Obesity, AbdominalR2C2-IINCT01716819
Role of the Renin Angiotensin Aldosterone System in the Mechanisms of Transition to Heart Failure in Abdominal Obesity
A study testing Urine sample, Blood sample and Assessment of sleep apnea syndrome in people with Obesity, Abdominal, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
R2C2 study has shown that abdominal obesity is associated with a cardiac and vascular remodelling in healthy volunteers. This remodelling is correlated with renin-angiotensin aldosterone system (RAAS) activation and/or systemic fibrosis. Read more about this study
- Who is it for?
- Ages 43 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Abdominal
- What is being tested?
- Urine sample, Blood sample and Assessment of sleep apnea syndrome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Mar 2015
- Phase
- Interventional
- 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 43 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a former member of R2C2 study, abdominal obese group.
- Having signed the informed consent (refusing to participate to the genetic study is not an exclusion criteria).
- being affiliated to health insurance scheme.
- Men and women aged between 40 and 65 year's old
- Caucasian
- Born or living in France for at least 10 years
- Presenting an abdominal obesity defined by a waist circumference >94 cm in men and ≥ 80 cm in women, associated or not with untreated hypertension or hypertension treated for less than one year
- Having signed the informed consent
Who cannot join
- Subjects unable to understand the information letter
- Subjects under supervision or guardianship
- pregnant or lactating woman
- A contraindication to perform MRI is not an exclusion criteria.
Trial locations and contacts
1 site in 1 country.
France1 site
CIC-P - INSERM - Institut Lorrain du Cœur et des vaisseaux
Vandœuvre-lès-Nancy, Meurthe et Moselle, 54500
About this study
Official title: Role of the Renin Angiotensin Aldosterone System and Remodeling of the Matrix Cardiac Extra Cellular in the Mechanisms of Transition to Heart Failure in Abdominal Obesity: Prospective Longitudinal Study R2C2 II
R2C2 study has shown that abdominal obesity is associated with a cardiac and vascular remodelling in healthy volunteers. This remodelling is correlated with renin-angiotensin aldosterone system (RAAS) activation and/or systemic fibrosis. R2C2 II study is designed to confirm the hypothesis that RAAS is associated with an early remodelling and implicated in the transition to cardiac failure in abdominal obesity.
Read the detailed description
Follow up of abdominal obesity patients from the R2C2 cohort study.
- Conditions
- Obesity, Abdominal
- Being tested
- Urine sample, Blood sample, Assessment of sleep apnea syndrome, Electrocardiogram, Glucose tolerance test
- Keywords
- Heart failure, abdominal obesity, RAAS
- Medical subject headings
- Obesity, Abdominal, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine sampleOther
dosages on one spot and 24h collection
Blood sampleOther
dosages
Assessment of sleep apnea syndromeOther
ElectrocardiogramOther
Glucose tolerance testOther
EchocardiographyOther
cardiac and abdominal magnetic resonance imagingOther
Ambulatory blood pressure monitoringOther
EchotrackingOther
Pulse wave velocityOther
Composition of body mass by Dual x-ray absorptiometryOther
| Study group | Role | What they receive |
|---|---|---|
| Abdominal obesity | Other | Single arm, follow up cohort in patient with abdominal obesity. No comparator: description of interventions :
Composition of body mass by Dual x-ray absorptiometry Pulse wave velocity Electrocardiogram Urine sample Blood sample (and biological collection) Assessment of sleep apnea syndrome Glucose tolerance test Echocardiography Echotracking cardiac and abdominal magnetic resonance imaging Ambulatory blood pressure monitoring Receives: Other: Urine sample; Other: Blood sample; Other: Assessment of sleep apnea syndrome; Other: Electrocardiogram; Other: Glucose tolerance test; Other: Echocardiography; Other: cardiac and abdominal magnetic resonance imaging; Other: Ambulatory blood pressure monitoring; Other: Echotracking; Other: Pulse wave velocity; Other: Composition of body mass by Dual x-ray absorptiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac extracellular matrix remodelling
Initial values of cardiac extracellular matrix remodelling biomarkers and the evolution of biomarkers at 3-7 years
Measured: 3-7 years
Secondary outcomes (1)
Cardiac and arterial phenotype
Evolution of cardiac and vascular phenotype in 3-7 years.
Measured: 3-7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick ROSSIGNOL, Principal investigator, CIC-P - INSERM - Institut Lorrain du Cœur et des vaisseaux Louis Mathieu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716819
- Sponsor's protocol ID
- 2012-A00574-39
- Acronym
- R2C2-II
- Status last verified
- Aug 2015
- First submitted
- 26 Oct 2012
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mandry D, Girerd N, Lamiral Z, Huttin O, Filippetti L, Micard E, Beaumont M, Ncho Mottoh MB, Pace N, Zannad F, Rossignol P, Marie PY. Relationship Between Left Ventricular Ejection Fraction Variation and Systemic Vascular Resistance: A Prospective Cardiovascular Magnetic Resonance Study. Front Cardiovasc Med. 2021 Dec 24;8:803567. doi: 10.3389/fcvm.2021.803567. eCollection 2021.
PubMed 35004914
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Renin Angiotensin Aldosterone System and Remodeling of the Matrix Cardiac Extra Cellular in the Mechanisms of Transition to Heart Failure in Abdominal Obesity: Prospective Longitudinal Study R2C2 II
- ClinicalTrials.gov ID
- NCT01716819
- Acronym / sponsor ID
- R2C2-II / 2012-A00574-39
- Conditions
- Obesity, Abdominal
- Keywords
- Heart failure, abdominal obesity, RAAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 30 Oct 2012 (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.
R2C2 study has shown that abdominal obesity is associated with a cardiac and vascular remodelling in healthy volunteers. This remodelling is correlated with renin-angiotensin aldosterone system (RAAS) activation and/or systemic fibrosis. R2C2 II study is designed to confirm the hypothesis that RAAS is associated with an early remodelling and implicated in the transition to cardiac failure in abdominal obesity.
Detailed description
Follow up of abdominal obesity patients from the R2C2 cohort study.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal obesity | Other | Other: Urine sample, Other: Blood sample, Other: Assessment of sleep apnea syndrome, Other: Electrocardiogram, Other: Glucose tolerance test, Other: Echocardiography, Other: cardiac and abdominal magnetic resonance imaging, Other: Ambulatory blood pressure monitoring, Other: Echotracking, Other: Pulse wave velocity, Other: Composition of body mass by Dual x-ray absorptiometrySingle arm, follow up cohort in patient with abdominal obesity. No comparator: description of interventions : Composition of body mass by Dual x-ray absorptiometry Pulse wave velocity Electrocardiogram Urine sample Blood sample (and biological collection) Assessment of sleep apnea syndrome Glucose tolerance test Echocardiography Echotracking cardiac and abdominal magnetic resonance imaging Ambulatory blood pressure monitoring |
Who may qualify
- Ages
- 43 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being a former member of R2C2 study, abdominal obese group.
- Having signed the informed consent (refusing to participate to the genetic study is not an exclusion criteria).
- being affiliated to health insurance scheme.
- Men and women aged between 40 and 65 year's old
- Caucasian
Key exclusion criteria (4 listed)
- Subjects unable to understand the information letter
- Subjects under supervision or guardianship
- pregnant or lactating woman
- A contraindication to perform MRI is not an exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine sampledosages on one spot and 24h collection | Other | Abdominal obesity |
| Blood sampledosages | Other | Abdominal obesity |
| Assessment of sleep apnea syndrome | Other | Abdominal obesity |
| Electrocardiogram | Other | Abdominal obesity |
| Glucose tolerance test | Other | Abdominal obesity |
| Echocardiography | Other | Abdominal obesity |
| cardiac and abdominal magnetic resonance imaging | Other | Abdominal obesity |
| Ambulatory blood pressure monitoring | Other | Abdominal obesity |
| Echotracking | Other | Abdominal obesity |
| Pulse wave velocity | Other | Abdominal obesity |
| Composition of body mass by Dual x-ray absorptiometry | Other | Abdominal obesity |
Primary outcome
cardiac extracellular matrix remodelling
Time frame: 3-7 years
Initial values of cardiac extracellular matrix remodelling biomarkers and the evolution of biomarkers at 3-7 years
1 secondary outcome
Cardiac and arterial phenotype
Time frame: 3-7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
- Derived from this study: PubMed 35004914Mandry D, Girerd N, Lamiral Z, Huttin O, Filippetti L, Micard E, Beaumont M, Ncho Mottoh MB, Pace N, Zannad F, Rossignol P, Marie PY. Relationship Between Left Ventricular Ejection Fraction Variation and Systemic Vascular Resistance: A Prospective Cardiovascular Magnetic Resonance Study. Front Cardiovasc Med. 2021 Dec 24;8:803567. doi: 10.3389/fcvm.2021.803567. eCollection 2021.
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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.
Patrick ROSSIGNOL principal investigator
CIC-P - INSERM - Institut Lorrain du Cœur et des vaisseaux Louis Mathieu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine sample, Blood sample and Assessment of sleep apnea syndrome in people with Obesity, Abdominal, run by Central Hospital, Nancy, France 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 8 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: finished, as of the sponsor's last update on 24 Aug 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac extracellular matrix remodelling (time frame: 3-7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01716819, which also lists 1 linked publication.
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 24 Aug 2015.