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Effects of Different Fish Oil Types on Type 2 Diabetes Risk Factors in High-Risk Adults (END-T2D)

8 maja 2026 zaktualizowane przez: May Faraj, PDt, PhD

Role of EPA and DHA as Tailored Therapy for People Living With Obesity and High-risk for Type 2 Diabetes (END-T2D): a Randomized Controlled Trial

The purpose of this clinical trial is to find out whether one type of fish oil works better than another at improving metabolic health in people who are at high risk of developing type 2 diabetes.

Some metabolic problems-such as difficulty controlling blood sugar, unhealthy particles that transport cholesterol in the blood, and poor fat tissue function-can increase the risk of type 2 diabetes. This study aims to determine whether different types of fish oil can:

  1. Improve how well the body produces insulin and responds to it,
  2. Improve the quality of the particles that carry "bad" cholesterol in the blood, and 3) Improve the health and function of participants' fat tissue.

To answer these questions, researchers will compare the effects of two types of fish oil: EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid). These will be compared with corn oil, which is used as a placebo and does not contain EPA or DHA.

When included in this study, participants will:

A) Take softgel capsules containing EPA, DHA, or placebo (corn oil) every day for 12 weeks, B) Keep a daily log to record when they take their study softgels, and C) Visit the research unit six times, including one and a half days before and after the intervention, to complete specialized metabolic tests that are mostly only available in research settings.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Background and Rationale:

According to the International Diabetes Federation, about 590 million adults worldwide-or 1 in 9 adults-were living with diabetes in 2025, most of whom had type 2 diabetes (T2D). An additional 230 million adults (about 4 in 10) are unaware that they have diabetes and therefore remain undiagnosed. Diabetes substantially increases the risk of illness and death and has an impact comparable to aging approximately 15 years, making it a leading cause of disability and mortality worldwide.

Type 2 diabetes develops gradually as multiple risk factors accumulate over time, including unhealthy lifestyle habits and aging. These factors reduce the body's ability to produce insulin and/or respond effectively to insulin, a hormone that regulates blood sugar levels. As a result, blood sugar levels progressively rise and may eventually lead to a diagnosis of T2D.

Importantly, type 2 diabetes is preventable.

In people with T2D, elevated blood levels of apolipoprotein B (apoB) increase the risk of cardiovascular disease (apoB is a measure of the number of particles that carry "bad" cholesterol known as low density lipoproteins (LDL)). Traditionally, high apoB levels were considered a consequence of T2D. However, research from the principal investigator's laboratory has shown that high apoB levels may also contribute to the development of T2D.

This appears to occur because LDL particles can promote inflammation and impair the normal function of fat tissue. Poorly functioning fat tissue is associated with multiple metabolic abnormalities that increase the risk of both T2D and cardiovascular disease. Large population based studies confirmed that elevated blood apoB levels can predict the development of T2D many years before diagnosis.

Recent findings from the research team also indicate that 12 week supplementation with marine derived omega 3 fatty acids, EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid), can improve several risk factors for T2D, particularly in individuals with higher blood apoB levels. However, these data suggest that EPA and DHA may not provide identical benefits in reducing these risk factors.

Study Objective:

The overall aim of this study is to compare the effects of EPA versus DHA on major risk factors for T2D in adults with overweight or obesity and elevated blood apoB levels.

Study Design and Procedures:

After eligibility is confirmed, participants will visit the research institute (IRCM) for two baseline visits scheduled one week apart. During these visits, investigators will used specialized metabolic testing to:

  1. Assess how participants' bodies process glucose and produce insulin using blood samples, and
  2. Examine how participants' fat tissue responds to their own LDL using a small fat tissue biopsy.

Participants will then be randomly assigned to follow one of three interventions for 12 weeks: EPA, DHA or corn oil (placebo). At the end of the 12 week intervention, participants will return to the research institute to undergo the same assessments performed at baseline.

Data Analysis:

At the conclusion of the study, results from participants in each intervention group (EPA, DHA, and placebo) will be averaged and compared. This will allow researchers to determine the effects of EPA and DHA on key risk factors for T2D and to evaluate whether one omega 3 fatty acid is more effective than the other.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

84

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Kanada
    • Quebec
      • Montreal, Quebec, Kanada, H2W 1R7
        • Institut de recherches cliniques de Montréal (IRCM)
        • Kontakt:
        • Główny śledczy:
          • May Faraj, P.Dt., Ph.D.
        • Pod-śledczy:
          • Study physician: Remi Rabasa-Lhoret, M.D., Ph.D.

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

Inclusion Criteria:

Males and post-menopausal females:

  • With a body mass index (BMI >25-40 kg/m2)
  • Having confirmed menopausal status (FSH ≥ 30 U/l)
  • Non-smokers (tobacco) or have quitted for over a year
  • Low-moderate alcohol consumption: <7 alcoholic servings/ week
  • Plasma apoB ≥1.05 g/L

Exclusion Criteria:

  • Elevated risk of cardiovascular disease (≥ 20% of calculated Framingham Risk Score)
  • Prior history of cardiovascular events (e.g. stroke, transient ischemic attack, myocardial infarction, angina, heart failure, arrhythmias, flutter, atrial …)
  • Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg
  • Diabetes or HbA1c ≥ 6.5%
  • Reactive hypoglycaemia
  • Prior history of cancer within the last 3 years or if lymph nodes were removed
  • Thyroid disease - untreated or unstable Synthroid dose
  • Severe renal dysfunction - eGFR < 30 mL/min/1.73 m²
  • Hepatic dysfunction - AST/ALT > 3 times normal limit
  • Anemia - Hb < 120 g/L in females and < 130 in males
  • Bleeding disorders
  • Blood coagulation problems (i.e. bleeding predisposition)
  • Malabsorptive disease or surgeries (e.g. bariatric surgeries)
  • Autoimmune and chronic inflammatory disease (i.e. celiac, inflammatory bowel, Graves, multiple sclerosis, psoriasis, rheumatoid arthritis, and lupus).
  • Chronic diarrhea
  • Cholecystectomy (e.g. removal of gall bladder)
  • Sleep apnea
  • Seizures
  • Known history of difficulties accessing a vein
  • Known history of vagal shock or loss of consciousness during blood withdrawal
  • Concomitant medications (systemic corticosteroids; hypertension medication; anti-psychotic medications - psycho-active medication that promote weight gain; anticoagulant or anti-aggregates treatment (e.g. aspirin, NSAIDs, warfarin, coumadin..); systemic adrenergic agonists; weight-loss medication (e.g. GLP-1 agonists); lipid lowering medication (e.g. statins, anti-PCSK9); )
  • Allergy to seafood/fish or corn oil
  • Allergy to bovine gelatine or glycerine (softgel components)
  • Allergy to Xylocaine (anesthesia used during fat tissue biopsy)
  • Anticipated surgery or blood transfusion
  • Known substance abuse
  • Very high physical activity (> 5 hours of aerobic exercise per week)
  • Already taking more than 1 gm of EPA and/or DHA supplementation per day
  • Lack of compliance to the study requirements (i.e. not being fasting)
  • Cancellation of the same scheduled testing visit more than once
  • Lack of time to participate in the full length of the study (18-22 weeks)
  • Other conditions deemed inappropriate by the study physician (e.g. difficulties in understanding/communicating in French or English)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Eicosapentaenoic acid (EPA)
4 g EPA per day
Suplement diety: Fish Oil
Four softgels of Carlson Elite EPA Gems taken orally per day (NPN 80079735, 1 g EPA/softgel)
Suplement diety: Fish Oil
Four softgels of Carlson Elite DHA Gems taken orally per day (NPN 80079736, 1 g DHA/softgel)
Aktywny komparator: Docosahexaenoic acid (DHA)
4 g DHA per day
Suplement diety: Fish Oil
Four softgels of Carlson Elite EPA Gems taken orally per day (NPN 80079735, 1 g EPA/softgel)
Suplement diety: Fish Oil
Four softgels of Carlson Elite DHA Gems taken orally per day (NPN 80079736, 1 g DHA/softgel)
Komparator placebo: Corn oil
0 g EPA and DHA per day
Suplement diety: Corn oil control
Four softgels of Carlson placebo taken orally per day (food-grade corn oil, 0 g EPA and DHA per softgel)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline to 12 weeks in the disposition index
Ramy czasowe: 12-weeks
Disposition index calculated as first phase glucose-induced insulin secretion multiplied by insulin sensitivity measured during the Botnia clamp [(ng C-peptide/mL)*(mg dextrose/kg/min)/(µU insulin/mL)]
12-weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline to 12 weeks in glucose-induced insulin secretion
Ramy czasowe: 12 weeks
Glucose-induced insulin secretion measured by the Botnia clamp (ng C-peptide/mL)
12 weeks
Change from baseline to 12 weeks in insulin sensitivity
Ramy czasowe: 12 weeks
Insulin sensitivity measured by the Botnia clamp (mg dextrose/kg/min)/(uU insulin/mL)
12 weeks
Change from baseline to 12 weeks in the oral disposition index
Ramy czasowe: 12 week
Oral disposition index calculated as insulin secretion index (0-30 min) multiplied by insulin sensitivity index measured during an oral glucose tolerance test (arbitrary unit)
12 week
Change from baseline to 12 weeks in low-density lipoprotein (LDL) size
Ramy czasowe: 12 weeks
LDL size measured by Quantimetrix Lipoprint System (Å)
12 weeks
Change from baseline to 12 weeks in LDL-induced white adipose tissue (WAT) inflammation
Ramy czasowe: 12 weeks
LDL-induced WAT inflammation measured as WAT gene expression of a panel of pro- and anti-inflammatory mediators/markers (e.g. NLRP3, IL1B, MCP1, IL10, TREMs) by RT-qPCR. This will be measured after the incubation of participant WAT biopsies without or with their own LDL ex vivo.
12 weeks

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline to 12 weeks in LDL-induced WAT inflammation
Ramy czasowe: 12 weeks
LDL-induced WAT inflammation measured as WAT secretion of a panel of pro- and anti-inflammatory mediators/markers (e.g. IL-1β, MCP1, IL10) by multiplex. This will be measured after the incubation of participant WAT biopsies without or with their own LDL ex vivo.
12 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

May Faraj, PDt, PhD

Współpracownicy

Diabetes Canada

Śledczy

  • Główny śledczy: May Faraj, P.Dt., Ph.D., Institut de recherches cliniques de Montréal (IRCM)/ Université de Montréal

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2029

Ukończenie studiów (Szacowany)

1 grudnia 2029

Daty rejestracji na studia

Pierwszy przesłany

4 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 maja 2026

Pierwszy wysłany (Rzeczywisty)

8 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2026-1363
  • Award ID: EDA-25-1514974 (Inny numer grantu/finansowania: Diabetes Canada)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Frozen plasma and white adipose tissue samples (when available in sufficient quantity) may be shared with other investigators for analysis. However, all statistical analyses incorporating the complete participant data will be conducted exclusively by the IRCM research team, in accordance with the Information and Consent Form signed by the participants

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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