Free Fatty Acid Effects In Type 2 Diabetes

NCT07677995 | Enrolling By Invitation

• 2 other identifiers: 26/ES/0021TA/PPA/25/215037
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Cardiovascular Disease; Omega-3 Fatty Acids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Omega-3 Fatty Acid Supplementation (EPA/DHA)

EXPERIMENTAL

Dietary Supplement: Omega-3 Fatty Acids

Omega-3 Fatty Acid Supplementation (ALA)

EXPERIMENTAL

Dietary Supplement: Omega-3 Fatty Acids

Omega-3 Fatty Acid Supplementation (EPA/DHA) and Semaglutide

EXPERIMENTAL

Semaglutide is being used for comparison purposes only

Dietary Supplement: Omega-3 Fatty Acids; Drug: Semaglutide 0.25 mg

Interventions

Omega-3 Fatty Acids DIETARY_SUPPLEMENT

1500mg/day for 28 days

Omega-3 Fatty Acid Supplementation (ALA); Omega-3 Fatty Acid Supplementation (EPA/DHA); Omega-3 Fatty Acid Supplementation (EPA/DHA) and Semaglutide

Semaglutide 0.25 mg DRUG

0.25mg weekly for four weeks

Omega-3 Fatty Acid Supplementation (EPA/DHA) and Semaglutide

Placebo DIETARY_SUPPLEMENT

Receive placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ulster: lead

Study Sites (1)

School of Biomedical Sciences

Coleraine, County Londonderry, BT52 1SA, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Interventions

Fatty Acids, Omega-3; semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

GB (1)