Obesity, MorbidBAREVALNCT02310178
Obesity Cohort : Medical Follow-up of Severe or Morbid Obese Patients Undergoing Bariatric Surgery
A study testing Bariatric surgery in people with Obesity, Morbid and Bariatric Surgery Candidate, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The aim of this cohort is to evaluate the follow-up of morbidly obese patients treated by several types of bariatric procedures. In addition, this study could lead to the development of clinical trials on assessment of the bariatric surgery impact. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Obesity, Morbid, Bariatric Surgery Candidate
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2012to Dec 2028
- Phase
- Interventional
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Only be considered in patients operated and followed at CHU Montpellier with bariatric surgery
- Patients treated by bariatric surgery on CHU Montpellier
- Agreed to participate to the study by signing an informed consent
- Eligible to health insurance
Who cannot join
- Unable to follow the patient in the long term (foreign patients, surgical use ...)
- Inability to follow in the long run
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU - Hôpital Saint Eloi
Montpellier, 34295
David NOCCA, PUPH, 0467337731 ext. +33, d-nocca@chu-montpellier.fr
About this study
The aim of this cohort is to evaluate the follow-up of morbidly obese patients treated by several types of bariatric procedures. In addition, this study could lead to the development of clinical trials on assessment of the bariatric surgery impact.
Read the detailed description
The main objective is to prospectively evaluate long-term efficiency of bariatric surgery in terms of weight loss. Moreover, this cohort wants to assess the long-term effectiveness of bariatric surgery on comorbidities and quality of life, the medical and economic impact of bariatric surgery (before-after comparison using data from health insurance), estimates the incidence of mortality and morbidity of bariatric surgery and to finish describe the evolution of patients in case of new-surgery. From a methodological point of view, the Obesity cohort is a prospective cohort study, single-center, open, with aftercare performed during life of patients. The number of inclusions is to 1500 patients. After surgery , patients will be followed at least 4 visits the first year and at least 2 visits a year then. The recommendations of the french health ministry (HAS), the frequency of visits may be increased according to the patient's progress. Follow-up visits of patients after bariatric surgery will be performed by physicians or surgeons of the multidisciplinary team responsible for the care of the patient (digestive and reconstructive surgery, anesthesiology, endocrinology, medical imaging, gastroenterology, immunology and physiology) . It will be insured for life, obesity is a chronic disease and because of the risk of late complications.
- Conditions
- Obesity, Morbid, Bariatric Surgery Candidate
- Being tested
- Bariatric surgery
- Keywords
- weight loss, sleeve gastrectomy, gastric bypass, gastric banding, bariatric procedures, cohort, morbid obesity, medical and economical impact, severe obesity
- Medical subject headings
- Obesity, Morbid, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
all of the current bariatric surgeries are allowed in this prospective cohort study
| Study group | Role | What they receive |
|---|---|---|
| Group/Cohort | Other | all of the current bariatric surgeries are allowed in this prospective cohort study Receives: Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the long-term efficiency of bariatric surgery on weight loss
Assessment of weight loss
Measured: Change from intervention to 5 years
Secondary outcomes (9)
Assessment of the long-term efficiency of bariatric surgery on diabetes
Assessment of blood glucose, HbA1c and diabetes medications
Measured: Change from intervention to 5 years
Assessment of the long-term efficiency of bariatric surgery on High Blood Pressure
Assessment of Systolic Blood Pressure and blood pressure medications
Measured: Change from intervention to 5 years
Assessment of the long-term efficiency of bariatric surgery on dyslipidemia
Assessment of cholesterolemia and triglyceridemia and dyslipidemia medications
Measured: Change from intervention to 5 years
Assessment of the long-term efficiency of bariatric surgery on rheumatism
Assessment of rheumatism medications
Measured: Change from intervention to 5 years
Assessment of the long-term efficiency of bariatric surgery on respiratory pathologies
Assessment of respiratory pathologies medications
Measured: Change from intervention to 5 years
Assessment of the long-term efficiency of bariatric surgery on sleep apnea syndrome
polysomnography tests
Measured: Change from intervention to 3 months
Assessment of the long-term efficiency of bariatric surgery on quality of life
Assessment of quality of life questionnaires (SF36 and BAROS)
Measured: Change from intervention to 5 years
Assessment of medico-economic impact of bariatric surgery
Comparison of health insurance data
Measured: Change from intervention to 5 years
Assessment of mortality of bariatric surgery
Assessment of the date of death
Measured: Change from intervention to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study start21 May 2012
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310178
- Sponsor's protocol ID
- UF 8855
- Acronym
- BAREVAL
- Status last verified
- Jun 2026
- First submitted
- 28 Oct 2014
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Saux P, Bauvin P, Raverdy V, Teigny J, Verkindt H, Soumphonphakdy T, Debert M, Jacobs A, Jacobs D, Monpellier V, Lee PC, Lim CH, Andersson-Assarsson JC, Carlsson L, Svensson PA, Galtier F, Dezfoulian G, Moldovanu M, Andrieux S, Couster J, Lepage M, Lembo E, Verrastro O, Robert M, Salminen P, Mingrone G, Peterli R, Cohen RV, Zerrweck C, Nocca D, Le Roux CW, Caiazzo R, Preux P, Pattou F. Development and validation of an interpretable machine learning-based calculator for predicting 5-year weight trajectories after bariatric surgery: a multinational retrospective cohort SOPHIA study. Lancet Digit Health. 2023 Oct;5(10):e692-e702. doi: 10.1016/S2589-7500(23)00135-8. Epub 2023 Aug 29.
PubMed 37652841Nocca D, Galtier F, Taleb S, Picot MC, Jaussent A, Silvestri M, Lefebvre P, de Jong A, Gautier T, Loureiro M, Nedelcu M. Peri-operative Morbidity of Nissen Sleeve Gastrectomy: Prospective Evaluation of a Cohort of 365 Patients, Beyond the Learning Curve. Obes Surg. 2022 Jul;32(7):1-7. doi: 10.1007/s11695-022-06066-0. Epub 2022 May 7.
PubMed 35524904