Adolescents Bariatric Surgery Cohort Survey
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-20
SponsorUniversity Hospital, Angers
About this trial
Obesity affects 3%-4% of the pediatric population and leads to cardiac mortality during adult life. Bariatric surgery is the best treatment for weight loss and preventing obesity associated comorbidities in adults, but its applications and safety are yet to be defined for adolescents.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 14-20 years of age and asking for bariatric surgery
BMI >= 40 Kg.m-2 or >= 35 Kg.m-2 with major obesity-related comorbidities (hypertension, diabetes, sleep apnea, etc...)
Disqualifiers
An unstable psychiatric disorder
Bariatric surgery anesthesic contraindications
Having not completed a minimum of six months of the pre operative program
Lack of consent from the patient or the patient's relatives.
Trial population
Pediatric patients treated in our hospital for morbid obesity (BMI \>= 35 Kg.M-2) through different programs with lifestyle and nutritional interventions and, for those who requested it, the possibility of bariatric surgery.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Laparoscopic adjustable gastric banding
Procedure/SurgeryWeight-loss surgery, with the use of gastric banding
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Change of weight parameters at 2 years compared to preoperative baseline
Evaluation of weight loss by weight (Kg), body mass index (BMI, Kg.m-2) and excess body weight (EBWL, %) changes
Time frame
2 yearsSecondary outcomes
1
Changes of insulin resistance at 2 years
Evaluation of insulin resistance by measure of the HOMA index
Time frame
2 years2
Evaluation of dyslipidemia
Evaluation of lipid profile (cholesterol, triglycerides)
Time frame
2 years3
Evaluation of liver steatosis
Evaluation of liver steatosis and NAFLD on US exam and liver elastometry
Time frame
2 years4
Resolution of comorbidities associated with obesity
Clinical evaluation of the presence/absence of hypertension, sleep apnea, orthopedic disorders and polycystic ovary at two years, compared to Baseline characteristics
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov