Free Fatty Acid Effects In Type 2 Diabetes
31 augusti 2026 uppdaterad av: University of Ulster
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.
Studieöversikt
Status
Anmälan via inbjudan
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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County Londonderry
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Coleraine, County Londonderry, Storbritannien, BT52 1SA
- School of Biomedical Sciences
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Placebo-jämförare: Placebo
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Receive placebo
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Experimentell: Omega-3 Fatty Acid Supplementation (EPA/DHA)
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1500mg/day for 28 days
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Experimentell: Omega-3 Fatty Acid Supplementation (ALA)
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1500mg/day for 28 days
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Experimentell: Omega-3 Fatty Acid Supplementation (EPA/DHA) and Semaglutide
Semaglutide is being used for comparison purposes only
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1500mg/day for 28 days
0.25mg weekly for four weeks
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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To evaluate the change in fasting glucose from baseline after 28 days of treatment, compared to each treatment group and placebo.
Tidsram: From baseline to 28 days of treatment
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From baseline to 28 days of treatment
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The change in insulin compared to placebo administration
Tidsram: From baseline to 28 days of treatment
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From baseline to 28 days of treatment
|
|
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The change in HbA1c compared to placebo administration
Tidsram: From baseline to 28 days of treatment
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From baseline to 28 days of treatment
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Glucose tolerance measurements during OGTT compared to placebo administration
Tidsram: From baseline to 28 days of treatment
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From baseline to 28 days of treatment
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|
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Area under the curve measurements during OGTT compared to placebo administration
Tidsram: From baseline to 28 days of treatment
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From baseline to 28 days of treatment
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|
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Plasma gut hormone concentrations (GLP-1, GIP, PYY, ghrelin, CCK and glucagon) compared to placebo administration
Tidsram: From baseline to 28 days of treatment
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From baseline to 28 days of treatment
|
|
|
Full lipid profile (cardiovascular risk markers) compared to placebo administration
Tidsram: From baseline to 28 days of treatment
|
From baseline to 28 days of treatment
|
|
|
Inflammatory and cardiovascular markers compared to placebo administration
Tidsram: From baseline to 28 days of treatment
|
Biomarkers include inflammatory markers (C-reactive protein [CRP], pro- and anti-inflammatory cytokines) and cardiovascular risk markers
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From baseline to 28 days of treatment
|
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Liver function tests (ALT and AST) compared to placebo administration
Tidsram: From baseline to 28 days of treatment
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From baseline to 28 days of treatment
|
|
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Body mass index (BMI) compared to placebo administration
Tidsram: From baseline to 28 days of treatment
|
Weight (kg) and height (m) will be combined to report BMI in kg/m^2
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From baseline to 28 days of treatment
|
|
Waist-to-hip circumference compared to placebo administration
Tidsram: From baseline to 28 days of treatment
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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
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From baseline to 28 days of treatment
|
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Blood pressure compared to placebo administration
Tidsram: From baseline to 28 days of treatment
|
From baseline to 28 days of treatment
|
|
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Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index compared to placebo administration
Tidsram: 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.
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From baseline to 28 days of treatment
|
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Change in Omega-3 Index (EPA and DHA as a percentage of total fatty acids) compared to placebo administration
Tidsram: From baseline to 28 days of treatment
|
From baseline to 28 days of treatment
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 december 2026
Avslutad studie (Beräknad)
1 februari 2027
Studieregistreringsdatum
Först inskickad
27 maj 2026
Först inskickad som uppfyllde QC-kriterierna
30 juni 2026
Första postat (Faktisk)
1 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
31 augusti 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Sjukdomar i det endokrina systemet
- Metaboliska sjukdomar
- Störningar i glukosmetabolism
- Diabetes mellitus
- Närings- och metabola sjukdomar
- Diabetes mellitus, typ 2
- Hjärt-kärlsjukdomar
- Fettsyror
- Lipider
- Fettsyror, omättade
- Oljor
- Kostfetter
- Fetter
- Kostfetter, omättade
- Fiskoljor
- semaglutid
- Fettsyror, omega-3
Andra studie-ID-nummer
- 26/ES/0021
- TA/PPA/25/215037 (Annat bidrag/finansieringsnummer: British Heart Foundation)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
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