Free Fatty Acid Effects In Type 2 Diabetes

NCT07677995 — Not applicable, Enrolling by invitation, 60 participants, University of Ulster

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

Registry	NCT07677995
Status	Enrolling by invitation
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	60 (Estimated)
Sponsor	University of Ulster (Other)
Conditions	Type 2 Diabetes, Cardiovascular Disease, Omega-3 Fatty Acids
Interventions	Omega-3 Fatty Acids, Semaglutide 0.25 mg, Placebo (Dietary supplement, drug)
Dates	start 2026-09-01 (estimated), primary completion 2026-12-01 (estimated), completion 2027-02-01 (estimated), first posted 2026-07-01, last updated 2026-09-01
Locations	1 site in United Kingdom

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
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	Dietary Supplement: Omega-3 Fatty Acids; Drug: Semaglutide 0.25 mg	Semaglutide is being used for comparison purposes only

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

+Outcome measures

Primary outcomes

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

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]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
School of Biomedical Sciences	Coleraine, County Londonderry	United Kingdom

My Notes

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