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

This study is currently recruiting participants.
Verified October 2009 by University Hospital, Angers
Sponsor:
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00997165
First received: October 16, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Pierre Henri Ducluzeau/MD-PhD, UH Angers
ClinicalTrials.gov Identifier: NCT00997165     History of Changes
Other Study ID Numbers: CHU-Promoteur 08-01
Study First Received: October 16, 2009
Last Updated: October 16, 2009
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Metabolic Diseases
Apnea
Atherosclerosis
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013