Obesity, Type 2 Diabetes Mellitus
Conditions
Keywords
Obesity, Diabetes Mellitus, Diabetes Mellitus, Type 2, Metabolic Disease, Sleeve Gastrectomy
Brief summary
Study will monitor weight loss and metabolic indicators for subjects in multi-center, single arm trial.
Detailed description
Multi-Center, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion with a Sleeve Gastrectomy (SNAP-S) for Subjects with Obesity and Type 2 Diabetes Mellitus (T2DM)
Interventions
The SFM will be placed using an endoscope in the duodenum and laparoscopically into the ileum. A compression anastomosis will be created in each of the subjects and the diversion of enteral flow from the duodenum to ileum will create a metabolic effect that will induce weight loss and impact Type 2 Diabetes. Following the diversion being created, a gastric sleeve will be created according to standard technique.
Sponsors
GI Windows, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 19-65 years at screening * Body mass index (BMI) ≥35 and ≤50 * T2DM diagnosis ≥6 months but \< 10 years, with 1 or more oral diabetes medications, HbA1c ≥ 6.5% but \< 10.0% at time of enrollment. * HbA1c must be stable over a 3-month period. * Weight stable over 3-month period * Obesity-related comorbidities (hypertension, dyslipidemia, sleep apnea) must be well-controlled * Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years * If female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period * Able to understand and sign informed consent documents.
Exclusion criteria
* Known or suspected allergy to nickel or titanium or nitinol * Type 1 diabetes or poorly controlled type 2 diabetes * Use of injectable insulin * Any documented conditions for which endoscopy would be contraindicated * Contraindication to general anesthesia * History of chronic gastrointestinal disease * Congenial or acquired anomalies of the GI tract * Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon. * Uncontrolled hypertension * Pre-existing severe comorbid cardio-respiratory disease * History of chronic gastrointestinal disease * Specific genetic or hormonal cause of obesity * Recent tobacco/nicotine product cessation (within 3 months prior)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | 12 months | Weight loss measured as a percent of total body weight (TBW) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Responders | 12 months | Percent responders; i.e. percent of subjects losing at least 10% TBW |
| Excess Weight Loss Measures | 12 months | Excess weight loss (EWL) |
| Absolute Weight Loss Measures | 12 months | Absolute weight loss |
| BMI - Weight Loss Measures | 12 months | Change in BMI |
| Fasting Glucose | 12 months | Mean change in fasting glucose |
| Hemoglobin A1c | 12 months | Mean change in Hemoglobin A1c |
| Nutritional Status | 12 months | Nutritional Status: changes in pre-albumin levels |
| Diabetes Medication Dosage and Frequency Changes | 12 months | Mean change in the dosage and frequency of diabetes medications from baseline |
| Serum Lipids | 12 months | Mean change in serum lipids |
| Blood Pressure Changes | 12 months | Mean percent change in systolic/diastolic blood pressure |
| Liver Changes using Fibroscan | 12 months | Change in Controlled Attenuation Parameter (CAP) Scores from baseline |
| Albumin - Nutritional Status | 12 months | Nutritional Status: changes in albumin levels |
| Diabetes Remission and/or Improvements | 12 months | Proportion of subjects experiencing diabetes remission and/or improvements |
Countries
Canada
Outcome results
None listed