Effects of Different Fish Oil Types on Type 2 Diabetes Risk Factors in High-Risk Adults (NCT07575438)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (33 items).
Location: Institut de recherches cliniques de Montréal (IRCM) — Montreal, Quebec
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Institut de recherches cliniques de Montréal (IRCM) — Montreal, Quebec
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.