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

Study Overview
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Brief Summary
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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.

Official Title
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Intake of Low Dose of Docosahexaenoic Acid: Effects on Platelet Functions and Redox Status in Diabetic Patients

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: First period DHA
* Dietary Supplement: Second period DHA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHA - Sunflower oil<br>400 mg DHA supplementation by day for 2 weeks then placebo for 2 weeks after a wash out period of 6 to 9 weeks | Dietary Supplement: First period DHA<br>* 400 mg DHA supplementation by day for 2 weeks during the first study period<br>|
| Experimental: Sunflower oil - DHA<br>Placebo during 2 weeks then 400 mg DHA supplementation by day for 2 weeks after a wash out period for 6 to 9 weeks | Dietary Supplement: Second period DHA<br>* 400 mg DHA supplementation by day for 2 weeks during the second study period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet function induced by collagen | 4 blood sampling are made during the time of study which expand from 10 weeks (washout period of 6 weeks) to 13 weeks (washout period of 9 weeks): first at the beginning of the first period second at the end of the period (2 weeks after beginning) third at the beginning of the second period fourth at the end of the period (2 weeks after beginning) | 4 blood sampling in 10 to 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of cellular and plasmatic redox status | blood sampling are made during the time of study which expand from 10 weeks (washout period of 6 weeks) to 13 weeks (washout period of 9 weeks): first at the beginning of the first period second at the end of the period (2 weeks after beginning) third at the beginning of the second period fourth at the end of the period (2 weeks after beginning) | 4 blood sampling in 10 to 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DHA supplementation, Type 2 diabetic patient, Platelet function