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Impact of Adipose Tissue Repartition on the Time Course of Vascular Dysfunction - the NUMEVOX Cohort (NUMEVOX)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by University Hospital, Angers.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00997165
First Posted: October 19, 2009
Last Update Posted: October 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Angers
  Purpose
The NUMEVOX cohort is intended to follow-up the macro and microvascular dysfunction in relation to adipose tissue repartition in patients with metabolic syndrome associated to liver steatosis, sleep apnea. Duration of the follow-up is 3 years for each patient entering the cohort.

Condition
Metabolic Diseases Sleep Apnea Atherosclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Adipose Tissue Repartition on the Time Course of Vascular Dysfunction - the NUMEVOX Cohort

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Biospecimen Retention:   Samples With DNA
serum and DNA

Estimated Enrollment: 500
Study Start Date: March 2008
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Metabolic syndrome (MS)
Patients suspected of metabolic syndrome without sleep apnea or liver steatosis
MS with sleep apnea
Metabolic syndrome with sleep apnea
MS with Liver steatosis
Metabolic syndrome with liver steatosis

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any patient suspected of metabolic syndrome with or without sleep apnea or liver steatosis.

Informed consent with signature.

Criteria

Inclusion Criteria:

  • informed consent
  • age > 18 years old
  • suspected of metabolic syndrome
  • affiliated to french social health care

Exclusion Criteria:

  • age < 18 years old
  • pregnancy
  • no informed consent
  • not eligible for the study (no MS, cancer)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997165


Contacts
Contact: PIERRE HENRI DUCLUZEAU, MD PhD 33(0)663384160 phducluzeau@chu-angers.fr
Contact: GEORGES LEFTHERIOTIS, MD-PHD 33(2)41-35-44-56 geleftheriotis@chu-angers.fr

Locations
France
Pôle Maladies Métaboliques et Médecine Interne Recruiting
Angers, France, 49993
Sub-Investigator: GEORGES LEFTHERIOTIS, MD-PHD         
Sub-Investigator: FREDERIC GAGNADOUX, MD-PHD         
Sub-Investigator: PAUL CALES, MD-PHD         
Sponsors and Collaborators
University Hospital, Angers
Investigators
Study Director: pierre henri Ducluzeau, MD PhD UH Angers
  More Information

Responsible Party: Pierre Henri Ducluzeau/MD-PhD, UH Angers
ClinicalTrials.gov Identifier: NCT00997165     History of Changes
Other Study ID Numbers: CHU-Promoteur 08-01
First Submitted: October 16, 2009
First Posted: October 19, 2009
Last Update Posted: October 19, 2009
Last Verified: October 2009

Keywords provided by University Hospital, Angers:
fatty liver
adipose tissue

Additional relevant MeSH terms:
Atherosclerosis
Metabolic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases