NCT01150292

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started May 2010

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

May 28, 2019

Status Verified

February 1, 2014

Enrollment Period

2.8 years

First QC Date

June 23, 2010

Last Update Submit

May 23, 2019

Conditions

Type 2 Diabetes

Keywords

DHA supplementationType 2 diabetic patientPlatelet function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Evaluation of cellular and plasmatic redox status

    4 blood sampling in 10 to 13 weeks

Study Arms (2)

DHA - Sunflower oil

EXPERIMENTAL

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

Sunflower oil - DHA

EXPERIMENTAL

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

Interventions

First period DHADIETARY_SUPPLEMENT

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

DHA - Sunflower oil
Second period DHADIETARY_SUPPLEMENT

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

Sunflower oil - DHA

Eligibility Criteria

Age55 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospices Civils de Lyon

Bron, France

Location

Centre de Recherche en Nutrition Humaine (CRNH) Rhône-Alpes

Pierre-Bénite, France

Location

Related Publications (1)

  • Vericel E, Colas R, Calzada C, Le 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 Aug;114(2):289-96. doi: 10.1160/TH14-12-1003. Epub 2015 Apr 2.

    PMID: 25832443RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Martine LAVILLE, MD, PhD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2010

First Posted

June 24, 2010

Study Start

May 1, 2010

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

May 28, 2019

Record last verified: 2014-02

Locations

FR(2)