Body Weight ChangesVALCORNCT04464278
Variation in Body Composition on the Fate of Older Subjects During SSR Hospitalization
An observational study of Body Weight Changes, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The aim of this study is to correlate weight variation as well as body composition with mortality and unscheduled readmission of geriatric population Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Body Weight Changes
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Oct 2023
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Geriatric population hospitalized in geriatric department at Rothschild and Emile-Roux hospitals
Who may be able to join
- Patient ≥70 years old
- Hospitalized in SSR for less than 7 days
- No patient opposition
Who cannot join
- patient with a pacemaker
- lake of nutritional assessment on admission
- lake of assessment of autonomy at admission
- Patient under guardianship or curatorship
- Patient participating in another clinical research
- Patient for whom a short stay (<21 days) is planned in SSR
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Predictive Value of Variation in Body Composition on the Fate of Older Subjects During SSR Hospitalization (Suite Care and Rehabilitation)
The aim of this study is to correlate weight variation as well as body composition with mortality and unscheduled readmission of geriatric population
Read the detailed description
Weight loss in obese adults confers health benefits, while weight loss in the elderly is associated with an increased risk of mortality.
There are a large number of studies associating weight loss and mortality but the relationships between changes in body composition (ratio between fat mass and lean mass) and mortality are often contradictory and poorly understood in elderly subject. The aim at this study is to request at this question.
- Conditions
- Body Weight Changes
- Keywords
- Geriatric, Suite Care and Rehabilitation, Body composition
- Medical subject headings
- Body Weight Changes
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 |
|---|---|---|
| Case group: weight loss ≥ 5% | Not described | |
| Control group: weight loss ≤ 5% | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prognosis value of variation of weight on mortality
Determination of variation of weight between D0 and D21 after inclusion
Measured: 3 months
Mortality rate
Monitoring of survival at 3 months after inclusion
Measured: 3 months
Secondary outcomes (5)
The pprognosis value of variation of weight on unscheduled readmission in SSR
Determination of variation of weight between D0 and D21 after inclusion
Measured: Between D0 and D21
Unscheduled readmission in SSR
Monitoring of unscheduled readmission during 15 days after the end of hospitalization
Measured: during 15 days after the end of hospitalization
Lean mass pronostic value
Determine the prognosis value of variation in lean mass on mortality and unscheduled readmission in SSR within 15 days of end of hospitalization
Measured: 3 months after the inclusion
In fat mass pronostic value
Determine the prognosis value of variation in fat mass on mortality and unscheduled readmission in SSR within 15 days of end of hospitalization
Measured: 3 months after the inclusion
fat / lean mass ratio
Determine the prognosis value of fat / lean mass ratio on mortality and unscheduled readmission in SSR within 15 days of end of hospitalization
Measured: 3 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study startJul 2020 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM UMR S 1136
- Responsible party
- Sponsor
- Investigators
- Christine FORASASSI, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464278
- Sponsor's protocol ID
- APHP200265
- Other IDs
- IDRCB 2019-A03287-50
- Acronym
- VALCOR
- Status last verified
- Jul 2020
- First submitted
- 8 Jun 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Variation in Body Composition on the Fate of Older Subjects During SSR Hospitalization (Suite Care and Rehabilitation)
- ClinicalTrials.gov ID
- NCT04464278
- Acronym / sponsor ID
- VALCOR / APHP200265
- Conditions
- Body Weight Changes
- Keywords
- Geriatric, Suite Care and Rehabilitation, Body composition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- INSERM UMR S 1136
- Study start
- Jul 2020 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 9 Jul 2020 (actual)
- 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 aim of this study is to correlate weight variation as well as body composition with mortality and unscheduled readmission of geriatric population
Detailed description
Weight loss in obese adults confers health benefits, while weight loss in the elderly is associated with an increased risk of mortality.
There are a large number of studies associating weight loss and mortality but the relationships between changes in body composition (ratio between fat mass and lean mass) and mortality are often contradictory and poorly understood in elderly subject. The aim at this study is to request at this question.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group: weight loss ≥ 5% | – | – |
| Control group: weight loss ≤ 5% | – | – |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Geriatric population hospitalized in geriatric department at Rothschild and Emile-Roux hospitals
Key inclusion criteria (3 listed)
- Patient ≥70 years old
- Hospitalized in SSR for less than 7 days
- No patient opposition
Key exclusion criteria (6 listed)
- patient with a pacemaker
- lake of nutritional assessment on admission
- lake of assessment of autonomy at admission
- Patient under guardianship or curatorship
- Patient participating in another clinical research
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
The prognosis value of variation of weight on mortality
Time frame: 3 months
Determination of variation of weight between D0 and D21 after inclusion
Mortality rate
Time frame: 3 months
Monitoring of survival at 3 months after inclusion
5 secondary outcomes
The pprognosis value of variation of weight on unscheduled readmission in SSR
Time frame: Between D0 and D21
Unscheduled readmission in SSR
Time frame: during 15 days after the end of hospitalization
Lean mass pronostic value
Time frame: 3 months after the inclusion
In fat mass pronostic value
Time frame: 3 months after the inclusion
fat / lean mass ratio
Time frame: 3 months after the inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
Related trials for Body Weight Changes
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
RecruitingObservational study
Two-Year Weight Loss With GLP-1 Medications Compared With Sleeve Gastrectomy in Adults With Obesity
Obesity & Overweight
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.
Christine FORASASSI, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
An observational study of Body Weight Changes, run by Assistance Publique - Hôpitaux de Paris.
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 3 inclusion and 6 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 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Christine FORASASSI, MD (01 40 19 34 14, christine.forasassi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prognosis value of variation of weight on mortality (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 9 Jul 2020.