Type 2 Diabetes
Conditions
Keywords
DHA supplementation, Type 2 diabetic patient, Platelet function
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.
Interventions
DIETARY_SUPPLEMENTFirst period DHA
400 mg DHA supplementation by day for 2 weeks during the first study period
DIETARY_SUPPLEMENTSecond period DHA
400 mg DHA supplementation by day for 2 weeks during the second study period
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
France
Outcome results
None listed