Laparoscopic Sleeve Gastrectomy in Severely Obese Adolescents: Effects on Metabolism

Obesity Clinical Trial

Official title:

Laparoscopic Sleeve Gastrectomy in Severely Obese Adolescents: Effective for Resolution of Cardiovascular Comorbidities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594514
• Other study ID #: USaoPauloLSG
• Status: Completed
• Phase: N/A
• First received: October 9, 2015
• Last updated: October 30, 2015
• Start date: January 2007
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 19 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Obesity
• Surgery

Locations

Country	Name	City	State
Brazil	HCFUMSP	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of loss of excess weight following laparoscopic sleeve gastrectomy in severely obese adolescents	weight	up to 24 months	Yes
Primary	percent of reduction in body mass index following laparoscopic sleeve gastrectomy in severely obese adolescents	weight and stature	up to 24 months	Yes
Secondary	Changes in insulin resistance following laparoscopic sleeve gastrectomy in severely obese adolescents	laboratory assessment- fasting insulinemia	up to 24 months	Yes
Secondary	Changes in total cholesterol and and fractions following laparoscopic sleeve gastrectomy in severely obese adolescents	laboratory assessment-	up to 24 months	Yes
Secondary	Changes in glucose and and fractions following laparoscopic sleeve gastrectomy in severely obese adolescents	oral glucose tolerance test	up to 24 months	Yes
Secondary	Changes in transaminases following laparoscopic sleeve gastrectomy in severely obese adolescents	laboratory assessment-	up to 24 months	Yes
Secondary	Changes in uric acid following laparoscopic sleeve gastrectomy in severely obese adolescents	laboratory assessment-	up to 24 months	Yes
Secondary	Changes in triglycerides following laparoscopic sleeve gastrectomy in severely obese adolescents	laboratory assessment-	up to 24 months	Yes
Secondary	Changes in abdominal ultrasonography ( steatosis )following laparoscopic sleeve gastrectomy in severely obese adolescents	abdominal ultrasonography	up to 24 months	Yes
Secondary	Changes in echocardiogram ( concentric hypertrophy of left ventricle )following laparoscopic sleeve gastrectomy in severely obese adolescents	echocardiogram	up to 24 months	Yes