ObesityNCT02594514
Laparoscopic Sleeve Gastrectomy in Severely Obese Adolescents: Effects on Metabolism
An observational study of Obesity and Surgery, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2007to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Severe obese adolescents who underwent laparoscopic sleeve gastrectomy
Who may be able to join
- 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.
Who cannot join
- it was a retrospective study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Sleeve Gastrectomy in Severely Obese Adolescents: Effective for Resolution of Cardiovascular Comorbidities
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.
- Keywords
- cardiovascular risk, metabolic profile
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of loss of excess weight following laparoscopic sleeve gastrectomy in severely obese adolescents
weight
Measured: up to 24 months
percent of reduction in body mass index following laparoscopic sleeve gastrectomy in severely obese adolescents
weight and stature
Measured: up to 24 months
Secondary outcomes (8)
Changes in insulin resistance following laparoscopic sleeve gastrectomy in severely obese adolescents
laboratory assessment- fasting insulinemia
Measured: up to 24 months
Changes in total cholesterol and and fractions following laparoscopic sleeve gastrectomy in severely obese adolescents
laboratory assessment-
Measured: up to 24 months
Changes in glucose and and fractions following laparoscopic sleeve gastrectomy in severely obese adolescents
oral glucose tolerance test
Measured: up to 24 months
Changes in transaminases following laparoscopic sleeve gastrectomy in severely obese adolescents
laboratory assessment-
Measured: up to 24 months
Changes in uric acid following laparoscopic sleeve gastrectomy in severely obese adolescents
laboratory assessment-
Measured: up to 24 months
Changes in triglycerides following laparoscopic sleeve gastrectomy in severely obese adolescents
laboratory assessment-
Measured: up to 24 months
Changes in abdominal ultrasonography ( steatosis )following laparoscopic sleeve gastrectomy in severely obese adolescents
abdominal ultrasonography
Measured: up to 24 months
Changes in echocardiogram ( concentric hypertrophy of left ventricle )following laparoscopic sleeve gastrectomy in severely obese adolescents
echocardiogram
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startJan 2007
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Rocha Franco, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594514
- Sponsor's protocol ID
- USaoPauloLSG
- Status last verified
- Oct 2015
- First submitted
- 9 Oct 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Sleeve Gastrectomy in Severely Obese Adolescents: Effective for Resolution of Cardiovascular Comorbidities
- ClinicalTrials.gov ID
- NCT02594514
- Acronym / sponsor ID
- USaoPauloLSG
- Keywords
- cardiovascular risk, metabolic profile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Severe obese adolescents who underwent laparoscopic sleeve gastrectomy
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- it was a retrospective study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent of loss of excess weight following laparoscopic sleeve gastrectomy in severely obese adolescents
Time frame: up to 24 months
weight
percent of reduction in body mass index following laparoscopic sleeve gastrectomy in severely obese adolescents
Time frame: up to 24 months
weight and stature
8 secondary outcomes
Changes in insulin resistance following laparoscopic sleeve gastrectomy in severely obese adolescents
Time frame: up to 24 months
Changes in total cholesterol and and fractions following laparoscopic sleeve gastrectomy in severely obese adolescents
Time frame: up to 24 months
Changes in glucose and and fractions following laparoscopic sleeve gastrectomy in severely obese adolescents
Time frame: up to 24 months
Changes in transaminases following laparoscopic sleeve gastrectomy in severely obese adolescents
Time frame: up to 24 months
Changes in uric acid following laparoscopic sleeve gastrectomy in severely obese adolescents
Time frame: up to 24 months
Changes in triglycerides following laparoscopic sleeve gastrectomy in severely obese adolescents
Time frame: up to 24 months
Changes in abdominal ultrasonography ( steatosis )following laparoscopic sleeve gastrectomy in severely obese adolescents
Time frame: up to 24 months
Changes in echocardiogram ( concentric hypertrophy of left ventricle )following laparoscopic sleeve gastrectomy in severely obese adolescents
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Surgery, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of loss of excess weight following laparoscopic sleeve gastrectomy in severely obese adolescents (time frame: up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015.