Surgical Intervention for Morbidly Obese Adolescents

Obesity Clinical Trial

Official title:

Surgical Intervention With Laparoscopic Roux-en-Y Gastric Bypass for Morbid Obesity in Adolescence - a Matched Control Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00289705
• Other study ID #: SU523-04
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 9, 2006
• Last updated: February 1, 2017
• Start date: February 2006
• Est. completion date: February 2018

Study information

• Verified date: February 2017
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose is to study whether the positive effects from obesity surgery in adults also can be achieved when adolescent subjects are operated.

Our hypothesis is that the effects concerning weight loss, health improvement and improved quality of life will be as good in adolescents as in adults.

Description:

Severe obesity in the adolescence is a major concern since there is a constant rise in prevalence worldwide. There is a need of effective tools to treat those patients since the natural course with conservative treatment is very pessimistic. I. e. most of the subjects having a BMI >40kg/m2 in the adolescence will remain morbidly obese also in their adult life.

The three largest centres in Sweden treating obese children (Stockholm, Gothenburg and Malmö) will offer patients fulfilling the inclusion criteria to be operated with laparoscopic gastric bypass. If not willing to be operated they could join the study as a control case.

Subjects will be investigated at the baseline concerning physical health status and existence of medical risk factors but also regarding their quality of life, eating habits and physical activity. They will subsequently be follow over a ten year period regarding these variables.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: February 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• BMI >40 kg/m2 or BMI>35 with comorbidity

• Pass psychological evaluation

• Puberty status Tanner 4-5

• At least one year with active conservative treatment that failed

Exclusion Criteria:

• Lack of compliance

• Specific obesity syndrome as Praeder Willis

• Obesity due to brain injury

• Severe general disease

• Specific genetic defect (MC4R, Leptin deficiency)

Related Conditions & MeSH terms

• Diabetes
• Hypertension
• Obesity

Intervention

Procedure:
• Surgery
Laparoscopic Roux-en-Y gastric bypass

Locations

Country	Name	City	State
Sweden	Queen Silvias Children Hospital	Gothenburg	Göteborg
Sweden	Sahlgrenska University Hospital, Dept of Surgery	Gothenburg
Sweden	Dept of Pediatrics, MAS	Malmö
Sweden	National center for child obesity, Karolinska Huddinge	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI development		10 years
Secondary	Medical risk factors, incidence of diseases (such as diabetes, hypertension etc), quality of life, socioeconomic development, eating pattern.		10 years