Type 2 DiabetesNCT01150292
Effects of Docosahexaenoic Acid (DHA) on Cardiovascular Disease on Diabetic Patients
A study testing First period DHA and Second period DHA in people with Type 2 Diabetes, run by Hospices Civils de Lyon at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 55 to 75 years, women only
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- First period DHA and Second period DHA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesFrance
- Study dates
- May 2010to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Tobacco
- Excessive drinking
- Post-menopausal hormonal treatment
- Treatment by acetylsalicylic acid, clopidogrel, gliclazide, ticlopidine, NSAID
- Secondary cardiovascular prevention
- antioxidant using
Show all 10Show fewer
- Fish intake >2 times a week
- Anemia <10g/L
- Thrombopenia <110g/L
- Creatinine clearance <30 ml/min and/or proteinuria >1g/L
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospices Civils de Lyon
Bron
Centre de Recherche en Nutrition Humaine (CRNH) Rhône-Alpes
Pierre-Bénite
About this study
Official title: Intake of Low Dose of Docosahexaenoic Acid: Effects on Platelet Functions and Redox Status in 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.
- Conditions
- Type 2 Diabetes
- Being tested
- First period DHA, Second period DHA
- Keywords
- DHA supplementation, Type 2 diabetic patient, Platelet function
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First period DHADietary supplement
400 mg DHA supplementation by day for 2 weeks during the first study period
Second period DHADietary supplement
400 mg DHA supplementation by day for 2 weeks during the second study period
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Second period DHA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 blood sampling in 10 to 13 weeks
Secondary outcomes (1)
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)
Measured: 4 blood sampling in 10 to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine LAVILLE, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150292
- Sponsor's protocol ID
- 2009.555
- Status last verified
- Feb 2014
- First submitted
- 23 Jun 2010
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25832443
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intake of Low Dose of Docosahexaenoic Acid: Effects on Platelet Functions and Redox Status in Diabetic Patients
- ClinicalTrials.gov ID
- NCT01150292
- Acronym / sponsor ID
- 2009.555
- Conditions
- Type 2 Diabetes
- Keywords
- DHA supplementation, Type 2 diabetic patient, Platelet function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA - Sunflower oil | Experimental | Dietary Supplement: First period DHA400 mg DHA supplementation by day for 2 weeks then placebo for 2 weeks after a wash out period of 6 to 9 weeks |
| Sunflower oil - DHA | Experimental | Dietary Supplement: Second period DHAPlacebo during 2 weeks then 400 mg DHA supplementation by day for 2 weeks after a wash out period for 6 to 9 weeks |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- Tobacco
- Excessive drinking
- Post-menopausal hormonal treatment
- Treatment by acetylsalicylic acid, clopidogrel, gliclazide, ticlopidine, NSAID
- Secondary cardiovascular prevention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First period DHA400 mg DHA supplementation by day for 2 weeks during the first study period | Dietary supplement | DHA - Sunflower oil |
| Second period DHA400 mg DHA supplementation by day for 2 weeks during the second study period | Dietary supplement | Sunflower oil - DHA |
Primary outcome
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)
1 secondary outcome
Evaluation of cellular and plasmatic redox status
Time frame: 4 blood sampling in 10 to 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Results publication: PubMed 25832443Vericel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine LAVILLE, MD, PhD principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First period DHA and Second period DHA in people with Type 2 Diabetes, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet function induced by collagen (time frame: 4 blood sampling in 10 to 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01150292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.