Clinical trial NCT02594514: Laparoscopic Sleeve Gastrectomy in Severely Obese Adolescents: Effects on Metabolism
Official title: Laparoscopic Sleeve Gastrectomy in Severely Obese Adolescents: Effective for Resolution of Cardiovascular Comorbidities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Surgery
Keywords: cardiovascular risk
metabolic profile
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 22
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe obese adolescents who underwent laparoscopic sleeve gastrectomy

Brief summary: Severe obesity (SO), defined as BMI≥95th percentile, has increased worldwide among adolescents. American studies estimated that 1.3-2.8% of 12-19-year-old individuals have a BMI \>40 kg/m2 or a BMI \>35 kg/m2 with at least one serious co-morbidity. The immediate and long-term risks associated with SO in adolescents include cardiovascular and metabolic diseases, obstructive sleep apnoea and nonalcoholic fatty liver disease. However, the results of sleeve gastrectomy in adolescents are still uncertain.

Objective and hypotheses: Investigators aimed to assess the long-term safety, efficacy, and cardiovascular risk changes of laparoscopic sleeve gastrectomy in adolescents with SO.

Method: Longitudinal retrospective study of 22 adolescents with SO who underwent laparoscopic sleeve gastrectomy. Clinical and metabolic variables immediately before surgery and after 6, 12, 18 and 24 months were assessed.


Eligibility criteria: Inclusion Criteria:

* ages of 14 and 19
* submitted to LSG between 2007 and 2014.
* attended the child obesity clinic of the pediatric endocrinology department of the Instituto da Criança da Universidade de São Paulo (Children's Institute of University of São Paulo).
* received clinical and pharmacological treatment for at least 6 months before surgery and were followed by a multidisciplinary team including a pediatric endocrinologist, a nutritionist, a psychologist and a physical educator.
* BMI \> 40 kg/m2 or BMI \> 35 kg/m2 with comorbidities and failed to achieve significant weight loss (10% of initial weight at 6 months) through clinical treatment.
* Both the patients and their guardians were informed about the risks and benefits of surgery and provided informed consent.

Exclusion Criteria:

* it was a retrospective study

Primary outcomes:
measure: Percent of loss of excess weight following laparoscopic sleeve gastrectomy in severely obese adolescents
timeFrame: up to 24 months
measure: percent of reduction in body mass index following laparoscopic sleeve gastrectomy in severely obese adolescents
timeFrame: up to 24 months
Secondary outcomes:
measure: Changes in insulin resistance following laparoscopic sleeve gastrectomy in severely obese adolescents
timeFrame: up to 24 months
measure: Changes in total cholesterol and and fractions following laparoscopic sleeve gastrectomy in severely obese adolescents
timeFrame: up to 24 months
measure: Changes in glucose and and fractions following laparoscopic sleeve gastrectomy in severely obese adolescents
timeFrame: up to 24 months
measure: Changes in transaminases following laparoscopic sleeve gastrectomy in severely obese adolescents
timeFrame: up to 24 months
measure: Changes in uric acid following laparoscopic sleeve gastrectomy in severely obese adolescents
timeFrame: up to 24 months
measure: Changes in triglycerides following laparoscopic sleeve gastrectomy in severely obese adolescents
timeFrame: up to 24 months
measure: Changes in abdominal ultrasonography ( steatosis )following laparoscopic sleeve gastrectomy in severely obese adolescents
timeFrame: up to 24 months
measure: Changes in echocardiogram ( concentric hypertrophy of left ventricle )following laparoscopic sleeve gastrectomy in severely obese adolescents
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: HCFUMSP
state: SP
Study officials:
References: