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Enrolling by Invitation

NCT Number: NCT07677995

Free Fatty Acid Effects In Type 2 Diabetes

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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Key information

Conditions

Type 2 Diabetes Cardiovascular Disease Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Omega-3 Fatty Acids

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Biomedical Sciences

Coleraine, County Londonderry, BT52 1SA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega-3 fatty acids

Dietary Supplement

1500mg/day for 28 days

Semaglutide 0.25 mg

Drug

0.25mg weekly for four weeks

Placebo

Dietary Supplement

Receive placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. The change in insulin compared to placebo administration

    Time frame: From baseline to 28 days of treatment

  2. The change in HbA1c compared to placebo administration

    Time frame: From baseline to 28 days of treatment

  3. Glucose tolerance measurements during OGTT compared to placebo administration

    Time frame: From baseline to 28 days of treatment

  4. Area under the curve measurements during OGTT compared to placebo administration

    Time frame: From baseline to 28 days of treatment

  5. 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

  6. Full lipid profile (cardiovascular risk markers) compared to placebo administration

    Time frame: From baseline to 28 days of treatment

  7. Inflammatory and cardiovascular markers compared to placebo administration

    Time frame: From baseline to 28 days of treatment

    Biomarkers include inflammatory markers (C-reactive protein [CRP], pro- and anti-inflammatory cytokines) and cardiovascular risk markers

  8. Liver function tests (ALT and AST) compared to placebo administration

    Time frame: From baseline to 28 days of treatment

  9. Body mass index (BMI) compared to placebo administration

    Time frame: From baseline to 28 days of treatment

    Weight (kg) and height (m) will be combined to report BMI in kg/m^2

  10. Waist-to-hip circumference compared to placebo administration

    Time frame: 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

  11. Blood pressure compared to placebo administration

    Time frame: From baseline to 28 days of treatment

  12. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index compared to placebo administration

    Time frame: 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.

  13. 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

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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