Type 2 DiabetesNCT07677995
Free Fatty Acid Effects In Type 2 Diabetes
A study testing Omega-3 Fatty Acids and Semaglutide 0.25 mg in people with Type 2 Diabetes and Cardiovascular Disease, run by University of Ulster at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Cardiovascular Disease, Omega-3 Fatty Acids
- What is being tested?
- Omega-3 Fatty Acids and Semaglutide 0.25 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
School of Biomedical Sciences
Coleraine, County Londonderry, BT52 1SA
About this study
Official title: Repositioning Omega-3 Fatty Acids For Treatment Of Glycaemia And Cardiometabolic Disease
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
- Being tested
- Omega-3 Fatty Acids, Semaglutide 0.25 mg, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty AcidsDietary supplement
1500mg/day for 28 days
Semaglutide 0.25 mgDrug
0.25mg weekly for four weeks
PlaceboDietary supplement
Receive placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Omega-3 Fatty Acid Supplementation (EPA/DHA) | Experimental | Not described Receives: Dietary Supplement: Omega-3 Fatty Acids |
| Omega-3 Fatty Acid Supplementation (ALA) | Experimental | Not described Receives: Dietary Supplement: Omega-3 Fatty Acids |
| Omega-3 Fatty Acid Supplementation (EPA/DHA) and Semaglutide | Experimental | Semaglutide is being used for comparison purposes only Receives: Dietary Supplement: Omega-3 Fatty Acids; Drug: Semaglutide 0.25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the change in fasting glucose from baseline after 28 days of treatment, compared to each treatment group and placebo.
Measured: From baseline to 28 days of treatment
Secondary outcomes (13)
The change in insulin compared to placebo administration
Measured: From baseline to 28 days of treatment
The change in HbA1c compared to placebo administration
Measured: From baseline to 28 days of treatment
Glucose tolerance measurements during OGTT compared to placebo administration
Measured: From baseline to 28 days of treatment
Area under the curve measurements during OGTT compared to placebo administration
Measured: From baseline to 28 days of treatment
Plasma gut hormone concentrations (GLP-1, GIP, PYY, ghrelin, CCK and glucagon) compared to placebo administration
Measured: From baseline to 28 days of treatment
Full lipid profile (cardiovascular risk markers) compared to placebo administration
Measured: 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
Measured: From baseline to 28 days of treatment
Liver function tests (ALT and AST) compared to placebo administration
Measured: 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
Measured: 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
Measured: From baseline to 28 days of treatment
Blood pressure compared to placebo administration
Measured: 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.
Measured: 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
Measured: From baseline to 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677995
- Sponsor's protocol ID
- 26/ES/0021
- Other IDs
- TA/PPA/25/215037
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repositioning Omega-3 Fatty Acids For Treatment Of Glycaemia And Cardiometabolic Disease
- ClinicalTrials.gov ID
- NCT07677995
- Acronym / sponsor ID
- 26/ES/0021
- Conditions
- Type 2 Diabetes, Cardiovascular Disease, Omega-3 Fatty Acids
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 mgSemaglutide is being used for comparison purposes only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 Fatty Acids1500mg/day for 28 days | Dietary supplement | 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 mg0.25mg weekly for four weeks | Drug | Omega-3 Fatty Acid Supplementation (EPA/DHA) and Semaglutide |
| PlaceboReceive placebo | Dietary supplement | Placebo |
Primary outcome
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
13 secondary outcomes
The change in insulin compared to placebo administration
Time frame: From baseline to 28 days of treatment
The change in HbA1c compared to placebo administration
Time frame: From baseline to 28 days of treatment
Glucose tolerance measurements during OGTT compared to placebo administration
Time frame: From baseline to 28 days of treatment
Area under the curve measurements during OGTT compared to placebo administration
Time frame: From baseline to 28 days of treatment
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
Full lipid profile (cardiovascular risk markers) compared to placebo administration
Time frame: From baseline to 28 days of treatment
Inflammatory and cardiovascular markers compared to placebo administration
Time frame: From baseline to 28 days of treatment
Liver function tests (ALT and AST) compared to placebo administration
Time frame: From baseline to 28 days of treatment
Body mass index (BMI) compared to placebo administration
Time frame: From baseline to 28 days of treatment
Waist-to-hip circumference compared to placebo administration
Time frame: From baseline to 28 days of treatment
Blood pressure compared to placebo administration
Time frame: From baseline to 28 days of treatment
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index compared to placebo administration
Time frame: 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
Time frame: From baseline to 28 days of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Fatty Acids and Semaglutide 0.25 mg in people with Type 2 Diabetes and Cardiovascular Disease, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.