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Набор по приглашению NCT06804187

Sweet Sensing in Type 2 Diabetes

— Наблюдательное Type 2 Diabetes Prediabetes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Type 2 Diabetes, Prediabetes. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
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Официальное название

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

Обзор

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.

Первичные конечные точки

  • 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. [Срок оценки: 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. [Срок оценки: from Dec 2024 to Dec 2026]
Вторичные конечные точки (1)
  • To determine how brain responses to intestinal sweet sening predict the rate of intestinal glucose absorption. [Срок оценки: Feb 2025 to Dec 2026]

Критерии участия

Критерии включения

  • 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

Критерии включения

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:

Критерии включения

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.

Критерии исключения

  • 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

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Великобритания · 1 центр
  • University of Nottingham — Nottingham

Идентификаторы

NCT: NCT06804187 · 24008

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗