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Completed

NCT Number: NCT01150292

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

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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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

55 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

First period DHA

Dietary Supplement

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

Second period DHA

Dietary Supplement

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

Primary outcomes

  1. Platelet function induced by collagen

    Time frame: 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 outcomes

  1. Evaluation of cellular and plasmatic redox status

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 24, 2010
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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