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Free Fatty Acid Effects In Type 2 Diabetes

30. juni 2026 opdateret af: 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.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
    • County Londonderry
      • Coleraine, County Londonderry, Det Forenede Kongerige, BT52 1SA
        • School of Biomedical Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Kosttilskud: Placebo
Receive placebo
Eksperimentel: Omega-3 Fatty Acid Supplementation (EPA/DHA)
Kosttilskud: Omega-3 Fatty Acids
1500mg/day for 28 days
Eksperimentel: Omega-3 Fatty Acid Supplementation (ALA)
Kosttilskud: Omega-3 Fatty Acids
1500mg/day for 28 days
Eksperimentel: Omega-3 Fatty Acid Supplementation (EPA/DHA) and Semaglutide
Semaglutide is being used for comparison purposes only
Kosttilskud: Omega-3 Fatty Acids
1500mg/day for 28 days
Medicin: Semaglutide 0.25 mg
0.25mg weekly for four weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
To evaluate the change in fasting glucose from baseline after 28 days of treatment, compared to each treatment group and placebo.
Tidsramme: From baseline to 28 days of treatment
From baseline to 28 days of treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The change in insulin compared to placebo administration
Tidsramme: From baseline to 28 days of treatment
From baseline to 28 days of treatment
The change in HbA1c compared to placebo administration
Tidsramme: From baseline to 28 days of treatment
From baseline to 28 days of treatment
Glucose tolerance measurements during OGTT compared to placebo administration
Tidsramme: From baseline to 28 days of treatment
From baseline to 28 days of treatment
Area under the curve measurements during OGTT compared to placebo administration
Tidsramme: From baseline to 28 days of treatment
From baseline to 28 days of treatment
Plasma gut hormone concentrations (GLP-1, GIP, PYY, ghrelin, CCK and glucagon) compared to placebo administration
Tidsramme: From baseline to 28 days of treatment
From baseline to 28 days of treatment
Full lipid profile (cardiovascular risk markers) compared to placebo administration
Tidsramme: From baseline to 28 days of treatment
From baseline to 28 days of treatment
Inflammatory and cardiovascular markers compared to placebo administration
Tidsramme: From baseline to 28 days of treatment
Biomarkers include inflammatory markers (C-reactive protein [CRP], pro- and anti-inflammatory cytokines) and cardiovascular risk markers
From baseline to 28 days of treatment
Liver function tests (ALT and AST) compared to placebo administration
Tidsramme: From baseline to 28 days of treatment
From baseline to 28 days of treatment
Body mass index (BMI) compared to placebo administration
Tidsramme: From baseline to 28 days of treatment
Weight (kg) and height (m) will be combined to report BMI in kg/m^2
From baseline to 28 days of treatment
Waist-to-hip circumference compared to placebo administration
Tidsramme: 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
From baseline to 28 days of treatment
Blood pressure compared to placebo administration
Tidsramme: From baseline to 28 days of treatment
From baseline to 28 days of treatment
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index compared to placebo administration
Tidsramme: 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.
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
Tidsramme: From baseline to 28 days of treatment
From baseline to 28 days of treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Ulster

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. februar 2027

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

30. juni 2026

Først opslået (Faktiske)

1. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 26/ES/0021
  • TA/PPA/25/215037 (Andet bevillings-/finansieringsnummer: British Heart Foundation)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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