Insulin Resistance, Metabolic Syndrome, Morbid Obesity, Nonalcoholic Fatty Liver Disease, Obstructive Sleep Apnea Syndrome
Conditions
Keywords
adolescent obesity surgery, bariatric surgery, adjustable gastric banding
Brief 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. 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.
Interventions
DEVICELaparoscopic adjustable gastric banding (Allergan 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.
Sponsors
Jeffrey L Zitsman, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* Ages 13-17 upon entry * BMI \>40 or \>35 with associated medical comorbidities (e.g., sleep apnea, hypertension
Exclusion criteria
* severe psychiatric illness * eating disorder with purging * previous weight loss surgery * stated inability to comply with pre-op and post-op visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Excess Weight Change (EWL) | Baseline and up to 5 years from start of study. | Weight change evaluated in terms of % excess weight loss (EWL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Excess BMI Change | Baseline and up to 5 years from start of study. | Change in Body mass index (BMI) in terms of excess BMI loss (EBMIL). |
Countries
United States
Participant flow
Recruitment details
Adolescents aged 13 to 18 years were enrolled in this study.
Pre-assignment details
The age range for the enrolled adolescents at the time of surgery was 14-19 years of age since some aged from the time of consent to surgery.
Participants by arm
| Arm | Count |
|---|---|
| Adolescents With Morbid Obesity At the time of enrollment, the adolescents with morbid obesity were aged 13-18 years of age and at the time of surgery, the adolescents were aged 14-19 years of age. | 137 |
| Total | 137 |
Baseline characteristics
| Characteristic | Adolescents With Morbid Obesity |
|---|---|
| Age, Continuous | 16.0 years STANDARD_DEVIATION 1.2 |
| Family obesity Adopted (no information) | 2 Participants |
| Family obesity Both | 31 Participants |
| Family obesity Father | 14 Participants |
| Family obesity Mother | 34 Participants |
| Family obesity Neither | 50 Participants |
| Family obesity Yes (not identified) | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 51 Participants |
| Race (NIH/OMB) White | 59 Participants |
| Sex: Female, Male Female | 94 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 137 |
| other Total, other adverse events | 137 / 137 |
| serious Total, serious adverse events | 63 / 137 |
Outcome results
Primary
Percentage of Excess Weight Change (EWL)
Weight change evaluated in terms of % excess weight loss (EWL).
Time frame: Baseline and up to 5 years from start of study.
Population: Includes individuals with confirmed band status at 5 years after surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Gastric Banding | Percentage of Excess Weight Change (EWL) | -35.5 percent change | Standard Deviation 39.4 |
Secondary
Percentage of Excess BMI Change
Change in Body mass index (BMI) in terms of excess BMI loss (EBMIL).
Time frame: Baseline and up to 5 years from start of study.
Population: Includes individuals with confirmed band status at 5 years after surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Gastric Banding | Percentage of Excess BMI Change | 36.6 percent change | Standard Deviation 37.5 |