- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Limburg
-
Maastricht, Limburg, Nederland, 6202ZA
- Maastricht University Medical Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: Controlegroep
|
Control group will receive standard therapy consisting of combined lifestyle interventions.
|
Experimenteel: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Weight
Tijdsspanne: 6 months
|
Weight loss, excess weight loss and loss of excess BMI.
|
6 months
|
Weight
Tijdsspanne: 12 months
|
Weight loss, excess weight loss and loss of excess BMI.
|
12 months
|
Weight
Tijdsspanne: 24 months
|
Weight loss, excess weight loss and loss of excess BMI.
|
24 months
|
Weight
Tijdsspanne: 36 months
|
Weight loss, excess weight loss and loss of excess BMI.
|
36 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Body composition
Tijdsspanne: 12 months
|
Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed.
|
12 months
|
Pubertal development
Tijdsspanne: 6 months
|
Follow-up of hormonal status and Tanner stages.
|
6 months
|
Metabolic and endocrine changes
Tijdsspanne: 6 months
|
6 months
|
|
Inflammatory status
Tijdsspanne: 6 months
|
Measurement of serum inflammatory markers.
|
6 months
|
Cardiovascular abnormalities
Tijdsspanne: 6 months
|
6 months
|
|
Non-alcoholic fatty liver disease
Tijdsspanne: 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
Tijdsspanne: 6 months
|
6 months
|
|
Behaviour changes
Tijdsspanne: 6 months
|
Measuring impulsivity and positive reward dominance with a computer task.
|
6 months
|
Operative complications
Tijdsspanne: up to 36 months
|
Early and late complications are being monitored
|
up to 36 months
|
Effects on sleep architecture
Tijdsspanne: 6 months
|
6 months
|
|
Brain development
Tijdsspanne: 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
Tijdsspanne: 24 months
|
Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed.
|
24 months
|
Body composition
Tijdsspanne: 36 months
|
Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed.
|
36 months
|
Pubertal development
Tijdsspanne: 12 months
|
Follow-up of hormonal status and Tanner stages.
|
12 months
|
Pubertal development
Tijdsspanne: 24 months
|
Follow-up of hormonal status and Tanner stages.
|
24 months
|
Pubertal development
Tijdsspanne: 36 months
|
Follow-up of hormonal status and Tanner stages.
|
36 months
|
Metabolic and endocrine changes
Tijdsspanne: 12 months
|
12 months
|
|
Metabolic and endocrine changes
Tijdsspanne: 24 months
|
24 months
|
|
Metabolic and endocrine changes
Tijdsspanne: 36 months
|
36 months
|
|
Inflammatory status
Tijdsspanne: 12 months
|
Measurement of serum inflammatory markers.
|
12 months
|
Inflammatory status
Tijdsspanne: 24 months
|
Measurement of serum inflammatory markers.
|
24 months
|
Inflammatory status
Tijdsspanne: 36 months
|
Measurement of serum inflammatory markers.
|
36 months
|
Cardiovascular abnormalities
Tijdsspanne: 12 months
|
12 months
|
|
Cardiovascular abnormalities
Tijdsspanne: 24 months
|
24 months
|
|
Cardiovascular abnormalities
Tijdsspanne: 36 months
|
36 months
|
|
Non-alcoholic fatty liver disease
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 12 months
|
12 months
|
|
Quality of life changes
Tijdsspanne: 24 months
|
24 months
|
|
Quality of life changes
Tijdsspanne: 36 months
|
36 months
|
|
Effects on sleep architecture
Tijdsspanne: 12 months
|
12 months
|
|
Effects on sleep architecture
Tijdsspanne: 24 months
|
24 months
|
|
Effects on sleep architecture
Tijdsspanne: 36 months
|
36 months
|
|
Behaviour changes
Tijdsspanne: 12 months
|
Measuring impulsivity and positive reward dominance with a computer task.
|
12 months
|
Behaviour changes
Tijdsspanne: 24 months
|
Measuring impulsivity and positive reward dominance with a computer task.
|
24 months
|
Behaviour changes
Tijdsspanne: 36 months
|
Measuring impulsivity and positive reward dominance with a computer task.
|
36 months
|
Brain development
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 6 months
|
Assessment of physical activity using a questionnaire and an accelerometer.
|
6 months
|
Physical activity
Tijdsspanne: 12 months
|
Assessment of physical activity using a questionnaire and an accelerometer.
|
12 months
|
Physical activity
Tijdsspanne: 24
|
Assessment of physical activity using a questionnaire and an accelerometer.
|
24
|
Physical activity
Tijdsspanne: 36 months
|
Assessment of physical activity using a questionnaire and an accelerometer.
|
36 months
|
Behavior towards food
Tijdsspanne: 6 months
|
Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.
|
6 months
|
Behavior towards food
Tijdsspanne: 12 months
|
Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.
|
12 months
|
Behavior towards food
Tijdsspanne: 24 months
|
Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.
|
24 months
|
Behavior towards food
Tijdsspanne: 36 months
|
Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.
|
36 months
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: LWE van Heurn, Professor, Maastricht University Medical Center
- Hoofdonderzoeker: Yvonne Roebroek, PhD Student, Maastricht University Medical Center
- Hoofdonderzoeker: Givan F Paulus, PhD Student, Spaarne Gasthuis, Haarlem
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NL26279.068.09
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Obesitas, morbide
-
Liverpool University Hospitals NHS Foundation TrustImperial College LondonIngetrokkenOBESITAS, MORBID | BARIATRISCHE CHIRURGIE KANDIDAATVerenigd Koninkrijk
Klinische onderzoeken op laparoscopic adjustable gastric band
-
University of California, IrvineVoltooidMorbide obesitasVerenigde Staten