Metabolic DiseasesNUMEVOXNCT00997165
Impact of Adipose Tissue Repartition on the Time Course of Vascular Dysfunction - the NUMEVOX Cohort
An observational study of Metabolic Diseases and Sleep Apnea, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metabolic Diseases, Sleep Apnea, Atherosclerosis
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2008to Mar 2017
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient suspected of metabolic syndrome with or without sleep apnea or liver steatosis. Informed consent with signature.
Who may be able to join
- informed consent
- age > 18 years old
- suspected of metabolic syndrome
- affiliated to french social health care
Who cannot join
- age < 18 years old
- pregnancy
- no informed consent
- not eligible for the study (no MS, cancer)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Pôle Maladies Métaboliques et Médecine Interne
Angers, 49993
GEORGES LEFTHERIOTIS, MD-PHD
FREDERIC GAGNADOUX, MD-PHD
About this study
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.
- Conditions
- Metabolic Diseases, Sleep Apnea, Atherosclerosis
- Keywords
- fatty liver, adipose tissue
- Medical subject headings
- Metabolic Diseases, Sleep Apnea Syndromes, Atherosclerosis, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startMar 2008
- Primary completionMar 2014 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Investigators
- pierre henri Ducluzeau, MD PhD, Study director, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997165
- Sponsor's protocol ID
- CHU-Promoteur 08-01
- Acronym
- NUMEVOX
- Status last verified
- Oct 2009
- First submitted
- 16 Oct 2009
- Last updated
- 19 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adipose Tissue Repartition on the Time Course of Vascular Dysfunction - the NUMEVOX Cohort
- ClinicalTrials.gov ID
- NCT00997165
- Acronym / sponsor ID
- NUMEVOX / CHU-Promoteur 08-01
- Conditions
- Metabolic Diseases, Sleep Apnea, Atherosclerosis
- Keywords
- fatty liver, adipose tissue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Mar 2008
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 19 Oct 2009 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient suspected of metabolic syndrome with or without sleep apnea or liver steatosis. Informed consent with signature.
Key inclusion criteria (4 listed)
- informed consent
- age > 18 years old
- suspected of metabolic syndrome
- affiliated to french social health care
Key exclusion criteria (4 listed)
- age < 18 years old
- pregnancy
- no informed consent
- not eligible for the study (no MS, cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2009.
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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.
pierre henri Ducluzeau, MD PhD study director
UH Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Diseases and Sleep Apnea, run by University Hospital, Angers at 1 site 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PIERRE HENRI DUCLUZEAU, MD PhD (33(0)663384160, phducluzeau@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 19 Oct 2009.