Obesity
Conditions
Brief summary
The purpose of the study is to evaluate the safety and initial efficacy of the EndoBarrier device compared to a diet control in patients who require weight loss prior to their Bariatric surgery. It is a randomized, prospective controlled, open label, pilot study of 40 patients. Thiry patients will receive an implant of the EndoBarrier device and the other 10 patients will receive the principle investigator's standard of care diet program. All patients will be treated for 12 weeks with the exception of the last 10 device patients who will continue to 24 weeks if the principle investigator determines that it is safe and in their best interest to continue. The primary efficacy endpoint is: * Assessment of the difference in % excess weight loss between the 2 groups Secondary endpoints are: * Resolution or Improvement in type II Diabetic status as defined as: * Resolution = patient is off their diabetes medication and has normal diabetic blood parameters (fasting glucose) * Improvement = normalizing diabetic blood parameters (fasting glucose) and/or a reduction in dosing or frequency of their diabetic medication * The percent of patients who achieve at least a 10% excess weight loss will be calculated as a secondary outcome.
Interventions
DEVICEEndoBarrier Device
NIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp and EndoBarrier Device for 12 weeks
BEHAVIORALDiet & Lifestyle Counseling
NIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp
Sponsors
Morphic Medical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years and \< 55 years - Male or Female * BMI \> 35 with significant comorbidities (i.e. hypertension, or hyperlipidemia, or diabetes) or \> 40 BMI \<60 (with or without a co-morbid condition) * History of failure with nonsurgical weight loss methods * Candidates for Roux-en-Y gastric bypass * Patients willing to comply with study requirements * Patients who have signed an informed consent form
Exclusion criteria
* Patients requiring prescription anticoagulation therapy * Patients with iron deficiency and iron deficiency anemia * Inflammatory bowel disease or condition of the gastrointestinal tract, such as ulcers or Crohn's disease * Treatment represents an unreasonable risk to the patient * Pancreatitis or other serious organic conditions * Symptomatic coronary artery disease or pulmonary dysfunction * Patients with known gallstones prior to implant * Known infection at the time of implant * Severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia * Congenital or acquired anomalies of the GI tract such as atresias or stenoses * Pregnant or has the intention of becoming pregnant in the next 12 months * Unresolved alcohol or drug addiction * HIV Positive patients * Patients with hepatitis B or C * Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement or clinical trial * Previous GI surgery that could affect the ability to place the sleeve or the function of the implant. * Patients unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period * H. pylori positive patients (Note: patients may be enrolled if they had a prior history and were successfully treated) * Patients receiving weight loss medications such as Meridia and Xenical * Family or patient history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder * Patients with gastroesophageal reflux disease (GERD) * Patients with a history of kidney stones * Participating in another ongoing investigational clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Weight Change From Baseline at 12 Weeks in kg | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % of Subjects Achieving at Least a 10% Change in Excess Weight From Baseline to 12 Weeks | 12 weeks | The percent excess weight loss calculated using the Metropolitan Life Tables (MET). The actual amount of excess weight loss (EWL) was examined through the percent of actual weight change from baseline. |
| Count of Subjects With Decrease in HbA1c Values From Baseline to Week 12 | Baseline to Week 12 of treatment | — |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EndoBarrier and Diet/Lifestyle Counseling EndoBarrier + Diet + Lifestyle counseling
EndoBarrier: Monthly visits | 26 |
| Control: (Diet and Lifestyle Counseling) Diet + Lifestyle counseling
Diet + Lifestyle Counseling: Monthly Visits | 11 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | unsuccessful procedure | 4 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | EndoBarrier and Diet/Lifestyle Counseling | Control: (Diet and Lifestyle Counseling) | Total |
|---|---|---|---|
| Age, Continuous | 40.9 years STANDARD_DEVIATION 9.33 | 41.2 years STANDARD_DEVIATION 10.46 | 41.0 years STANDARD_DEVIATION 9.53 |
| Region of Enrollment Netherlands | 26 participants | 11 participants | 37 participants |
| Sex: Female, Male Female | 18 Participants | 9 Participants | 27 Participants |
| Sex: Female, Male Male | 8 Participants | 2 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 26 / 26 | 1 / 11 |
| serious Total, serious adverse events | 1 / 26 | 0 / 11 |
Outcome results
Primary
Total Weight Change From Baseline at 12 Weeks in kg
Time frame: 12 weeks
Population: 26 subjects received the device. 2 subjects had the device removed before 12 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoBarrier/Diet and Lifestyle Counseling/12 Weeks | Total Weight Change From Baseline at 12 Weeks in kg | -13.3 kg | Standard Deviation 5.83 |
| Control (Diet & Lifestyle Counseling) | Total Weight Change From Baseline at 12 Weeks in kg | -5.5 kg | Standard Deviation 5.41 |
Secondary
Count of Subjects With Decrease in HbA1c Values From Baseline to Week 12
Time frame: Baseline to Week 12 of treatment
Population: Type 2 Diabetes Subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EndoBarrier/Diet and Lifestyle Counseling/12 Weeks | Count of Subjects With Decrease in HbA1c Values From Baseline to Week 12 | 8 Participants |
| Control (Diet & Lifestyle Counseling) | Count of Subjects With Decrease in HbA1c Values From Baseline to Week 12 | 1 Participants |
Secondary
% of Subjects Achieving at Least a 10% Change in Excess Weight From Baseline to 12 Weeks
The percent excess weight loss calculated using the Metropolitan Life Tables (MET). The actual amount of excess weight loss (EWL) was examined through the percent of actual weight change from baseline.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EndoBarrier/Diet and Lifestyle Counseling/12 Weeks | % of Subjects Achieving at Least a 10% Change in Excess Weight From Baseline to 12 Weeks | 80.8 % participants |
| Control (Diet & Lifestyle Counseling) | % of Subjects Achieving at Least a 10% Change in Excess Weight From Baseline to 12 Weeks | 27.3 % participants |