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Completed

NCT Number: NCT02594514

Laparoscopic Sleeve Gastrectomy in Severely Obese Adolescents: Effects on Metabolism

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.

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Key information

Conditions

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

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HCFUMSP

São Paulo, 0543-010, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: up to 24 months

    weight

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

    Time frame: up to 24 months

    weight and stature

Secondary outcomes

  1. Changes in insulin resistance following laparoscopic sleeve gastrectomy in severely obese adolescents

    Time frame: up to 24 months

    laboratory assessment- fasting insulinemia

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

    Time frame: up to 24 months

    laboratory assessment-

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

    Time frame: up to 24 months

    oral glucose tolerance test

  4. Changes in transaminases following laparoscopic sleeve gastrectomy in severely obese adolescents

    Time frame: up to 24 months

    laboratory assessment-

  5. Changes in uric acid following laparoscopic sleeve gastrectomy in severely obese adolescents

    Time frame: up to 24 months

    laboratory assessment-

  6. Changes in triglycerides following laparoscopic sleeve gastrectomy in severely obese adolescents

    Time frame: up to 24 months

    laboratory assessment-

  7. Changes in abdominal ultrasonography ( steatosis )following laparoscopic sleeve gastrectomy in severely obese adolescents

    Time frame: up to 24 months

    abdominal ultrasonography

  8. Changes in echocardiogram ( concentric hypertrophy of left ventricle )following laparoscopic sleeve gastrectomy in severely obese adolescents

    Time frame: up to 24 months

    echocardiogram

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Nov 3, 2015
Registry last updated
Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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