Impact of Adipose Tissue Repartition on the Time Course o... | NCT00997165

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

NCT00997165

Sponsor

University Hospital, Angers

Status

Unknown status

Last Update Posted

Oct 19, 2009Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Metabolic Diseases
Sleep Apnea
Atherosclerosis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Mar 2014Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

Oct 16, 2009

First Submission Date that Met QC Criteria

Oct 16, 2009

First Posted Date

Oct 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2009

Last Update Posted Date

Oct 19, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Informed consent with signature.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

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

Overall Officials

Name	Affiliation	Role
pierre henri Ducluzeau, MD PhD	UH Angers	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pôle Maladies Métaboliques et Médecine Interne	Recruiting	Angers		49993	France

Condition Browse Module

MeSH Terms

ID	Term
D008659	Metabolic Diseases
D012891	Sleep Apnea Syndromes
D050197	Atherosclerosis
D005234	Fatty Liver

Ancestor Terms

ID	Term
D009750	Nutritional and Metabolic Diseases
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided