials

• Sally Eldeghaidy, BSc, MSc, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 3, 2025
• Study Start: February 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)