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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: First period DHA; Dietary Supplement: Second period DHA

• Registration Number: NCT01150292
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-23
• Study First Submitted QC: 2010-06-23
• Study First Posted: 2010-06-24
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-02
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DHA - Sunflower oil	First period DHA	400 mg DHA supplementation by day for 2 weeks then placebo for 2 weeks after a wash out period of 6 to 9 weeks
Sunflower oil - DHA	Second period 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

Primary Outcome Measures

Name	Time	Method
Platelet function induced by collagen	4 blood sampling in 10 to 13 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Evaluation of cellular and plasmatic redox status	4 blood sampling in 10 to 13 weeks	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)

Trial Locations

Locations (2)

Centre de Recherche en Nutrition Humaine (CRNH) Rhône-Alpes; 🇫🇷 Pierre-benite, France

Hospices Civils de Lyon; 🇫🇷 Bron, France