Morbid ObesityNCT00592202
Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents
A study testing Placement of an adjustable gastric band in people with Morbid Obesity, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Placement of an adjustable gastric band
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Feb 2013
- Phase
- Interventional
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 14 through 17
- BMI greater than 40
- BMI 35 to 40 and also having an obesity related comorbidity
- Have a history of working in a multidisciplinary weight loss program utilizing nutritional training, behavior modification, and activity training
Who cannot join
- Subject history of congenital or acquired anomalies fo the gastrointestinal tract
- Severe cardiopulmonary or other serious organic disease
- Severe coagulopathy
- Hepatic insufficiency or cirrhosis
- History of bariatric gastric or esophageal surgery
- History of intestinal obstruction or adhesive peritonitis
- History of esophageal motility disorders
- Type I diabetes
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.
Read the detailed description
The aim of this research is to evaluate the safety and efficacy of the use of the Lap-Band system in the morbidly obese adolescent population in the United States. We also propose to take advantage of the opportunity for liver biopsy and the data collected for the FDA study in adolescents to answer several questions: 1) what is the true incidence of non-alcoholic fatty liver disease (NAFLD) and its variants in morbidly obese adolescents; 2) what is the course of the NAFLD disease in adolescents who have undergone weight loss, including the progression from steatosis to NASH/ fibrosis or the progression of NASH to cirrhosis? 3) What are the factors implicated in this progression and 4) Is there a link between the excess visceral fat, MS and NAFLD as assessed by parallel changes in metabolic syndrome (MS) and NAFLD following weight loss intervention. The LAPBAND may provide obese adolescents with a significantly less morbid and reversible surgical option for weight loss.
- Conditions
- Morbid Obesity
- Being tested
- Placement of an adjustable gastric band
- Keywords
- Morbid obesity, Adolescents, Gastric restrictive procedure, Adjustable gastric band, Treatment
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of an adjustable gastric bandDevice
Laparoscopic placement of an adjustable gastric band around the upper portion of the stomach and subsequent adjustments of the band via a subcutaneous port as needed to maintain appropriate restriction.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Adolescents between the ages 14 through 17 with a BMI of 40 or more or with a BMI of 35 or more and with an obesity related comorbidity will undergo placement of an adjustable gastric band Receives: Device: Placement of an adjustable gastric band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: Every six months
Secondary outcomes (2)
Resolution of comorbidities
Measured: every six months
Assess the status of comorbidities and changes in quality of life scores from baseline.
Measured: every six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startDec 2004
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bob Kanard, University of Illinois Chicago
- Investigators
- Robert Kanard, M.D., Principal investigator, Division of Pediatric Surgery, UIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592202
- Sponsor's protocol ID
- 2004-0732
- Status last verified
- Mar 2014
- First submitted
- 27 Dec 2007
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents
- ClinicalTrials.gov ID
- NCT00592202
- Acronym / sponsor ID
- 2004-0732
- Conditions
- Morbid Obesity
- Keywords
- Morbid obesity, Adolescents, Gastric restrictive procedure, Adjustable gastric band, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 11 Jan 2008 (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.
The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.
Detailed description
The aim of this research is to evaluate the safety and efficacy of the use of the Lap-Band system in the morbidly obese adolescent population in the United States. We also propose to take advantage of the opportunity for liver biopsy and the data collected for the FDA study in adolescents to answer several questions: 1) what is the true incidence of non-alcoholic fatty liver disease (NAFLD) and its variants in morbidly obese adolescents; 2) what is the course of the NAFLD disease in adolescents who have undergone weight loss, including the progression from steatosis to NASH/ fibrosis or the progression of NASH to cirrhosis? 3) What are the factors implicated in this progression and 4) Is there a link between the excess visceral fat, MS and NAFLD as assessed by parallel changes in metabolic syndrome (MS) and NAFLD following weight loss intervention. The LAPBAND may provide obese adolescents with a significantly less morbid and reversible surgical option for weight loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Placement of an adjustable gastric bandAdolescents between the ages 14 through 17 with a BMI of 40 or more or with a BMI of 35 or more and with an obesity related comorbidity will undergo placement of an adjustable gastric band |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Ages 14 through 17
- BMI greater than 40
- BMI 35 to 40 and also having an obesity related comorbidity
- Have a history of working in a multidisciplinary weight loss program utilizing nutritional training, behavior modification, and activity training
Key exclusion criteria (8 listed)
- Subject history of congenital or acquired anomalies fo the gastrointestinal tract
- Severe cardiopulmonary or other serious organic disease
- Severe coagulopathy
- Hepatic insufficiency or cirrhosis
- History of bariatric gastric or esophageal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placement of an adjustable gastric bandLaparoscopic placement of an adjustable gastric band around the upper portion of the stomach and subsequent adjustments of the band via a subcutaneous port as needed to maintain appropriate restriction. | Device | 1 |
Primary outcome
Weight loss
Time frame: Every six months
2 secondary outcomes
Resolution of comorbidities
Time frame: every six months
Assess the status of comorbidities and changes in quality of life scores from baseline.
Time frame: every six 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 2 Apr 2014.
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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.
Robert Kanard, M.D. principal investigator
Division of Pediatric Surgery, UIC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of an adjustable gastric band in people with Morbid Obesity, run by University of Illinois Chicago at 1 site in United States.
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 4 inclusion and 8 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 2 Apr 2014. 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 United States. 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?
Weight loss (time frame: Every six months). 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 2 Apr 2014.