Laparoscopic Sleeve Gastrectomy in Severely Obese Adolescents: Effects on Metabolism

NCT02594514 | Completed

• 1 other identifier: USaoPauloLSG
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Surgery

Keywords

cardiovascular risk; metabolic profile

Outcome Measures

Primary Outcomes (2)

• Percent of loss of excess weight following laparoscopic sleeve gastrectomy in severely obese adolescents

  weight

  up to 24 months

• percent of reduction in body mass index following laparoscopic sleeve gastrectomy in severely obese adolescents

  weight and stature

  up to 24 months

Secondary Outcomes (8)

• Changes in insulin resistance following laparoscopic sleeve gastrectomy in severely obese adolescents

  up to 24 months

• Changes in total cholesterol and and fractions following laparoscopic sleeve gastrectomy in severely obese adolescents

  up to 24 months

• Changes in glucose and and fractions following laparoscopic sleeve gastrectomy in severely obese adolescents

  up to 24 months

• Changes in transaminases following laparoscopic sleeve gastrectomy in severely obese adolescents

  up to 24 months

• Changes in uric acid following laparoscopic sleeve gastrectomy in severely obese adolescents

  up to 24 months

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Severe obese adolescents who underwent laparoscopic sleeve gastrectomy

You may qualify if:

• 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.

You may not qualify if:

• it was a retrospective study

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

HCFUMSP

São Paulo, São Paulo, 0543-010, Brazil

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 9, 2015
• First Posted: November 3, 2015
• Study Start: January 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 3, 2015

Record last verified: 2015-10

Locations

BR (1)