Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes MellitusObesity
- Interventions
- Device: Self Forming Magnetic (SFM) Anastomosis System
- Registration Number
- NCT04627103
- Lead Sponsor
- GI Windows, Inc.
- 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)
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 18
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Device Placement Self Forming Magnetic (SFM) Anastomosis System 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.
- Primary Outcome Measures
Name Time Method Weight Loss 12 months Weight loss measured as a percent of total body weight (TBW)
- Secondary Outcome Measures
Name Time Method Liver Changes using Fibroscan 12 months Change in Controlled Attenuation Parameter (CAP) Scores from baseline
Excess Weight Loss Measures 12 months Excess weight loss (EWL)
Absolute Weight Loss Measures 12 months Absolute weight loss
Diabetes Medication Dosage and Frequency Changes 12 months Mean change in the dosage and frequency of diabetes medications from baseline
Blood Pressure Changes 12 months Mean percent change in systolic/diastolic blood pressure
Albumin - Nutritional Status 12 months Nutritional Status: changes in albumin levels
Serum Lipids 12 months Mean change in serum lipids
Percent Responders 12 months Percent responders; i.e. percent of subjects losing at least 10% TBW
Hemoglobin A1c 12 months Mean change in Hemoglobin A1c
Diabetes Remission and/or Improvements 12 months Proportion of subjects experiencing diabetes remission and/or improvements
BMI - Weight Loss Measures 12 months Change in BMI
Fasting Glucose 12 months Mean change in fasting glucose
Nutritional Status 12 months Nutritional Status: changes in pre-albumin levels
Trial Locations
- Locations (2)
Université Laval
🇨🇦Quebec City, Quebec, Canada
QEII Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada