Free Fatty Acid Effects In Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Omega-3 Fatty Acids, Semaglutide 0.25 mg, Placebo.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes, Cardiovascular Disease, Omega-3 Fatty Acids. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Repositioning Omega-3 Fatty Acids For Treatment Of Glycaemia And Cardiometabolic Disease
Overview
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.
Interventions
- Dietary supplement Omega-3 Fatty Acids
1500mg/day for 28 days - Drug Semaglutide 0.25 mg
0.25mg weekly for four weeks - Dietary supplement Placebo
Receive placebo
Primary outcome measures
- 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 outcome measures (12)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United Kingdom · 1 center
- School of Biomedical Sciences — Coleraine
Identifiers
NCT: NCT07677995 · 26/ES/0021 · TA/PPA/25/215037