Bariatric Surgery CandidateMMS-CBNCT03558360
Preoperative Dry Lean Body Mass as a Prognostic Factor for Excess Weight Loss After Bariatric Surgery.
An observational study of Bariatric Surgery Candidate, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial summary
Bariatric surgery is currently the only method that has proven long-term effectiveness in obesity. Although the benefit of physical activity on weight loss has been demonstrated, no correlation has ever been reported between preoperative lean body mass and postoperative weight loss. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Impedance measurement
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2018to 1 Sep 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting (or having presented since 2014) an obesity with a bariatric surgery project and followed by endocrinologist doctors.
Who may be able to join
- BMI ≥ 40 or BMI ≥ 35 kg/m2 and a complication that can be improved after bariatric surgery: cardiovascular disease including hypertension, severe metabolic disorder including type 2 diabetes, sleep apnea syndrome or other severe respiratory disorder, hepatic steatosis, disabling osteoarticular disease.
- Patient requiring bariatric surgery (sleeve-gastrectomy or gastric bypass)
- Patient who has agreed to participate in the study
- Patient with social security coverage.
Who cannot join
- Patient with a contraindication to bariatric surgery (cognitive or psychological disorders, severe eating disorders, addiction to alcohol or psychoactive substances, contraindication to general anaesthesia, multiple history of digestive surgery, high risk of undernutrition (progressive cancer, chronic inflammatory bowel disease, cirrhosis, severe renal insufficiency...)
- Pregnant or lactating women
- Minor patient
- Major patient under tutorship, curatorship, or deprived of liberty
- Patient unable to understand protocol and / or give express consent
- Patient not affiliated with a social security system or beneficiary of such a scheme
- Patient participating in an intervention-type clinical research protocol likely to modify the evaluations of this protocol
- adults under the protection of justice
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Departemental Vendée
La Roche-sur-Yon, 85925
François ETCHEVERRIGARAY, francois.etcheverrigaray@chd-vendee.fr
Barbara FEIGEL-GUILLER, MD
About this study
Bariatric surgery is currently the only method that has proven long-term effectiveness in obesity. Although the benefit of physical activity on weight loss has been demonstrated, no correlation has ever been reported between preoperative lean body mass and postoperative weight loss. Dry lean mass is probably an essential prognostic factor for the effectiveness of bariatric surgery.
The main objective of this study is to define a preoperative dry lean body mass threshold as a worst prognostic factor for weight loss one year after bariatric surgery.
The management of patients included in this study was modelled on the management usually offered to patients followed for the same pathology in the diabeto-endocrinology department. There are no study-specific examinations that are not part of current practice.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Impedance measurement
- Keywords
- lean body mass, bariatric surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impedance measurementDiagnostic test
Measurement of dry lean body mass berfore bariatric surgery by impedance measurement.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surger | Bariatric surgery and impedance measurement Receives: Diagnostic Test: Impedance measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of dry lean mass in pre-operative by impedance measurement
Excess weight loss at M12: ideal weight is defined in relation to height for a BMI of 25.0 kg/m2. Excess weight is the difference between the observed weight and the ideal weight. Excess weight loss is the ratio of weight loss to excess weight.
Measured: 12 months after bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start15 Oct 2018
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara FEIGEL-GUILLER, MD, Study director, Centre Hospitalier Départemental Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558360
- Sponsor's protocol ID
- CHD 048-17
- Acronym
- MMS-CB
- Status last verified
- Dec 2021
- First submitted
- 4 Jun 2018
- Last updated
- 23 Dec 2021
- 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 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Dry Lean Body Mass as a Prognostic Factor for Excess Weight Loss After Bariatric Surgery.
- ClinicalTrials.gov ID
- NCT03558360
- Acronym / sponsor ID
- MMS-CB / CHD 048-17
- Conditions
- Bariatric Surgery Candidate
- Keywords
- lean body mass, bariatric surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 15 Jun 2018 (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.
Bariatric surgery is currently the only method that has proven long-term effectiveness in obesity. Although the benefit of physical activity on weight loss has been demonstrated, no correlation has ever been reported between preoperative lean body mass and postoperative weight loss. Dry lean mass is probably an essential prognostic factor for the effectiveness of bariatric surgery.
The main objective of this study is to define a preoperative dry lean body mass threshold as a worst prognostic factor for weight loss one year after bariatric surgery.
The management of patients included in this study was modelled on the management usually offered to patients followed for the same pathology in the diabeto-endocrinology department. There are no study-specific examinations that are not part of current practice.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric surger | – | Diagnostic Test: Impedance measurementBariatric surgery and impedance measurement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting (or having presented since 2014) an obesity with a bariatric surgery project and followed by endocrinologist doctors.
Key inclusion criteria (4 listed)
- BMI ≥ 40 or BMI ≥ 35 kg/m2 and a complication that can be improved after bariatric surgery: cardiovascular disease including hypertension, severe metabolic disorder including type 2 diabetes, sleep apnea syndrome or other severe respiratory disorder, hepatic steatosis, disabling osteoarticular disease.
- Patient requiring bariatric surgery (sleeve-gastrectomy or gastric bypass)
- Patient who has agreed to participate in the study
- Patient with social security coverage.
Key exclusion criteria (8 listed)
- Patient with a contraindication to bariatric surgery (cognitive or psychological disorders, severe eating disorders, addiction to alcohol or psychoactive substances, contraindication to general anaesthesia, multiple history of digestive surgery, high risk of undernutrition (progressive cancer, chronic inflammatory bowel disease, cirrhosis, severe renal insufficiency...)
- Pregnant or lactating women
- Minor patient
- Major patient under tutorship, curatorship, or deprived of liberty
- Patient unable to understand protocol and / or give express consent
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 |
|---|---|---|
| Impedance measurementMeasurement of dry lean body mass berfore bariatric surgery by impedance measurement. | Diagnostic test | Bariatric surger |
Primary outcome
Measurement of dry lean mass in pre-operative by impedance measurement
Time frame: 12 months after bariatric surgery
Excess weight loss at M12: ideal weight is defined in relation to height for a BMI of 25.0 kg/m2. Excess weight is the difference between the observed weight and the ideal weight. Excess weight loss is the ratio of weight loss to excess weight.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
Related trials for Bariatric Surgery Candidate
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
RecruitingObservational study
Blood Collection Biorepository for Liver Disease Research
Non-Alcoholic Steatohepatitis(NASH), Hepatitis C
Enrolling by invitationObservational study
Dietary Sugar Absorptive Phenotype for Prediction of Weight Loss Outcome
Obese, Healthy
Active, not recruiting
Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids
Opioid Use, Unspecified, Bariatric Surgery Candidate
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.
Barbara FEIGEL-GUILLER, MD study director
Centre Hospitalier Départemental Vendée
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 Bariatric Surgery Candidate, run by Centre Hospitalier Departemental Vendee 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 8 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 23 Dec 2021. 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 François ETCHEVERRIGARAY, PharmD (+33 2 51 44 65 72, francois.etcheverrigaray@chd-vendee.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of dry lean mass in pre-operative by impedance measurement (time frame: 12 months after bariatric surgery). 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 23 Dec 2021.