NCT01172899

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2010

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

11 years

First QC Date

July 22, 2010

Last Update Submit

August 25, 2021

Conditions

Obesity, Morbid

Keywords

Bariatric SurgeryAdolescent

Outcome Measures

Primary Outcomes (4)

  • Weight

    Weight loss, excess weight loss and loss of excess BMI.

    6 months

  • Weight

    Weight loss, excess weight loss and loss of excess BMI.

    12 months

  • Weight

    Weight loss, excess weight loss and loss of excess BMI.

    24 months

  • Weight

    Weight loss, excess weight loss and loss of excess BMI.

    36 months

Secondary Outcomes (48)

  • Body composition

    12 months

  • Pubertal development

    6 months

  • Metabolic and endocrine changes

    6 months

  • Inflammatory status

    6 months

  • Cardiovascular abnormalities

    6 months

  • +43 more secondary outcomes

Study Arms (2)

Laparoscopic adjustable gastric band

EXPERIMENTAL
Procedure: laparoscopic adjustable gastric bandBehavioral: Combined life style interventions

Control group

ACTIVE COMPARATOR
Behavioral: Combined life style interventions

Interventions

laparoscopic adjustable gastric bandPROCEDURE

Laparoscopic gastric band placement. Combined lifestyle interventions will continue after surgery.

Laparoscopic adjustable gastric band
Combined life style interventionsBEHAVIORAL

Control group will receive standard therapy consisting of combined lifestyle interventions.

Control groupLaparoscopic adjustable gastric band

Eligibility Criteria

Age14 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6202ZA, Netherlands

Location

Related Publications (2)

  • Roebroek YGM, Paulus GF, Talib A, van Mil EGAH, Vreugdenhil ACE, Winkens B, Stehouwer CDA, Greve JM, Bouvy ND, van Heurn LWE. Weight Loss and Glycemic Control After Bariatric Surgery in Adolescents With Severe Obesity: A Randomized Controlled Trial. J Adolesc Health. 2024 Mar;74(3):597-604. doi: 10.1016/j.jadohealth.2023.10.024. Epub 2023 Dec 9.

    PMID: 38069930DERIVED

  • Roebroek YGM, Paulus GF, van Mil EGAH, Vreugdenhil ACE, Winkens B, Nederkoorn C, Stehouwer CDA, Greve JWM, Bouvy ND, van Heurn LWE. Bariatric surgery in adolescents: a prospective randomized controlled trial comparing laparoscopic gastric banding to combined lifestyle interventions in adolescents with severe obesity (BASIC trial). BMC Pediatr. 2019 Jan 28;19(1):34. doi: 10.1186/s12887-019-1395-9.

    PMID: 30691442DERIVED

Related Links

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • LWE van Heurn, Professor

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

  • Yvonne Roebroek, PhD Student

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

  • Givan F Paulus, PhD Student

    Spaarne Gasthuis, Haarlem

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2010

First Posted

July 30, 2010

Study Start

December 1, 2011

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

August 26, 2021

Record last verified: 2021-08

Locations

NL(1)