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

Civil Hospices of Lyon

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: First period DHA; Dietary Supplement: Second period DHA

Study type: Interventional

Funder types: Other

Identifiers

NCT01150292

2009.555

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Female

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 2 patient groups

DHA - Sunflower oil

Experimental group

Description:

400 mg DHA supplementation by day for 2 weeks then placebo for 2 weeks after a wash out period of 6 to 9 weeks

Treatment:

Dietary Supplement: First period DHA

Sunflower oil - DHA

Experimental group

Description:

Placebo during 2 weeks then 400 mg DHA supplementation by day for 2 weeks after a wash out period for 6 to 9 weeks

Treatment:

Dietary Supplement: Second period DHA