Repositioning Omega-3 Fatty Acids For Treatment Of Glycaemia And Cardiometabolic Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the change in fasting glucose from baseline after 28 days of treatment, compared to each treatment group and placebo.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants receiving Semaglutide will be aware of treatment allocation due to the nature of administration, while participants receiving omega-3 supplementation or placebo will remain blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
干预措施: Placebo (Dietary Supplement)
Omega-3 Fatty Acid Supplementation (EPA/DHA)
干预措施: Omega-3 Fatty Acids (Dietary Supplement)
Omega-3 Fatty Acid Supplementation (ALA)
干预措施: Omega-3 Fatty Acids (Dietary Supplement)
Omega-3 Fatty Acid Supplementation (EPA/DHA) and Semaglutide
Semaglutide is being used for comparison purposes only
干预措施: Omega-3 Fatty Acids (Dietary Supplement)
Omega-3 Fatty Acid Supplementation (EPA/DHA) and Semaglutide
Semaglutide is being used for comparison purposes only
干预措施: Semaglutide 0.25 mg (Drug)
结局指标
主要结局
To evaluate the change in fasting glucose from baseline after 28 days of treatment, compared to each treatment group and placebo.
时间窗: From baseline to 28 days of treatment
次要结局
- The change in insulin compared to placebo administration(From baseline to 28 days of treatment)
- The change in HbA1c compared to placebo administration(From baseline to 28 days of treatment)
- Glucose tolerance measurements during OGTT compared to placebo administration(From baseline to 28 days of treatment)
- Area under the curve measurements during OGTT compared to placebo administration(From baseline to 28 days of treatment)
- Plasma gut hormone concentrations (GLP-1, GIP, PYY, ghrelin, CCK and glucagon) compared to placebo administration(From baseline to 28 days of treatment)
- Full lipid profile (cardiovascular risk markers) compared to placebo administration(From baseline to 28 days of treatment)
- Inflammatory and cardiovascular markers compared to placebo administration(From baseline to 28 days of treatment)
- Liver function tests (ALT and AST) compared to placebo administration(From baseline to 28 days of treatment)
- Body mass index (BMI) compared to placebo administration(From baseline to 28 days of treatment)
- Waist-to-hip circumference compared to placebo administration(From baseline to 28 days of treatment)
- Blood pressure compared to placebo administration(From baseline to 28 days of treatment)
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index compared to placebo administration(From baseline to 28 days of treatment)
- Change in Omega-3 Index (EPA and DHA as a percentage of total fatty acids) compared to placebo administration(From baseline to 28 days of treatment)