Obesity, Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes
Brief summary
The purpose of this study is to determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients
Detailed description
Patients with obesity are at significantly greater risk of developing complications such as pulmonary dysfunction, diabetes, hypertension, and other co-morbid risks. NIH panel recommendations state that even a 10% short-weight loss would greatly reduce these risks. GI Dynamics' GI Sleeve represents a viable alternative to other short-term pre-surgical weight loss methods. GI Sleeve is a device that can be implanted and removed through minimal invasive endoscopic techniques. This endoscopic procedure brings potential benefits to patients in that it is minimally invasive, efficacious, and allows patients to recover faster with less morbidity and mortality.
Interventions
DEVICEGI Liner
Medical device placed endoscopically in the duodenum, nutritional counseling
Sponsors
Morphic Medical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 65 * BMI 40 to 60 * Type II Diabetes * Candidates for bariatric surgery
Exclusion criteria
Patients with * hepatitis B or C * gastroesophageal reflux disease (GERD) * HIV Positive diagnosis * pancreatitis * conditions of gastrointestinal tract, such as ulcers or Crohn's * an infection or who are H. Pylori positive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % of Excess Weight Loss (EWL) | 12 months | Percent excess weight loss (EWL) was calculated using Body Mass Index (BMI25) method: BMI25=ideal weight in kg/(height in meters)2 Ideal weight in kg = 25 x (Height in meters2) Baseline Excess weight = total weight - ideal weight % EWL = (baseline excess weight - weight loss) x 100 |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c Values at 12 Months | 12 months |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EndoBarrier Liner Device Subjects implanted with the EndoBarrier for up to 12 months. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | abdominal tumor, unrelated to device | 1 |
| Overall Study | Adverse Event | 4 |
| Overall Study | Device migration | 2 |
| Overall Study | non-compliance by subject | 2 |
Baseline characteristics
| Characteristic | EndoBarrier Liner Device |
|---|---|
| Age, Continuous | 46.2 years STANDARD_DEVIATION 10.45 |
| Baseline Weight | 119.2 kg STANDARD_DEVIATION 22.87 |
| Percent of glycosylated hemoglobin | 8.9 Percent of glycosylated hemoglobin STANDARD_DEVIATION 1.66 |
| Region of Enrollment Brazil | 22 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 22 / 22 |
| serious Total, serious adverse events | 2 / 22 |
Outcome results
Primary
% of Excess Weight Loss (EWL)
Percent excess weight loss (EWL) was calculated using Body Mass Index (BMI25) method: BMI25=ideal weight in kg/(height in meters)2 Ideal weight in kg = 25 x (Height in meters2) Baseline Excess weight = total weight - ideal weight % EWL = (baseline excess weight - weight loss) x 100
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoBarrier | % of Excess Weight Loss (EWL) | 37.7 % excess weight loss | Standard Deviation 13.6 |
Secondary
HbA1c Values at 12 Months
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoBarrier | HbA1c Values at 12 Months | 6.6 HbA1c (%) | Standard Deviation 1.1 |