Bariatric Surgery in Children. (BASIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2011 by Maastricht University Medical Center
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01172899
First received: July 22, 2010
Last updated: October 19, 2011
Last verified: October 2011
  Purpose

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 12 - 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.


Condition Intervention Phase
Obesity, Morbid
Procedure: laparoscopic adjustable gastric band
Behavioral: Combined life style interventions
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The BASIC Trial. Morbid Obesity in Children and Adolescents: a Prospective Randomised Trial of Conservative Treatment Versus Surgery

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Weight loss, excess weight loss and loss of excess BMI.

  • Weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Weight loss, excess weight loss and loss of excess BMI.

  • Weight [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Weight loss, excess weight loss and loss of excess BMI.

  • Weight [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Weight loss, excess weight loss and loss of excess BMI.


Secondary Outcome Measures:
  • Body composition [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fatpercentage will be assessed.

  • Pubertal development [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Follow-up of hormonal status and Tanner stages.

  • Metabolic and endocrine changes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Inflammatory status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measurement of serum inflammatory markers.

  • Cardiovascular abnormalities [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Non-alcoholic fatty liver disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Next to an ultrasound of the liver, serum levels of ALT, AST, ALP and GGT are measured. CCL-2 is used as a surragate marker to assess liver disease.

  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Behaviour changes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measuring impulsivity and positive reward dominance with a computer task.

  • Operative complications [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]
    Early and late complications are being monitored

  • Effects on sleep architecture [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Brain development [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Body composition [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fatpercentage will be assessed.

  • Body composition [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fatpercentage will be assessed.

  • Pubertal development [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Follow-up of hormonal status and Tanner stages.

  • Pubertal development [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Follow-up of hormonal status and Tanner stages.

  • Pubertal development [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    Follow-up of hormonal status and Tanner stages.

  • Metabolic and endocrine changes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Metabolic and endocrine changes [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Metabolic and endocrine changes [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Inflammatory status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measurement of serum inflammatory markers.

  • Inflammatory status [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Measurement of serum inflammatory markers.

  • Inflammatory status [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Measurement of serum inflammatory markers.

  • Cardiovascular abnormalities [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cardiovascular abnormalities [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Cardiovascular abnormalities [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Non-alcoholic fatty liver disease [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Next to an ultrasound of the liver, serum levels of ALT, AST, ALP and GGT are measured. CCL-2 is used as a surragate marker to assess liver disease.

  • Non-alcoholic fatty liver disease [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Next to an ultrasound of the liver, serum levels of ALT, AST, ALP and GGT are measured. CCL-2 is used as a surragate marker to assess liver disease.

  • Non-alcoholic fatty liver disease [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Next to an ultrasound of the liver, serum levels of ALT, AST, ALP and GGT are measured. CCL-2 is used as a surragate marker to assess liver disease.

  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Effects on sleep architecture [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Effects on sleep architecture [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Effects on sleep architecture [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Behaviour changes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measuring impulsivity and positive reward dominance with a computer task.

  • Behaviour changes [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Measuring impulsivity and positive reward dominance with a computer task.

  • Behaviour changes [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Measuring impulsivity and positive reward dominance with a computer task.

  • Brain development [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Brain development [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.

  • Brain development [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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.

  • Physical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assessment of physical activity using a questionnaire and an accelerometer.

  • Physical activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assessment of physical activity using a questionnaire and an accelerometer.

  • Physical activity [ Time Frame: 24 ] [ Designated as safety issue: No ]
    Assessment of physical activity using a questionnaire and an accelerometer.

  • Physical activity [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Assessment of physical activity using a questionnaire and an accelerometer.

  • Behavior towards food [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.

  • Behavior towards food [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.

  • Behavior towards food [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.

  • Behavior towards food [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.


Estimated Enrollment: 60
Study Start Date: July 2010
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laparoscopic adjustable gastric band Procedure: laparoscopic adjustable gastric band
Laparoscopic gastric band placement. Combined lifestyle interventions will continue after surgery.
Behavioral: Combined life style interventions
Control group will receive standard therapy consisting of combined lifestyle interventions.
Active Comparator: Control group Behavioral: Combined life style interventions
Control group will receive standard therapy consisting of combined lifestyle interventions.

  Eligibility

Ages Eligible for Study:   12 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 12 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172899

Contacts
Contact: Givan F Paulus, PhD student +31620727692 g.paulus@mumc.nl
Contact: LWE van Heurn, Professor +31433877477 e.van.heurn@mumc.nl

Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands, 6202ZA
Contact: Givan F Paulus, PhD student    +31433872207    g.paulus@mumc.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: LWE van Heurn, Professor Maastricht University Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01172899     History of Changes
Other Study ID Numbers: NL26279.068.09
Study First Received: July 22, 2010
Last Updated: October 19, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Bariatric Surgery
Adolescent

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014