Fish Oil for Type 2 Diabetes

(END-T2D Trial)

JF
Cc
Overseen ByClinical coordinator and nurse
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether different types of fish oil can improve metabolic health in individuals at high risk of developing type 2 diabetes. It compares two types of fish oil, EPA and DHA, to determine which better aids insulin production and response, improves cholesterol levels, and enhances fat tissue health. Participants will take fish oil or a placebo (a harmless substitute) daily for 12 weeks and visit the research center for tests. This study may suit men and post-menopausal women who are non-smokers, have a higher body mass index (BMI), and are not managing diabetes. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop taking certain medications, such as those for hypertension, weight loss, or cholesterol, as well as blood thinners and some other specific drugs. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fish oil components, DHA and EPA, are under study for their effects on type 2 diabetes. Some studies suggest that DHA might raise blood sugar levels in individuals with type 2 diabetes. However, other research indicates that DHA is generally safe at recommended doses and does not cause major side effects.

EPA, in contrast, may help with issues related to type 2 diabetes, such as reducing inflammation and improving blood vessel function. Consuming more than 3 grams a day, however, could slow blood clotting, posing a risk. Both DHA and EPA are commonly found in supplements and are usually well-tolerated, but awareness of these possible effects is important.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for Type 2 Diabetes, which often include medications like metformin and insulin to manage blood sugar levels, fish oil treatments like Docosahexaenoic acid (DHA) and Eicosapentaenoic acid (EPA) offer a unique approach. These omega-3 fatty acids are derived from fish oil and are known for their potential anti-inflammatory properties, which could benefit people with Type 2 Diabetes by improving heart health and possibly aiding in glucose management. Researchers are particularly excited about DHA and EPA because they might offer added cardiovascular protection, a significant concern for diabetics. This approach not only targets blood sugar levels but also addresses associated risks, providing a more holistic treatment option.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

This trial will compare the effects of two types of fish oil, EPA and DHA, on health markers related to type 2 diabetes. Studies have shown that both EPA and DHA may improve certain health markers. Research indicates that EPA can enhance insulin effectiveness and reduce some blood markers linked to diabetes. DHA has improved fat tissue health and may lower harmful blood fats. However, neither EPA nor DHA consistently improves blood sugar levels in individuals with existing type 2 diabetes. Both types of fish oil have shown potential in reducing the risk of developing type 2 diabetes, particularly in those with high levels of certain blood fats.12678

Who Is on the Research Team?

MF

May Faraj, P.Dt., Ph.D.

Principal Investigator

Institut de recherches cliniques de Montréal (IRCM)/ Université de Montréal

Are You a Good Fit for This Trial?

This trial is for adults with a BMI between 25 and 40, who are postmenopausal, do not smoke or have quit smoking for over a year, drink less than 7 alcoholic drinks per week, and have higher levels of a cholesterol-related blood marker (apoB).

Inclusion Criteria

* 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
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo specialized metabolic testing to assess glucose processing and fat tissue response

1 week
2 visits (in-person)

Treatment

Participants take softgel capsules containing EPA, DHA, or placebo daily for 12 weeks

12 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Fish Oil

Trial Overview

The study compares two types of fish oil supplements (EPA and DHA) to corn oil (placebo) in people at high risk for type 2 diabetes. Participants take daily capsules for 12 weeks to see which supplement best improves insulin function, cholesterol particles, and fat tissue health.

How Is the Trial Designed?

3

Treatment groups

Active Control

Placebo Group

Group I: Docosahexaenoic acid (DHA)Active Control1 Intervention
Group II: Eicosapentaenoic acid (EPA)Active Control1 Intervention
Group III: Corn oilPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

May Faraj, PDt, PhD

Lead Sponsor

Trials
1
Recruited
40+

Diabetes Canada

Collaborator

Trials
13
Recruited
1,200+

Citations

Dietary Docosahexaenoic Acid-Rich Supplementation ... - PMC

This study investigates whether DHA-rich supplementation reduces neurotoxic lipid mediators associated with pDN in individuals with type 2 diabetes mellitus ( ...

Effects of purified eicosapentaenoic and docosahexaenoic ...

In summary, this study showed that over 6 wk both EPA and DHA led to a mild impairment of glycemic control in moderately obese type 2 diabetic patients with ...

Docosahexaenoic acid has an anti-diabetic effect in ... - PMC

When treated with DHA, diabetic mice showed remarkably higher hepatic SOD activities compared with those in the diabetic control group. These results indicate ...

Dietary Docosahexaenoic Acid and Glucose Systemic ...

These findings demonstrate that DHA feeding in mice alters macronutrient metabolism and may restore ECS tone by lowering arachidonic acid derived eCB.

Associations of eicosapentaenoic acid and ...

This study aimed to investigate the relationship between EPA and DHA intakes with all-cause and cause-specific mortality in adults with diabetes.

Docosahexaenoic Acid (Dha) - Uses, Side Effects, and More

Diabetes: DHA seems to increase blood sugar in some people with type 2 diabetes. Interactions. Moderate Interaction. Be cautious with this ...

Effects of Docosahexaenoic Acid (DHA) on Cardiovascular ...

Type 2 diabetes; Menopausal or aged between 55 and 75 years old; Recent HbA1c ... Moderate oral supplementation with docosahexaenoic acid improves platelet ...

Scientific Opinion on the tolerable upper intake level for ...

This safe level of intake is based on long-term human intervention studies that have generally not reported adverse effects of supplemental DHA ...