Cardiovascular Disease, Omega-3 Fatty Acids, Type 2 Diabetes
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTOmega-3 Fatty Acids
1500mg/day for 28 days
0.25mg weekly for four weeks
DIETARY_SUPPLEMENTPlacebo
Receive placebo
Sponsors
University of Ulster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the change in fasting glucose from baseline after 28 days of treatment, compared to each treatment group and placebo. | From baseline to 28 days of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Biomarkers include inflammatory markers (C-reactive protein \[CRP\], pro- and anti-inflammatory cytokines) and cardiovascular risk markers |
| 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 | Weight (kg) and height (m) will be combined to report BMI in kg/m\^2 |
| Waist-to-hip circumference compared to placebo administration | From baseline to 28 days of treatment | 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 |
| 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 | 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. |
| 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 | — |
Countries
United Kingdom
Outcome results
None listed