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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-02-28

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.

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DHA - Sunflower oil

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

Group Type EXPERIMENTAL

First period DHA

Intervention Type DIETARY_SUPPLEMENT

400 mg DHA supplementation by day for 2 weeks during the first study period

Sunflower oil - DHA

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

Group Type EXPERIMENTAL

Second period DHA

Intervention Type DIETARY_SUPPLEMENT

400 mg DHA supplementation by day for 2 weeks during the second study period

Interventions

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First period DHA

400 mg DHA supplementation by day for 2 weeks during the first study period

Intervention Type DIETARY_SUPPLEMENT

Second period DHA

400 mg DHA supplementation by day for 2 weeks during the second study period

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No