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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150292
• Other study ID #: 2009.555
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: February 2013

Study information

• Verified date: February 2014
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Dietary Supplement:
• First period DHA
400 mg DHA supplementation by day for 2 weeks during the first study period
• Second period DHA
400 mg DHA supplementation by day for 2 weeks during the second study period

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Bron
France	Centre de Recherche en Nutrition Humaine (CRNH) Rhône-Alpes	Pierre-benite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

Véricel E, Colas R, Calzada C, Lê QH, Feugier N, Cugnet C, Vidal H, Laville M, Moulin P, Lagarde M. Moderate oral supplementation with docosahexaenoic acid improves platelet function and oxidative stress in type 2 diabetic patients. Thromb Haemost. 2015 A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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