- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01172899
Bariatric Surgery in Children. (BASIC)
The BASIC Trial. Morbid Obesity in Children and Adolescents: a Prospective Randomised Trial of Conservative Treatment Versus Surgery
Rationale:
In the Western world overweight and obesity is an increasing problem both in adults and in children. In youth, it is associated with early death and a number of co-morbidities including metabolic and endocrine changes, increased inflammatory status, cardiovascular abnormalities, nonalcoholic fatty liver disease, and impaired quality of life.
The standard treatment for morbid obesity in children is by combined life style interventions. However, the medium and long term effects of dietetic interventions, behaviour therapy and medication is relatively poor. In adults bariatric surgery shows good results with up to 30% weight reduction in 3 years. The preliminary results in youth are similar, but surgery in this age group is relatively uncommon. In the Netherlands surgery in this age group is only allowed in clinical trials, until the benefits and risks have been established. (National Health Authorities)
Objective:
To determine if surgery gives a superior weight and body mass index (BMI) reduction than combined life style interventions in adolescents with morbid obesity and to assess its effect on obesity associated co-morbidity.
Study design:
Prospective randomised interventional study.
Study population:
Morbidly obese children, aged 14 - 16 years, with sex and age adjusted BMI >40 kg/m2 or >35 kg/m2 with co-morbidity.
Intervention:
Bariatric surgery by laparoscopic adjustable gastric band (LAGB) or combined life style interventions
Main study parameters/endpoints:
Primary endpoints: weight loss, loss of excess weight, loss of excess BMI. Secondary endpoints: Body composition, pubertal development, metabolic and endocrine changes, inflammatory status, cardiovascular abnormalities, non-alcoholic steatohepatitis, brain development, quality of life, and behaviour changes. The potential complications of surgery are monitored.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Limburg
-
Maastricht, Limburg, Pays-Bas, 6202ZA
- Maastricht University Medical Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Aged 14 to 16
Age and sex adjusted BMI >40 kg/m2 or >35 kg/m2 with associated co-morbidity.
* Associated co-morbidity includes: glucose intolerance, type 2 diabetes, hypertension, pseudotumor cerebri, acanthosis nigricans, obstructive sleep apnoea syndrome, depression, arthropathies, non-alcoholic steatohepatitis and dyslipidemia.
- > 1 year multidisciplinary organized weight reducing attempts with less than 5% weight loss
- Demonstrate decisional capacity
Exclusion Criteria:
- Psychologically not suitable
- Pre-menarche or bone age <15 years in boys
- Obesity associated to other disorders such as hypothyroidism
- Syndromal disorders such as Prader-Willi syndrome
- Severe cardiorespiratory impairment (ASA class 3 or higher)
- Insufficiently fluid in the Dutch language
- Unwillingness to adhere to follow-up programmes
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Groupe de contrôle
|
Control group will receive standard therapy consisting of combined lifestyle interventions.
|
Expérimental: Laparoscopic adjustable gastric band
|
Laparoscopic gastric band placement.
Combined lifestyle interventions will continue after surgery.
Control group will receive standard therapy consisting of combined lifestyle interventions.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Weight
Délai: 6 months
|
Weight loss, excess weight loss and loss of excess BMI.
|
6 months
|
Weight
Délai: 12 months
|
Weight loss, excess weight loss and loss of excess BMI.
|
12 months
|
Weight
Délai: 24 months
|
Weight loss, excess weight loss and loss of excess BMI.
|
24 months
|
Weight
Délai: 36 months
|
Weight loss, excess weight loss and loss of excess BMI.
|
36 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Body composition
Délai: 12 months
|
Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed.
|
12 months
|
Pubertal development
Délai: 6 months
|
Follow-up of hormonal status and Tanner stages.
|
6 months
|
Metabolic and endocrine changes
Délai: 6 months
|
6 months
|
|
Inflammatory status
Délai: 6 months
|
Measurement of serum inflammatory markers.
|
6 months
|
Cardiovascular abnormalities
Délai: 6 months
|
6 months
|
|
Non-alcoholic fatty liver disease
Délai: 6 months
|
Next to an ultrasound of the liver, serum levels of ALT, AST, ALP and GGT are measured.
CCL-2 is used as a surrogate marker to assess liver disease.
|
6 months
|
Quality of life changes
Délai: 6 months
|
6 months
|
|
Behaviour changes
Délai: 6 months
|
Measuring impulsivity and positive reward dominance with a computer task.
|
6 months
|
Operative complications
Délai: up to 36 months
|
Early and late complications are being monitored
|
up to 36 months
|
Effects on sleep architecture
Délai: 6 months
|
6 months
|
|
Brain development
Délai: 6 months
|
If extra sponsorship can be gained, we will use fMRI and MEG in a subgroup to measure blood oxygen level-dependent (BOLD) brain response to food stimuli.
|
6 months
|
Body composition
Délai: 24 months
|
Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed.
|
24 months
|
Body composition
Délai: 36 months
|
Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed.
|
36 months
|
Pubertal development
Délai: 12 months
|
Follow-up of hormonal status and Tanner stages.
|
12 months
|
Pubertal development
Délai: 24 months
|
Follow-up of hormonal status and Tanner stages.
|
24 months
|
Pubertal development
Délai: 36 months
|
Follow-up of hormonal status and Tanner stages.
|
36 months
|
Metabolic and endocrine changes
Délai: 12 months
|
12 months
|
|
Metabolic and endocrine changes
Délai: 24 months
|
24 months
|
|
Metabolic and endocrine changes
Délai: 36 months
|
36 months
|
|
Inflammatory status
Délai: 12 months
|
Measurement of serum inflammatory markers.
|
12 months
|
Inflammatory status
Délai: 24 months
|
Measurement of serum inflammatory markers.
|
24 months
|
Inflammatory status
Délai: 36 months
|
Measurement of serum inflammatory markers.
|
36 months
|
Cardiovascular abnormalities
Délai: 12 months
|
12 months
|
|
Cardiovascular abnormalities
Délai: 24 months
|
24 months
|
|
Cardiovascular abnormalities
Délai: 36 months
|
36 months
|
|
Non-alcoholic fatty liver disease
Délai: 12 months
|
Next to an ultrasound of the liver, serum levels of ALT, AST, ALP and GGT are measured.
CCL-2 is used as a surrogate marker to assess liver disease.
|
12 months
|
Non-alcoholic fatty liver disease
Délai: 24 months
|
Next to an ultrasound of the liver, serum levels of ALT, AST, ALP and GGT are measured.
CCL-2 is used as a surrogate marker to assess liver disease.
|
24 months
|
Non-alcoholic fatty liver disease
Délai: 36 months
|
Next to an ultrasound of the liver, serum levels of ALT, AST, ALP and GGT are measured.
CCL-2 is used as a surrogate marker to assess liver disease.
|
36 months
|
Quality of life changes
Délai: 12 months
|
12 months
|
|
Quality of life changes
Délai: 24 months
|
24 months
|
|
Quality of life changes
Délai: 36 months
|
36 months
|
|
Effects on sleep architecture
Délai: 12 months
|
12 months
|
|
Effects on sleep architecture
Délai: 24 months
|
24 months
|
|
Effects on sleep architecture
Délai: 36 months
|
36 months
|
|
Behaviour changes
Délai: 12 months
|
Measuring impulsivity and positive reward dominance with a computer task.
|
12 months
|
Behaviour changes
Délai: 24 months
|
Measuring impulsivity and positive reward dominance with a computer task.
|
24 months
|
Behaviour changes
Délai: 36 months
|
Measuring impulsivity and positive reward dominance with a computer task.
|
36 months
|
Brain development
Délai: 12 months
|
If extra sponsorship can be gained, we will use fMRI and MEG in a subgroup to measure blood oxygen level-dependent (BOLD) brain response to food stimuli.
|
12 months
|
Brain development
Délai: 24 months
|
If extra sponsorship can be gained, we will use fMRI and MEG in a subgroup to measure blood oxygen level-dependent (BOLD) brain response to food stimuli.
|
24 months
|
Brain development
Délai: 36 months
|
If extra sponsorship can be gained, we will use fMRI and MEG in a subgroup to measure blood oxygen level-dependent (BOLD) brain response to food stimuli.
|
36 months
|
Physical activity
Délai: 6 months
|
Assessment of physical activity using a questionnaire and an accelerometer.
|
6 months
|
Physical activity
Délai: 12 months
|
Assessment of physical activity using a questionnaire and an accelerometer.
|
12 months
|
Physical activity
Délai: 24
|
Assessment of physical activity using a questionnaire and an accelerometer.
|
24
|
Physical activity
Délai: 36 months
|
Assessment of physical activity using a questionnaire and an accelerometer.
|
36 months
|
Behavior towards food
Délai: 6 months
|
Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.
|
6 months
|
Behavior towards food
Délai: 12 months
|
Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.
|
12 months
|
Behavior towards food
Délai: 24 months
|
Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.
|
24 months
|
Behavior towards food
Délai: 36 months
|
Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.
|
36 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: LWE van Heurn, Professor, Maastricht University Medical Center
- Chercheur principal: Yvonne Roebroek, PhD Student, Maastricht University Medical Center
- Chercheur principal: Givan F Paulus, PhD Student, Spaarne Gasthuis, Haarlem
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NL26279.068.09
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