Obesity
Conditions
Keywords
Obesity, 50 lbs overweight
Brief summary
This study is to evaluate the safety and efficacy of Gastric Banding for patients with body mass index (BMI) between 30-40 kg/m2 with medical conditions related to obesity.
Detailed description
TITLE OF STUDY:A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities CLINICAL PHASE: Phase III new indication for use of the device not yet approved by FDA STUDY OBJECTIVES * To determine the safety and efficacy of the LAP-BAND® Adjustable Gastric Band (LAGB®) for patients with BMI between 30-40 kg/m2 with co-morbidities * To determine long-term effects on patients' co-morbidities STUDY VARIABLES: Morbidity & mortality, percent of excess weight loss, nutritional status, improvement of pre-operative co-morbidities, weight loss maintained, and quality of life evaluation DESIGN: Prospective single center study
Interventions
DEVICELAP-BAND® Adjustable Gastric Band (LAGB®)
Bariatric surgery for patient whose BMI is between 30 and 40 kg/m\^2
Sponsors
Allergan
NYU Langone Health
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
* Be at least 18 and equal to or less than 60 years of age. * BMI of at least 30 and maximum BMI of 40 with co-morbidities * Willingness to comply with dietary restrictions required by the protocol * History of obesity for at least 5 years * History of at least 6 months of documented failures with traditional non-surgical weight loss methods * Willingness to follow protocol requirements * If female with childbearing potential, using an appropriate form of contraception
Exclusion criteria
* Age less than 18, age greater than 60 * Pregnancy * History of major depressive disorder or psychosis * Previous bariatric surgery or previous gastric surgery * Presence of achalasia * Presence of portal hypertension, cirrhosis, and/or varices * Patient with inflammatory disease of the gastrointestinal tract such as Crohn's Disease * Patients with autoimmune connective tissue disorders * Patients with acute abdominal infections * Any condition that, in the judgment of the investigator, would place a subject at undue risk, or potentially compromise the results or interpretation of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery | 5 years | Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery | 5 years | Change in level of Triglycerides from baseline at 5 years |
| Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery | 5 years | Change in level of HbA1c from baseline at 5 years |
| Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery | 5 years | Change in level of LDL from baseline at 5 years |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LAP-BAND® Adjustable Gastric Band (LAGB®) Operations A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | LAP-BAND® Adjustable Gastric Band (LAGB®) Operations |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants |
| BMI | 35.1 kg/m2 STANDARD_DEVIATION 2.6 |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 50 |
| serious Total, serious adverse events | 14 / 50 |
Outcome results
Primary
To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery
Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight.
Time frame: 5 years
Population: All participants who underwent LAGB are included in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LAGB | To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery | 51.74 percentage of excess weight loss | Standard Deviation 27.36 |
Secondary
Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery
Change in level of HbA1c from baseline at 5 years
Time frame: 5 years
Population: All participants who underwent LAGB and had 5 year f/u visit are included in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LAGB | Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery | 5.6 percentage of HbA1c | Standard Deviation 0.6 |
Secondary
Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery
Change in level of LDL from baseline at 5 years
Time frame: 5 years
Population: All participants who underwent LAGB are included in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LAGB | Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery | 117 mg/dl | Standard Deviation 34 |
Secondary
Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery
Change in level of Triglycerides from baseline at 5 years
Time frame: 5 years
Population: All participants who underwent LAGB and had 5 year follow up visit are included in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LAGB | Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery | 103 mg/dl | Standard Deviation 58 |