Obesity, Morbid
Conditions
Keywords
Obesity, Morbid, Obesity, Body Weight
Brief summary
The purpose of this study is to determine whether the Swedish Adjustable Gastric Band (SAGB) is safe, and effective in achieving weight loss in patients with Morbid Obesity.
Detailed description
Surgical treatment of morbidly obese patients is considered a reasonable option for achieving weight loss when more conservative measures, such as diet and exercise have failed. Not only can weight loss be achieved, but also reduction / resolution of a patient's co-morbidities associated with excess weight. Adjustable gastric banding provides a less invasive, reversible bariatric surgery option. The SAGB has been commercially available outside the United States for this indication since 1996. Commercial availability has led to extensive literature supporting the safety and effectiveness of the SAGB. Given the available literature, a prospective, single arm, multicenter, study in a heterogeneous population of morbidly obese subjects in the U.S. is being conducted.
Interventions
DEVICESwedish Adjustable Gastric Band
Long term implantable device.
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Able to comprehend, follow and give signed informed consent; * 18 to 60 years of age (inclusive); * Five year history of morbid obesity; * Body Mass Index (BMI) \>40 kg/m2 and \<55 kg/m2, or BMI \>35 kg/m2 and \<40 kg/m2 with one or more significant medical conditions related to obesity (co-morbid conditions of type 2 diabetes, hyperlipidemia, obstructive sleep apnea, hypertension, metabolic syndrome, or osteoarthritis of the hip or knee) for which the subject is being treated, and which are generally expected to be improved, reversed, or resolved by weight loss. * 100 lbs. overweight or 1.5 times ideal weight; * Documented failure of conservative, non-surgical means of weight reduction within one year prior to the Screening Visit, including failure of supervised diet, exercise and or behavior modification programs, and pharmacologic therapy; * Willing to commit to significant lifestyle changes that include diet, eating, and exercise habits for the duration of the clinical trial; * Able to commit to long-term follow-up, including band adjustment visits: * Living within the contiguous U.S. and is within a 100 mile radius of the study center; * Absence of significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations, as documented during screening assessment; * Agrees to refrain from any type of reconstructive surgery that would affect body weight such as abdominal lipoplasty or liposuction, mammoplasty, or removal of excess skin for the follow-up period following SAGB placement; and * Candidate for surgical weight loss intervention (i.e., meets accepted health criteria for major surgery).
Exclusion criteria
* Women of childbearing potential who are not practicing an effective method of birth control or who are pregnant or lactating; * Previous malabsorptive or restrictive procedures performed for the treatment of obesity; * Documented history of drug and/or alcohol abuse within two years of the Screening Visit; * History of impaired mental status including, but not limited to active substance abuse, a history of schizophrenia, borderline personality disorder, uncontrolled depression, suicidal attempts within the past two years or current suicidal tendencies or ideations; * Presence of any of the following medical conditions; * Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn's disease that have been active within the past 10 years; * Congenital or acquired anomalies of the GI tract, including atresias or stenosis, * Severe cardiopulmonary disease or other serious organic disease that makes the subject a high-risk surgical candidate; * Uncontrolled hypertension; * Portal Hypertension; * Uncontrolled Diabetes Mellitus; * Chronic or acute upper gastrointestinal bleeding conditions, e.g. gastric or esophageal varices; * Cirrhosis; * Congenital or acquired intestinal telangiectasia; * Esophageal or gastric disorders including severe preoperative reflux, dysmotility, or Barrett's Esophagus; * Presence of hiatal hernia; * Prior surgery of the foregut including hiatal hernia repair or prior gastric surgery; * Chronic pancreatitis; * Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders; * Conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study; * History or presence of pre-existing autoimmune connective tissue disease, i.e., systemic lupus erythematosus or scleroderma; * Presence of terminal illness with life expectancy \<5 years; * Use of prescription or over the counter weight reduction medications or supplements within one month of the Screening Visit and for the duration of study participation; * Acute or chronic infection (localized or systemic); * Known or suspected allergy to silicone or other materials contained in the Swedish Adjustable Gastric Band; * History of intolerance to implanted devices; * Not ambulatory; and * Participation in another clinical trial within 8 weeks of the Screening Visit and for the duration of this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB) | 3 years | Percent of device-related adverse events (AEs) and device malfunctions occurring in subjects implanted with the Swedish Adjustable Gastric Band from baseline throughout the three-year post-operative period. |
| Percent Excess Weight Loss | 3 Years Post Operative | Percent Excess Weight Loss (%EWL) with the SAGB at three years post operatively minus baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Absolute Weight | 3 years | Absolute weight loss as measured on a standardized Tanita Scale (used at all sites) at three-years post-operative minus baseline. |
| Changes in Quality of Life (QOL) Measures | 3 years | Changes in QOL measures at three-years post-operative minus baseline. SF-36 scores from 0-100 with higher scores representing better QOL. |
| Changes in Glycosylated Hemoglobin (HbA1c) | 3 years | Changes in glycosylated hemoglobin (HbA1c), from baseline to three-years post-operative. |
| Changes in Excess Body Weight (EBW) | 3 years | Changes in excess body weight at 3-years post-operative minus baseline excess weight. Excess weight is computed as baseline weight minus Ideal weight. Ideal weight as provided in the 1983 Metropolitan Life Height and Weight Table using the upper limit of the midpoint range. |
| Changes in High Density Lipoproteins (HDL) | 3 year | Changes in High Density Lipoproteins (HDL), at three-years post-operative minus baseline. |
| Changes in Low Density Lipoproteins (LDL) | 3 years | Changes in Low Density Lipoproteins (LDL), at three-years post-operative minus baseline. |
| Changes in Total Cholesterol | 3 years | Changes in Total Cholesterol, at three-years post-operative minus baseline. |
| Number of All Adverse Events of Subjects Implanted With the SAGB | 3 Years | The evaluation of all Adverse Events of subjects implanted with the Swedish Adjustable Gastric Band throughout the three-year post-operative period (related to device and unrelated to device). |
| Changes in Body Mass Index (BMI) | 3 years | Changes in Body Mass Index (BMI) at three-years post-operative minus baseline. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at twelve U.S. sites representative of the intended use of the SAGB in terms of both the subject population and the medical community. Subjects were recruited from a wide, heterogeneous subject population. Dates of recruitment June, 2003 to November, 2003.
Pre-assignment details
405 Subjects were consented. 129 did not meet screening criteria. 276 subjects were enrolled and received the SAGB device.
Participants by arm
| Arm | Count |
|---|---|
| Swedish Adjustable Gastric Band (SAGB) | 276 |
| Total | 276 |
Baseline characteristics
| Characteristic | Swedish Adjustable Gastric Band (SAGB) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 276 Participants |
| Age, Continuous | 38.6 years STANDARD_DEVIATION 9.4 |
| Mean Excess Body Weight | 130.0 Pounds STANDARD_DEVIATION 33.1 |
| Region of Enrollment United States | 276 participants |
| Sex: Female, Male Female | 216 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 266 / 276 |
| serious Total, serious adverse events | 78 / 276 |
Outcome results
Primary
Percent Excess Weight Loss
Percent Excess Weight Loss (%EWL) with the SAGB at three years post operatively minus baseline.
Time frame: 3 Years Post Operative
Population: Intent to Treat (ITT), Last Observation Carried Forward (LOCF)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Swedish Adjustable Gastric Band (SAGB) | Percent Excess Weight Loss | 41.1 Percent Excess Weight Loss |
Comparison: A one-sided paired t-test would have 80% power to reject the null hypothesis in favor of the alternative (i.e., that the SAGB system is not inferior to the clinically meaningful result of 36.2 for 224 subjects) assuming: a standard deviation (SD) of (21.6), an equivalent limit difference of (3.6), and a significance level of 0.05.p-value: <0.001t-test, 1 sided
Primary
Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB)
Percent of device-related adverse events (AEs) and device malfunctions occurring in subjects implanted with the Swedish Adjustable Gastric Band from baseline throughout the three-year post-operative period.
Time frame: 3 years
Population: Intent to Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Swedish Adjustable Gastric Band (SAGB) | Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB) | 69.6 Percent of Subjects |
Comparison: A sample size of 215, the adverse event (AE) rate at three years could be estimated with precision as determined by the interval half-width of approximately ± 7%.95% CI: [63.8, 74.9]
Secondary
Change in Absolute Weight
Absolute weight loss as measured on a standardized Tanita Scale (used at all sites) at three-years post-operative minus baseline.
Time frame: 3 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Swedish Adjustable Gastric Band (SAGB) | Change in Absolute Weight | 51.3 Pounds | Standard Deviation 30.8 |
95% CI: [47.6, 54.9]
Secondary
Changes in Body Mass Index (BMI)
Changes in Body Mass Index (BMI) at three-years post-operative minus baseline.
Time frame: 3 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Swedish Adjustable Gastric Band (SAGB) | Changes in Body Mass Index (BMI) | 35.7 kg/m2 | Standard Deviation 6.2 |
95% CI: [34.9, 36.5]
Secondary
Changes in Excess Body Weight (EBW)
Changes in excess body weight at 3-years post-operative minus baseline excess weight. Excess weight is computed as baseline weight minus Ideal weight. Ideal weight as provided in the 1983 Metropolitan Life Height and Weight Table using the upper limit of the midpoint range.
Time frame: 3 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Swedish Adjustable Gastric Band (SAGB) | Changes in Excess Body Weight (EBW) | 75.7 Pounds | Standard Deviation 39.8 |
95% CI: [70.5, 80.8]
Secondary
Changes in Glycosylated Hemoglobin (HbA1c)
Changes in glycosylated hemoglobin (HbA1c), from baseline to three-years post-operative.
Time frame: 3 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Swedish Adjustable Gastric Band (SAGB) | Changes in Glycosylated Hemoglobin (HbA1c) | 5.7 Percent of total hemogloobin | Standard Deviation 0.7 |
95% CI: [5.6, 5.8]
Secondary
Changes in High Density Lipoproteins (HDL)
Changes in High Density Lipoproteins (HDL), at three-years post-operative minus baseline.
Time frame: 3 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Swedish Adjustable Gastric Band (SAGB) | Changes in High Density Lipoproteins (HDL) | 56.4 Mg/dl | Standard Deviation 14.7 |
95% CI: [54.5, 58.4]
Secondary
Changes in Low Density Lipoproteins (LDL)
Changes in Low Density Lipoproteins (LDL), at three-years post-operative minus baseline.
Time frame: 3 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Swedish Adjustable Gastric Band (SAGB) | Changes in Low Density Lipoproteins (LDL) | 114.5 Mg/dl | Standard Deviation 32.3 |
95% CI: [110.1, 118.8]
Secondary
Changes in Quality of Life (QOL) Measures
Changes in QOL measures at three-years post-operative minus baseline. SF-36 scores from 0-100 with higher scores representing better QOL.
Time frame: 3 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Swedish Adjustable Gastric Band (SAGB) | Changes in Quality of Life (QOL) Measures | 10.4 Units on a scale | Standard Deviation 10.3 |
95% CI: [9.2, 11.7]
Secondary
Changes in Total Cholesterol
Changes in Total Cholesterol, at three-years post-operative minus baseline.
Time frame: 3 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Swedish Adjustable Gastric Band (SAGB) | Changes in Total Cholesterol | 193.5 Mg/dl | Standard Deviation 36.9 |
95% CI: [188.6, 198.4]
Secondary
Number of All Adverse Events of Subjects Implanted With the SAGB
The evaluation of all Adverse Events of subjects implanted with the Swedish Adjustable Gastric Band throughout the three-year post-operative period (related to device and unrelated to device).
Time frame: 3 Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Swedish Adjustable Gastric Band (SAGB) | Number of All Adverse Events of Subjects Implanted With the SAGB | 2400 Total Number of Adverse Events |