Back to resultsProcedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus
Primary Purpose
Obesity, Type 2 Diabetes Mellitus
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Self Forming Magnetic (SFM) Anastomosis System
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Diabetes Mellitus, Diabetes Mellitus, Type 2, Metabolic Disease, Sleeve Gastrectomy
Eligibility Criteria
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)
Sites / Locations
- QEII Health Sciences Centre
- Université Laval
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Device Placement
Arm Description
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.
Outcomes
Primary Outcome Measures
Weight Loss
Weight loss measured as a percent of total body weight (TBW)
Secondary Outcome Measures
Percent Responders
Percent responders; i.e. percent of subjects losing at least 10% TBW
Excess Weight Loss Measures
Excess weight loss (EWL)
Absolute Weight Loss Measures
Absolute weight loss
BMI - Weight Loss Measures
Change in BMI
Fasting Glucose
Mean change in fasting glucose
Hemoglobin A1c
Mean change in Hemoglobin A1c
Diabetes Remission and/or Improvements
Proportion of subjects experiencing diabetes remission and/or improvements
Diabetes Medication Dosage and Frequency Changes
Mean change in the dosage and frequency of diabetes medications from baseline
Serum Lipids
Mean change in serum lipids
Blood Pressure Changes
Mean percent change in systolic/diastolic blood pressure
Liver Changes using Fibroscan
Change in Controlled Attenuation Parameter (CAP) Scores from baseline
Nutritional Status
Nutritional Status: changes in pre-albumin levels
Albumin - Nutritional Status
Nutritional Status: changes in albumin levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04627103
Brief Title
Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus
Official Title
A Trial for a Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
October 7, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GI Windows, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes Mellitus
Keywords
Obesity, Diabetes Mellitus, Diabetes Mellitus, Type 2, Metabolic Disease, Sleeve Gastrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device Placement
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Self Forming Magnetic (SFM) Anastomosis System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight Loss
Description
Weight loss measured as a percent of total body weight (TBW)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percent Responders
Description
Percent responders; i.e. percent of subjects losing at least 10% TBW
Time Frame
12 months
Title
Excess Weight Loss Measures
Description
Excess weight loss (EWL)
Time Frame
12 months
Title
Absolute Weight Loss Measures
Description
Absolute weight loss
Time Frame
12 months
Title
BMI - Weight Loss Measures
Description
Change in BMI
Time Frame
12 months
Title
Fasting Glucose
Description
Mean change in fasting glucose
Time Frame
12 months
Title
Hemoglobin A1c
Description
Mean change in Hemoglobin A1c
Time Frame
12 months
Title
Diabetes Remission and/or Improvements
Description
Proportion of subjects experiencing diabetes remission and/or improvements
Time Frame
12 months
Title
Diabetes Medication Dosage and Frequency Changes
Description
Mean change in the dosage and frequency of diabetes medications from baseline
Time Frame
12 months
Title
Serum Lipids
Description
Mean change in serum lipids
Time Frame
12 months
Title
Blood Pressure Changes
Description
Mean percent change in systolic/diastolic blood pressure
Time Frame
12 months
Title
Liver Changes using Fibroscan
Description
Change in Controlled Attenuation Parameter (CAP) Scores from baseline
Time Frame
12 months
Title
Nutritional Status
Description
Nutritional Status: changes in pre-albumin levels
Time Frame
12 months
Title
Albumin - Nutritional Status
Description
Nutritional Status: changes in albumin levels
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Université Laval
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus
We'll reach out to this number within 24 hrs