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Набор по приглашению NCT07677995

Free Fatty Acid Effects In Type 2 Diabetes

Без фазы С лечением Type 2 Diabetes Cardiovascular Disease Omega-3 Fatty Acids

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
В протоколе указаны: Omega-3 Fatty Acids, Semaglutide 0.25 mg, Placebo.
Кому может быть актуально
Состояния в реестре: Type 2 Diabetes, Cardiovascular Disease, Omega-3 Fatty Acids. Базовые параметры: от 18 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

Repositioning Omega-3 Fatty Acids For Treatment Of Glycaemia And Cardiometabolic Disease

Обзор

Omega-3 fatty acids are natural fats found in foods such as oily fish and flaxseed. Omega-3 fatty acids have been found to have positive effects on cardiovascular health, but there is less evidence on if they can help manage blood glucose in individuals with both cardiovascular disease and type 2 diabetes. This study will investigate whether the beneficial effects found in omega-3 fatty acids such as lowered blood glucose and reduced inflammation - both of which are important for managing type 2 diabetes and cardiovascular disease, can be beneficial for individuals with type 2 diabetes. As omega-3 fatty acids are already found naturally in food, and are already available as supplements, they could be a safe option to help manage these diseases. The aim of this study is to investigate if omega-3 fatty acids can slow down the progression of type 2 diabetes and reduce the risk of cardiovascular disease in individuals with type 2 diabetes.

Вмешательства

  • Пищевая добавка Omega-3 Fatty Acids
    1500mg/day for 28 days
  • Препарат Semaglutide 0.25 mg
    0.25mg weekly for four weeks
  • Пищевая добавка Placebo
    Receive placebo

Первичные конечные точки

  • To evaluate the change in fasting glucose from baseline after 28 days of treatment, compared to each treatment group and placebo. [Срок оценки: From baseline to 28 days of treatment]
Вторичные конечные точки (12)
  • The change in insulin compared to placebo administration [Срок оценки: From baseline to 28 days of treatment]
  • The change in HbA1c compared to placebo administration [Срок оценки: From baseline to 28 days of treatment]
  • Glucose tolerance measurements during OGTT compared to placebo administration [Срок оценки: From baseline to 28 days of treatment]
  • Area under the curve measurements during OGTT compared to placebo administration [Срок оценки: From baseline to 28 days of treatment]
  • Plasma gut hormone concentrations (GLP-1, GIP, PYY, ghrelin, CCK and glucagon) compared to placebo administration [Срок оценки: From baseline to 28 days of treatment]
  • Full lipid profile (cardiovascular risk markers) compared to placebo administration [Срок оценки: From baseline to 28 days of treatment]
  • Inflammatory and cardiovascular markers compared to placebo administration [Срок оценки: From baseline to 28 days of treatment]
  • Liver function tests (ALT and AST) compared to placebo administration [Срок оценки: From baseline to 28 days of treatment]
  • Body mass index (BMI) compared to placebo administration [Срок оценки: From baseline to 28 days of treatment]
  • Waist-to-hip circumference compared to placebo administration [Срок оценки: From baseline to 28 days of treatment]
  • Blood pressure compared to placebo administration [Срок оценки: From baseline to 28 days of treatment]
  • Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index compared to placebo administration [Срок оценки: From baseline to 28 days of treatment]

Критерии участия

Критерии включения

  • Individuals who are over 18 years of age with a BMI between 25-50 kg/m2, and who have been diagnosed with T2DM (>7.0 mmol/l fasting glucose) or pre-diabetes (impaired glucose tolerant 5.0-6.9mmol/l) and are either on no medication, are diet controlled or taking metformin. Participants may also have a history of cardiovascular disease.

Критерии исключения

  • Those who have severe or unstable cardiovascular disease
  • Type 2 diabetics or prediabetics who are on an anti-diabetic medication (with the exception of metformin)
  • Undergone recent major surgery or planned surgery during the study period
  • Have implanted devices (such as pacemakers or defibrillators)
  • Have an active infection
  • Are involved in any other type of weight loss study/intervention
  • Are pregnant/breastfeeding.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Великобритания · 1 центр
  • School of Biomedical Sciences — Coleraine

Идентификаторы

NCT: NCT07677995 · 26/ES/0021 · TA/PPA/25/215037

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗