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| ID | Type | Description | Link |
|---|---|---|---|
| TA/PPA/25/215037 | Other Grant/Funding Number | British Heart Foundation |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Omega-3 Fatty Acid Supplementation (EPA/DHA) | Experimental |
| |
| Omega-3 Fatty Acid Supplementation (ALA) | Experimental |
| |
| Omega-3 Fatty Acid Supplementation (EPA/DHA) and Semaglutide | Experimental | Semaglutide is being used for comparison purposes only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 Fatty Acids | Dietary Supplement | 1500mg/day for 28 days |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Biomedical Sciences | Coleraine | County Londonderry | BT52 1SA | United Kingdom |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| C000591245 | semaglutide |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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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.
| Semaglutide 0.25 mg | Drug | 0.25mg weekly for four weeks |
|
| Placebo | Dietary Supplement | Receive placebo |
|
| 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 | Biomarkers include inflammatory markers (C-reactive protein [CRP], pro- and anti-inflammatory cytokines) and cardiovascular risk markers | 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 | Weight (kg) and height (m) will be combined to report BMI in kg/m^2 | 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 | 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 | 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. | 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 |
| D004700 | Endocrine System Diseases |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |