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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01150292
First received: June 23, 2010
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.

Condition Intervention
Type 2 Diabetes
Dietary Supplement: First period DHA
Dietary Supplement: Second period DHA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Intake of Low Dose of Docosahexaenoic Acid: Effects on Platelet Functions and Redox Status in Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Platelet function induced by collagen [ Time Frame: 4 blood sampling in 10 to 13 weeks ] [ Designated as safety issue: No ]

    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:
  • Evaluation of cellular and plasmatic redox status [ Time Frame: 4 blood sampling in 10 to 13 weeks ] [ Designated as safety issue: No ]

    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)



Enrollment: 16
Study Start Date: May 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Dietary Supplement: First period DHA
400 mg DHA supplementation by day for 2 weeks during the first study period
Experimental: 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
Dietary Supplement: Second period DHA
400 mg DHA supplementation by day for 2 weeks during the second study period

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01150292

Locations
France
Hospices Civils de Lyon
Bron, France
Centre de Recherche en Nutrition Humaine (CRNH) Rhône-Alpes
Pierre-benite, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Martine LAVILLE, MD, PhD Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01150292     History of Changes
Other Study ID Numbers: 2009.555
Study First Received: June 23, 2010
Last Updated: February 6, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
DHA supplementation
Type 2 diabetic patient
Platelet function

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014