Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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Study will monitor weight loss and metabolic indicators for subjects in multi-center, single arm trial.

Detailed Description
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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)

Official Title
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A Trial for a Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus

Conditions
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Obesity, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Device: Self Forming Magnetic (SFM) Anastomosis System


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Placement<br>The subjects in this arm will receive the Self-Forming Magnet (SFM) System that will be used to create a duodenal-ileal diversion. Following the diversion creation, a sleeve gastrectomy will also be performed. | Device: Self Forming Magnetic (SFM) Anastomosis System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | Weight loss measured as a percent of total body weight (TBW) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Responders | Percent responders; i.e. percent of subjects losing at least 10% TBW | 12 months | 
| Excess Weight Loss Measures | Excess weight loss (EWL) | 12 months | 
| Absolute Weight Loss Measures | Absolute weight loss | 12 months | 
| BMI - Weight Loss Measures | Change in BMI | 12 months | 
| Fasting Glucose | Mean change in fasting glucose | 12 months | 
| Hemoglobin A1c | Mean change in Hemoglobin A1c | 12 months | 
| Diabetes Remission and/or Improvements | Proportion of subjects experiencing diabetes remission and/or improvements | 12 months | 
| Diabetes Medication Dosage and Frequency Changes | Mean change in the dosage and frequency of diabetes medications from baseline | 12 months | 
| Serum Lipids | Mean change in serum lipids | 12 months | 
| Blood Pressure Changes | Mean percent change in systolic/diastolic blood pressure | 12 months | 
| Liver Changes using Fibroscan | Change in Controlled Attenuation Parameter (CAP) Scores from baseline | 12 months | 
| Nutritional Status | Nutritional Status: changes in pre-albumin levels | 12 months | 
| Albumin - Nutritional Status | Nutritional Status: changes in albumin levels | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Diabetes Mellitus, Diabetes Mellitus, Type 2, Metabolic Disease, Sleeve Gastrectomy