Morbid ObesityNCT01045499
LAGB as a Treatment for Morbid Obesity in Adolescents
A study testing Laparoscopic adjustable gastric banding (Allergan Lap Band) in people with Morbid Obesity and Obstructive Sleep Apnea Syndrome, run by Jeffrey L Zitsman, MD at 1 site in United States.
Trial summary
Laparoscopic adjustable gastric banding (LAGB) has been used worldwide to help selected morbidly obese adults to lose weight. The FDA has approved LAGB only for patients 18 years or older. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Morbid Obesity, Obstructive Sleep Apnea Syndrome, Metabolic Syndrome
- What is being tested?
- Laparoscopic adjustable gastric banding (Allergan Lap Band)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2005to 30 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 13-17 upon entry
- BMI >40 or >35 with associated medical comorbidities (e.g., sleep apnea, hypertension
Who cannot join
- severe psychiatric illness
- eating disorder with purging
- previous weight loss surgery
- stated inability to comply with pre-op and post-op visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Morgan Stanley Children's Hospital of NY Presbyterian
New York, New York, 10032
About this study
Official title: Laparoscopic Adjustable Gastric Banding (LAGB) as a Treatment for Morbid Obesity in Adolescents
Laparoscopic adjustable gastric banding (LAGB) has been used worldwide to help selected morbidly obese adults to lose weight. The FDA has approved LAGB only for patients 18 years or older. Our hypothesis that LAGB can be used to assist selected adolescents between 14 and 17 years lose weight and that the procedure can be performed safely in this age group. We are also evaluating the effects of weight loss after LAGB on known comorbid conditions such as sleep apnea syndrome and insulin resistance, and also on psychological health.
Read the detailed description
Seventy to ninety-eight percent of obese children become obese adults. Comorbidities of obesity such as type II diabetes, fatty liver disease, hyperlipidemia, hypertension, asthma, sleep apnea, and depression are becoming increasing common in adolescents as more adolescents become obese. The only consistently durable and effective weight loss programs for the morbidly obese patients are those that include bariatric surgical procedures. The investigators believe that the best initial bariatric surgical option for adolescents is LAGB because of its low complication rates, adjustability, and reversibility. Obese adolescents ages 14-17 who meet criteria for entry will be enrolled to determine the degree of success of LAGB as measured by % excess weight loss, decreased % body fat, decreased body mass index (BMI), reduction in comorbid conditions, and metabolic parameters (including serum lipids and glucose tolerance) at intervals of 3 months, 6 months, 1 year, then annually for a total of 5 years postoperatively. Eligible patients will have been followed for 6 months by physicians in the Center for Adolescent Bariatric Surgery and: 1) will attended a minimum of 75% of visits and 2) will have failed to lose at least 20% of excess weight. Following evaluation by the team (which will include evaluations by a nutritionist, an endocrinologist, a psychologist/psychiatrist, a pediatric nurse practitioner, and a surgeon) a patient may be offered LAGB.
- Conditions
- Morbid Obesity, Obstructive Sleep Apnea Syndrome, Metabolic Syndrome, Insulin Resistance, Nonalcoholic Fatty Liver Disease
- Being tested
- Laparoscopic adjustable gastric banding (Allergan Lap Band)
- Keywords
- adolescent obesity surgery, bariatric surgery, adjustable gastric banding
- Medical subject headings
- Obesity, Morbid, Sleep Apnea, Obstructive, Metabolic Syndrome, Insulin Resistance, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic adjustable gastric banding (Allergan Lap Band)Device
Also called LAP-BAND®
Pre-op evaluation, surgical placement of a gastric band, and follow-up for a minimum of 5 years after surgery. Surgery is laparoscopic adjustable gastric band placement using a single brand of gastric band. Evaluations before and after surgery include but are not limited to history and physical examination, serum chemistry studies, imaging, sleep studies, and pulmonary function testing.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic gastric banding | Experimental | Adolescent patients who have undergone laparoscopic adjustable gastric banding. Weight, BMI, and co-morbidity data will be compared to patient's pre-operative values. Receives: Device: Laparoscopic adjustable gastric banding (Allergan Lap Band) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Excess Weight Change (EWL)
Weight change evaluated in terms of % excess weight loss (EWL).
Measured: Baseline and up to 5 years from start of study.
Secondary outcomes (1)
Percentage of Excess BMI Change
Change in Body mass index (BMI) in terms of excess BMI loss (EBMIL).
Measured: Baseline and up to 5 years from start of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study start13 Sep 2005
- Primary completion31 Jul 2016
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- 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
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey L Zitsman, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeffrey L Zitsman, MD, Columbia University
- Investigators
- Jeffrey L Zitsman, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045499
- Sponsor's protocol ID
- AAAB1759
- Status last verified
- Mar 2020
- First submitted
- 7 Jan 2010
- Last updated
- 13 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Sysko R, Devlin MJ, Hildebrandt TB, Brewer SK, Zitsman JL, Walsh BT. Psychological outcomes and predictors of initial weight loss outcomes among severely obese adolescents receiving laparoscopic adjustable gastric banding. J Clin Psychiatry. 2012 Oct;73(10):1351-7. doi: 10.4088/JCP.12m07690.
PubMed 23140654Sysko R, Zakarin EB, Devlin MJ, Bush J, Walsh BT. A latent class analysis of psychiatric symptoms among 125 adolescents in a bariatric surgery program. Int J Pediatr Obes. 2011 Aug;6(3-4):289-97. doi: 10.3109/17477166.2010.545411. Epub 2011 Feb 8.
PubMed 21299450
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Adjustable Gastric Banding (LAGB) as a Treatment for Morbid Obesity in Adolescents
- ClinicalTrials.gov ID
- NCT01045499
- Acronym / sponsor ID
- AAAB1759
- Conditions
- Morbid Obesity, Obstructive Sleep Apnea Syndrome, Metabolic Syndrome, Insulin Resistance, Nonalcoholic Fatty Liver Disease
- Keywords
- adolescent obesity surgery, bariatric surgery, adjustable gastric banding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Jeffrey L Zitsman, MDUniversity, hospital or other
- Study start
- 13 Sep 2005 (actual)
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 11 Jan 2010 (estimated)
- Results
- Posted 13 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laparoscopic adjustable gastric banding (LAGB) has been used worldwide to help selected morbidly obese adults to lose weight. The FDA has approved LAGB only for patients 18 years or older. Our hypothesis that LAGB can be used to assist selected adolescents between 14 and 17 years lose weight and that the procedure can be performed safely in this age group. We are also evaluating the effects of weight loss after LAGB on known comorbid conditions such as sleep apnea syndrome and insulin resistance, and also on psychological health.
Detailed description
Seventy to ninety-eight percent of obese children become obese adults. Comorbidities of obesity such as type II diabetes, fatty liver disease, hyperlipidemia, hypertension, asthma, sleep apnea, and depression are becoming increasing common in adolescents as more adolescents become obese. The only consistently durable and effective weight loss programs for the morbidly obese patients are those that include bariatric surgical procedures. The investigators believe that the best initial bariatric surgical option for adolescents is LAGB because of its low complication rates, adjustability, and reversibility. Obese adolescents ages 14-17 who meet criteria for entry will be enrolled to determine the degree of success of LAGB as measured by % excess weight loss, decreased % body fat, decreased body mass index (BMI), reduction in comorbid conditions, and metabolic parameters (including serum lipids and glucose tolerance) at intervals of 3 months, 6 months, 1 year, then annually for a total of 5 years postoperatively. Eligible patients will have been followed for 6 months by physicians in the Center for Adolescent Bariatric Surgery and: 1) will attended a minimum of 75% of visits and 2) will have failed to lose at least 20% of excess weight. Following evaluation by the team (which will include evaluations by a nutritionist, an endocrinologist, a psychologist/psychiatrist, a pediatric nurse practitioner, and a surgeon) a patient may be offered LAGB.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| laparoscopic gastric banding | Experimental | Device: Laparoscopic adjustable gastric banding (Allergan Lap Band)Adolescent patients who have undergone laparoscopic adjustable gastric banding. Weight, BMI, and co-morbidity data will be compared to patient's pre-operative values. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Ages 13-17 upon entry
- BMI >40 or >35 with associated medical comorbidities (e.g., sleep apnea, hypertension
Key exclusion criteria (4 listed)
- severe psychiatric illness
- eating disorder with purging
- previous weight loss surgery
- stated inability to comply with pre-op and post-op visits
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 |
|---|---|---|
| Laparoscopic adjustable gastric banding (Allergan Lap Band)Also: LAP-BAND®Pre-op evaluation, surgical placement of a gastric band, and follow-up for a minimum of 5 years after surgery. Surgery is laparoscopic adjustable gastric band placement using a single brand of gastric band. Evaluations before and after surgery include but are not limited to history and physical examination, serum chemistry studies, imaging, sleep studies, and pulmonary function testing. | Device | laparoscopic gastric banding |
Primary outcome
Percentage of Excess Weight Change (EWL)
Time frame: Baseline and up to 5 years from start of study.
Weight change evaluated in terms of % excess weight loss (EWL).
1 secondary outcome
Percentage of Excess BMI Change
Time frame: Baseline and up to 5 years from start of study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23140654Sysko R, Devlin MJ, Hildebrandt TB, Brewer SK, Zitsman JL, Walsh BT. Psychological outcomes and predictors of initial weight loss outcomes among severely obese adolescents receiving laparoscopic adjustable gastric banding. J Clin Psychiatry. 2012 Oct;73(10):1351-7. doi: 10.4088/JCP.12m07690.
- Derived from this study: PubMed 21299450Sysko R, Zakarin EB, Devlin MJ, Bush J, Walsh BT. A latent class analysis of psychiatric symptoms among 125 adolescents in a bariatric surgery program. Int J Pediatr Obes. 2011 Aug;6(3-4):289-97. doi: 10.3109/17477166.2010.545411. Epub 2011 Feb 8.
- Individual participant dataSharing planned: Undecided
Related trials for Morbid Obesity
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
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.
Jeffrey L Zitsman, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic adjustable gastric banding (Allergan Lap Band) in people with Morbid Obesity and Obstructive Sleep Apnea Syndrome, run by Jeffrey L Zitsman, MD 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 2 inclusion and 4 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 13 Apr 2020. 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?
Yes. Results are posted in the registry (first posted 13 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Excess Weight Change (EWL) (time frame: Baseline and up to 5 years from start of study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01045499, which also lists 2 linked publications.
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 13 Apr 2020.