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Vascular Impact of Omega-3 in Metabolic Syndrome (CARDIOMEGA)

This study is currently recruiting participants.
Verified June 2012 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01566188
First received: December 8, 2011
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
  Purpose

The overall aims of the present project are to investigate the impact of a nutritional approach based on omega-3 from vegetal origin on vascular function in hypertension associated with metabolic syndrome.


Condition Intervention
Essential Hypertension
Metabolic Syndrome
 Dietary Supplement: omega-3 from vegetal origin
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Cardiovascular Impact of Omega-3 Dietary Supplement From Vegetal Origin in Hypertension Associated With Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Brachial artery flow-mediated dilatation [ Time Frame: 6 months after omega-3 supplementation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Aortic stiffness [ Time Frame: 6 months after omega-3 supplementation ] [ Designated as safety issue: No ]
    carotid-to-femoral pulse wave velocity


Estimated Enrollment: 120
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: omega-3 from vegetal origin Dietary Supplement: omega-3 from vegetal origin
6 months of supplementation with omega-3 from vegetal origin
Other Name: Cyclodextrin/Camelin oil
Placebo Comparator: Placebo Dietary Supplement: Placebo
6 months of supplementation with placebo
Other Name: Cyclodextrin/Starch

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female and male patients with treated essential hypertension (blood pressure values<140/90 mmHg under antihypertensive treatment).
  • Presence of at least two of the following criteria of the metabolic syndrome: abdominal girth >102 cm in men or >88 cm in women, HDL-C<0.4 g/L in men or <0.5 g/L in women, fasting triglyceride >1.5 g/L (or specific treatment for these lipid abnormalities), fasting glucose >1.10 g/L.

Exclusion Criteria:

  • Secondary hypertension, myocardial infarction, coronary artery disease, cerebrovascular disease, stroke or transient ischemia, cardiac failure, diabetes (or fasting glucose>1.26 g/L) or renal failure (MDRD < 50 ml/min)
  • Severe hypercholesterolemia (total cholesterol > 2.5 g/l), alcohol or drug abuse, toxicomania, or clinically significant abnormalities in other current biological parameters.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566188

Contacts
Contact: Robinson Joannides, MD, PhD +33232889141 robinson.joannides@chu-rouen.fr

Locations
France
Mahes Hospital Recruiting
Fleury-Mérogis, France, 91700
Contact: Bruno Pannier, MD, PhD     +33169256514     bpannier@club-internet.fr    
Principal Investigator: Bruno Pannier, MD, PhD            
George Pompidou European Hospital Recruiting
Paris, France, 75000
Contact: Pierre Boutouyrie, MD, PhD     +33153988021     pierre.boutouyrie@egp.aphp.fr    
Principal Investigator: Pierre Boutouyrie, MD, PhD            
Rouen University Hospital Recruiting
Rouen, France, 76031
Contact: Jeremy Bellien, PharmD, PhD     +33232881428     jeremy.bellien@chu-rouen.fr    
Sub-Investigator: Jeremy Bellien, PharmD, PhD            
Rangueil University Hospital Recruiting
Toulouse, France, 31059
Contact: Alessandra , Bura-Riviere     +33561322438     bura-riviere.a@chu-toulouse.fr    
Principal Investigator: Alessandra Bura-Riviere, MD, PhD            
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Robinson Joannides, MD, PhD Rouen University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01566188     History of Changes
Other Study ID Numbers: 2010/010 HP
Study First Received: December 8, 2011
Last Updated: June 13, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Hypertension
Metabolic Syndrome X
Vascular Diseases
Cardiovascular Diseases
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013