CompletedNot Applicable

Effects of Docosahexaenoic Acid (DHA) on Cardiovascular Disease on Diabetic Patients

France16 participantsStarted 2010-05

Plain-language summary

Aim: to determine the effects of DHA supplementation: * on the platelet function through their aggregation and the pathway of arachidonic acid metabolism * on redox status on cells and plasma * on inflammation in 16 type 2 diabetic patients in a cross-over study comparing DHA (400 mg/day for 2 weeks) vs Sunflower oil (placebo). Each period is separated by a wash-out period of 6 to 9 weeks.

Who can participate

Age range

55 Years – 75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * woman * Type 2 diabetes * Menopausal or aged between 55 and 75 years old * Recent HbA1c between 6.5-10% * Oral anti-diabetic drugs or insulin therapy * Hypertension or antihypertensive drug Exclusion Criteria: * Tobacco * Excessive drinking * Post-menopausal hormonal treatment * Treatment by acetylsalicylic acid, clopidogrel, gliclazide, ticlopidine, NSAID * Secondary cardiovascular prevention * antioxidant using * Fish intake \>2 times a week * Anemia \<10g/L * Thrombopenia \<110g/L * Creatinine clearance \<30 ml/min and/or proteinuria \>1g/L

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Platelet function induced by collagen

Timeframe: 4 blood sampling in 10 to 13 weeks

Trial details

NCT IDNCT01150292

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-02

View on ClinicalTrials.gov More Type 2 Diabetes trials