ObesityPhase 4CHADONCT01700738
Evaluation of the Effects of Laying Early a Gastric Band on the Prevention of Morbid Obesity Randomized Checked Against Standard Management of Obesity in This Population.
A Phase 4 study testing gastric ring surgery and nutritional help in people with Obesity, run by University Hospital, Angers at 6 sites in France.
Trial summary
MAIN OBJECTIVE To compare the effects of the placement of an adjustable gastric band with "conventional" treatment of obesity. SECONDARY OBJECTIVES Compare the effects of the placement of a gastric band with "conventional" treatment of obesity on quality of life, body composition and parameters of the metabolic… Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Obesity
- What is being tested?
- gastric ring surgery and nutritional help
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesFrance
- Study dates
- Nov 2012to Nov 2015
- Phase
- Phase 4
- 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 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescents 12 to 16 years and with BMI and weight gain according to sex and age is greater than IMCZ-score > 4 DP> 8 kg
- Obesity "common" non-syndromic.
- Medical decision of surgical placement of laparoscopic gastric banding.
- Adolescent and family who understand and accept the need for medical and surgical follow long term.
- Adolescent and family who fully understood the oral and written information explaining the study and the need for prolonged follow-up.
- Obtention of oral and written consent of the adolescent and the parents.
- Parents and adolescents affiliated with the social security system.
Who cannot join
- Intellectual Deficit.
- psychiatrics contraindication of surgical placement of laparoscopic gastric banding.
- Obesity with severe binge eating.
- Pregnancy or wishes of pregnancy in the following year.
- Non accession adolescent and / or family in the process of medical care before inclusion.
- Predictable post surgical monitoring difficulties.
Show all 10Show fewer
- Suspicion of physical abuse, verbal or negligence / deficiency in care of the family.
- Participation in a clinical study evaluating a treatment during the 2 years of the study.
- Anesthetic contre indication for placement of a gastric laparoscopic.
- IMC> 50 kg/m2 the day of inclusion.
Trial locations and contacts
6 sites in 1 country.
REGIS COUTANT contact
6 sites in 1 country
France6 sites
University Hospital of Angers
Angers, France, 49000
REGIS COUTANT
FRANCOISE SCHMITT
University Hospital of Caen
Caen, 14033
DOMINIQUE BOUGLE, 0231515161
DOMINIQUE BOUGLE
University hospital Bicêtre
Le Kremlin-Bicêtre, 94275
PIERRE BOUGNIERES, 0145217832
PIERRE BOUGNIERE
University Hospital of Lille
Lille, 59037
IVA GUEORGUIEVA, 0320446885
IVA GUEORGUIEVA
University Hospital of Necker
Paris, 75743
OLIVIER GOULET, 0144492501
OLIVIER GOULET
University Hospital of Toulouse
Toulouse, 31059
MAITHE TAUBER, 0534558555
MAITHE TAUBER
About this study
Official title: Evaluation of the Effects of Laying Early (Between 12 and 16) a Gastric Band on the Prevention of Morbid Obesity in Late Adolescence. Randomized Checked Against Standard Management of Obesity in This Population.
MAIN OBJECTIVE To compare the effects of the placement of an adjustable gastric band with "conventional" treatment of obesity.
SECONDARY OBJECTIVES
Read more
- Compare the effects of the placement of a gastric band with "conventional" treatment of obesity on quality of life, body composition and parameters of the metabolic syndrome.
- Identify predictors of "good answer to the ring" to determine the best future indications.
- Study of the gastric tolerance.
INCLUSION CRITERIA
- Adolescents 12 to 16 years and with BMI and weight gain according to sex and age is greater than IMCZ-score > 4 DP> 8 kg
- Obesity "common" non-syndromic.
- Medical decision of surgical placement of laparoscopic gastric banding.
- Adolescent and family who understand and accept the need for medical and surgical follow long term.
- Adolescent and family who fully understood the oral and written information explaining the study and the need for prolonged follow-up.
- Obtention of oral and written consent of the adolescent and the parents.
- Parents and adolescents affiliated with the social security system.
NONINCLUSION CRITERIA
- Intellectual Deficit.
- psychiatrics contraindication of surgical placement of laparoscopic gastric banding.
- Obesity with severe binge eating.
- Pregnancy or wishes of pregnancy in the following year.
- Non accession adolescent and / or family in the process of medical care before inclusion.
- Predictable post surgical monitoring difficulties.
- Suspicion of physical abuse, verbal or negligence / deficiency in care of the family.
- Participation in a clinical study evaluating a treatment during the 2 years of the study.
EXCLUSION CRITERIA
- Anesthetic contre indication for placement of a gastric laparoscopic.
- IMC> 50 kg/m2 the day of inclusion.
STRATEGIES / PROCEDURES During a routine visit, the study will be presented to the patient and his family. Patients will then be enrolled and randomized. Patients in group A (surgery group) will follow the usual multidisciplinary bariatric surgery in adolescents. Patients in group B start conventional monitoring dietary medical and physical. For both groups follow-up visits will occur every 3 months for 2 years.
- Conditions
- Obesity
- Being tested
- gastric ring surgery, nutritional help
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric ring surgeryProcedure or surgery
nutritional helpOther
| Study group | Role | What they receive |
|---|---|---|
| gastric ring surgery | Experimental | in this group a gastric ring will be put by surgery. Receives: Procedure: gastric ring surgery |
| nutritional help | Active comparator | the usual treatment of obesity in France with nutritional care will be dispensed for this arm Receives: Other: nutritional help |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMIZ-score evolution in 2 years.
Measured: 2 years
Secondary outcomes (9)
Evolution of quality of life scales
Measured: 1, 2, 5 and 10 years
Evaluation of des alimentary attitudinal troubles and psychiatrical troubles
Measured: 1 year
Evolution of BMIZ-score
Measured: 1, 5 and 10 years
Evolution of round-waist
Measured: 1, 2, 5 and 10 years
Evolution of bodily composition.
Measured: 1, 2, 5 and 10 years
Evolution of metabolic syndrome parameters.
Measured: 1, 2, 5 and 10 years
Evolution of respiratory parameters: polysomnography
Measured: 2 years
Determination of success factors of the ring.
Measured: 2 years
Study of tolerance of the gastric ring.
Measured: 1, 2, 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
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 ObesityStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- REGIS COUTANT, Principal investigator, UNIVERSITY HOSPITAL OF ANGERS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700738
- Sponsor's protocol ID
- 2012 - A00555-38
- Acronym
- CHADO
- Status last verified
- Oct 2012
- First submitted
- 2 Oct 2012
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Pourcher G, De Filippo G, Ferretti S, Piquard C, Dagher I, Bougneres P. Short-term results of single-port sleeve gastrectomy in adolescents with severe obesity. Surg Obes Relat Dis. 2015 Jan-Feb;11(1):65-9. doi: 10.1016/j.soard.2014.05.029. Epub 2014 Jun 3.
PubMed 25393047
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Laying Early (Between 12 and 16) a Gastric Band on the Prevention of Morbid Obesity in Late Adolescence. Randomized Checked Against Standard Management of Obesity in This Population.
- ClinicalTrials.gov ID
- NCT01700738
- Acronym / sponsor ID
- CHADO / 2012 - A00555-38
- Conditions
- Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Nov 2012
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 4 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.
MAIN OBJECTIVE To compare the effects of the placement of an adjustable gastric band with "conventional" treatment of obesity.
SECONDARY OBJECTIVES
- Compare the effects of the placement of a gastric band with "conventional" treatment of obesity on quality of life, body composition and parameters of the metabolic syndrome.
- Identify predictors of "good answer to the ring" to determine the best future indications.
- Study of the gastric tolerance.
INCLUSION CRITERIA
- Adolescents 12 to 16 years and with BMI and weight gain according to sex and age is greater than IMCZ-score > 4 DP> 8 kg
- Obesity "common" non-syndromic.
- Medical decision of surgical placement of laparoscopic gastric banding.
- Adolescent and family who understand and accept the need for medical and surgical follow long term.
- Adolescent and family who fully understood the oral and written information explaining the study and the need for prolonged follow-up.
- Obtention of oral and written consent of the adolescent and the parents.
- Parents and adolescents affiliated with the social security system.
NONINCLUSION CRITERIA
- Intellectual Deficit.
- psychiatrics contraindication of surgical placement of laparoscopic gastric banding.
- Obesity with severe binge eating.
- Pregnancy or wishes of pregnancy in the following year.
- Non accession adolescent and / or family in the process of medical care before inclusion.
- Predictable post surgical monitoring difficulties.
- Suspicion of physical abuse, verbal or negligence / deficiency in care of the family.
- Participation in a clinical study evaluating a treatment during the 2 years of the study.
EXCLUSION CRITERIA
- Anesthetic contre indication for placement of a gastric laparoscopic.
- IMC> 50 kg/m2 the day of inclusion.
STRATEGIES / PROCEDURES During a routine visit, the study will be presented to the patient and his family. Patients will then be enrolled and randomized. Patients in group A (surgery group) will follow the usual multidisciplinary bariatric surgery in adolescents. Patients in group B start conventional monitoring dietary medical and physical. For both groups follow-up visits will occur every 3 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gastric ring surgery | Experimental | Procedure: gastric ring surgeryin this group a gastric ring will be put by surgery. |
| nutritional help | Active comparator | Other: nutritional helpthe usual treatment of obesity in France with nutritional care will be dispensed for this arm |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Adolescents 12 to 16 years and with BMI and weight gain according to sex and age is greater than IMCZ-score > 4 DP> 8 kg
- Obesity "common" non-syndromic.
- Medical decision of surgical placement of laparoscopic gastric banding.
- Adolescent and family who understand and accept the need for medical and surgical follow long term.
- Adolescent and family who fully understood the oral and written information explaining the study and the need for prolonged follow-up.
Key exclusion criteria (10 listed)
- Intellectual Deficit.
- psychiatrics contraindication of surgical placement of laparoscopic gastric banding.
- Obesity with severe binge eating.
- Pregnancy or wishes of pregnancy in the following year.
- Non accession adolescent and / or family in the process of medical care before inclusion.
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 |
|---|---|---|
| gastric ring surgery | Procedure or surgery | gastric ring surgery |
| nutritional help | Other | nutritional help |
Primary outcome
BMIZ-score evolution in 2 years.
Time frame: 2 years
9 secondary outcomes
Evolution of quality of life scales
Time frame: 1, 2, 5 and 10 years
Evaluation of des alimentary attitudinal troubles and psychiatrical troubles
Time frame: 1 year
Evolution of BMIZ-score
Time frame: 1, 5 and 10 years
Evolution of round-waist
Time frame: 1, 2, 5 and 10 years
Evolution of bodily composition.
Time frame: 1, 2, 5 and 10 years
Evolution of metabolic syndrome parameters.
Time frame: 1, 2, 5 and 10 years
Evolution of respiratory parameters: polysomnography
Time frame: 2 years
Determination of success factors of the ring.
Time frame: 2 years
Study of tolerance of the gastric ring.
Time frame: 1, 2, 5 and 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
- Derived from this study: PubMed 25393047Pourcher G, De Filippo G, Ferretti S, Piquard C, Dagher I, Bougneres P. Short-term results of single-port sleeve gastrectomy in adolescents with severe obesity. Surg Obes Relat Dis. 2015 Jan-Feb;11(1):65-9. doi: 10.1016/j.soard.2014.05.029. Epub 2014 Jun 3.
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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.
REGIS COUTANT contact
REGIS COUTANT principal investigator
UNIVERSITY HOSPITAL OF ANGERS
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing gastric ring surgery and nutritional help in people with Obesity, run by University Hospital, Angers at 6 sites 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 7 inclusion and 10 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 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 REGIS COUTANT (recoutant@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMIZ-score evolution in 2 years. (time frame: 2 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 NCT01700738, 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 4 Oct 2012.