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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
1500mg/day for 28 days
0.25mg weekly for four weeks
Receive placebo
School of Biomedical Sciences
Coleraine, County Londonderry, United Kingdom
To evaluate the change in fasting glucose from baseline after 28 days of treatment, compared to each treatment group and placebo.
Time frame: From baseline to 28 days of treatment
The change in insulin compared to placebo administration
Time frame: From baseline to 28 days of treatment
The change in HbA1c compared to placebo administration
Time frame: From baseline to 28 days of treatment
Glucose tolerance measurements during OGTT compared to placebo administration
Time frame: From baseline to 28 days of treatment
Area under the curve measurements during OGTT compared to placebo administration
Time frame: From baseline to 28 days of treatment
Plasma gut hormone concentrations (GLP-1, GIP, PYY, ghrelin, CCK and glucagon) compared to placebo administration
Time frame: From baseline to 28 days of treatment
Full lipid profile (cardiovascular risk markers) compared to placebo administration
Time frame: From baseline to 28 days of treatment
Inflammatory and cardiovascular markers compared to placebo administration
Biomarkers include inflammatory markers (C-reactive protein \[CRP\], pro- and anti-inflammatory cytokines) and cardiovascular risk markers
Time frame: From baseline to 28 days of treatment
Liver function tests (ALT and AST) compared to placebo administration
Time frame: From baseline to 28 days of treatment
Body mass index (BMI) compared to placebo administration
Weight (kg) and height (m) will be combined to report BMI in kg/m\^2
Time frame: From baseline to 28 days of treatment
Waist-to-hip circumference compared to placebo administration
Waist circumference (in cm between the lower rib and iliac crest) and hip circumference (in cm at the widest part of the hips/buttocks) will be combined to calculate waist-to-hip circumference
Time frame: From baseline to 28 days of treatment
Blood pressure compared to placebo administration
Time frame: From baseline to 28 days of treatment
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index compared to placebo administration
Insulin resistance will be measured by calculating HOMA-IR using the formula: HOMA-IR = fasting plasma glucose (mg/dL) x fasting plasma insulin/405. Higher values indicate greater insulin resistance. This is a derived continuous index with no fixed minimum or maximum value.
Time frame: 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
Time frame: From baseline to 28 days of treatment
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